Patients Derived Organoids in Ovarian Cancer
NCT06085404 ·
Ovarian Cancer RecruitingAmong cancer models, patients derived organoids (PDOs) best reproduce tumor's tissue architecture, intratumor heterogeneity and are able to mimic in vivo patients' drugs response. For these reasons, it has been designed a study to assess the feasibility of PDOs immune cells co-culture in OC patients and the concordance between ex vivo sensitivity and in vivo treatment response. If proven effective and reliable, PDOs could be introduced into clinical practice as empirical predictor of patients' response to antineoplastic drugs.
PhaseNA
TypeInterventional
Age18 Years – 80 Years
WhereRoma, Italy
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
▾Tap for detailsClick for full details — eligibility, all locations, contacts Using Aspirin to Improve Immunological Features of Ovarian Tumors
NCT05080946 ·
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
RecruitingThe purpose of the study is to evaluate the effectiveness of aspirin with neoadjuvant chemotherapy for decreasing markers of immune suppression in the tumor at interval debulking surgery, in women with diagnosed ovarian, fallopian tube, or peritoneal carcinoma
PhaseEARLY_Phase 1
TypeInterventional
Age18 Years
WhereTampa, Florida, United States + 3 more
SponsorH. Lee Moffitt Cancer Center and Research Institute
▾Tap for detailsClick for full details — eligibility, all locations, contacts Ovarian Tissue Cryopreservation Combined With Oocyte Cryopreservation Versus Oocyte Cryopreservation Alone
NCT07546123 · Oncological Disease, Fertility Preservation
RecruitingFertility preservation is a crucial aspect of care for oncological patients undergoing gonadotoxic treatments such as chemotherapy, radiotherapy, or surgery, which can significantly reduce ovarian reserve and cause infertility or premature menopause. Among available techniques, oocyte cryopreservation is well-established with high survival rates but requires controlled ovarian stimulation and may not be suitable for prepubertal patients or those needing urgent cancer therapy. Ovarian tissue cryopreservation offers advantages by preserving a larger number of primordial follicles, can be performed anytime in the menstrual cycle regardless of age, and also helps restore ovarian endocrine function. Combining ovarian tissue cryopreservation followed by oocyte cryopreservation may maximize fertility preservation by safeguarding more follicles and ensuring availability of mature oocytes. This study will collect data from two patient groups: Group 1: patients undergoing ovarian tissue cryopreservation followed by oocyte cryopreservation (combined treatment) Group 2: patients undergoing oocyte cryopreservation alone. Group assignment is based on planned gonadotoxic therapy and available time before treatment initiation, according to clinical practice. The study aims to compare the number of oocytes retrieved per ovarian stimulation cycle between the two groups, along with the oocyte retrieval rate (number of oocytes retrieved/number of aspirated follicles), number of mature oocytes (metaphase II), incidence of moderate ovarian hyperstimulation syndrome within 7 days post-retrieval, and correlations between serum estradiol and luteinizing hormone levels on trigger day and oocyte yield. Approximately 127 patients aged 18 to 46 will be consecutively enrolled at the UO Gynecology and Human Reproduction Pathophysiology, IRCCS AOUBO Policlinico di Sant'Orsola. This is a cross-sectional, single-center, observational study with both retrospective and prospective enrollment. The retrospective period considered is from January 1, 2022, to the study start date. The study duration is 4 years and 3 months.
Phase—
TypeObservational
Age18 Years – 46 Years
WhereBologna, Bologna, Italy
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003)
RecruitingResearchers are looking for other ways to treat relapsed high-grade serous ovarian cancer. Relapsed means the cancer came back after treatment. High-grade means the cancer cells grow and spread quickly. Serous means the cancer started in the cells that cover the ovaries, the lining of the belly, or in the fallopian tubes. Standard treatment (usual treatment) for people with relapsed high-grade serous ovarian cancer may include: * Chemotherapy, which is a treatment that uses medicine to destroy cancer cells or stop them from growing * Targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread Raludotatug deruxtecan (R-DXd) is a study treatment that is an antibody drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. Researchers want to know if R-DXd is safe to take with other treatments and if people tolerate them together. They also want to learn how many people have the cancer respond (gets smaller or goes away) to the treatments.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereNew Haven, Connecticut, United States + 27 more
SponsorMerck Sharp & Dohme LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts REVITALIZE: RCT to Reduce Fatigue in Adults With Ovarian Cancer on PARP Inhibitors
NCT06710548 ·
Ovarian Cancer, Advanced Ovarian Carcinoma, Fallopian Tube Carcinoma
RecruitingThe purpose of this study is to see whether a supportive intervention (REVITALIZE) reduces fatigue and its impact on daily life and activities for participants with ovarian cancer taking PARP inhibitors. The name of the study groups in this research study are: 1. REVITALIZE 2. Educational Materials
PhaseNA
TypeInterventional
Age18 Years
WhereAurora, Colorado, United States + 5 more
SponsorDana-Farber Cancer Institute
▾Tap for detailsClick for full details — eligibility, all locations, contacts Development and Management of Registry in Patients With Gynecologic Cancer in Korea
NCT05912972 · Cervical Cancer, Endometrial Cancer,
Ovarian Cancer RecruitingThe goal of this observational study is to identify and analyze the characteristics, treatment trends, prognostic factors and survival prognosis of Korean gynecologic cancer patients. Ultimately, the final goal is to contribute to the development of safe surgical methods and treatment for gynecologic cancer to improve survival rates.
Phase—
TypeObservational
Age18 Years
WhereSeoul, South Korea
SponsorAsan Medical Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts EARLY Study: Evaluating the Specificity and Feasibility of the EARLY Biomarker Panel for Ovarian Cancer Detection
NCT07491081 ·
Ovarian Cancer RecruitingThe overall aim of the EARLY study is to systematically evaluate the impact of blood collection protocols, storage temperatures, transport conditions, and time to processing on the stability of extracellular vesicle (EV) biomarkers associated with ovarian cancer, with the potential to inform and improve future ovarian cancer screening practices. This prospective study will inform future screening studies by: 1. Assessing the feasibility of participant recruitment and blood sample collection for extracellular vesicle analysis in a real-world healthcare setting, including evaluation of the practicality and effectiveness of these processes. 2. Evaluating the stability of collected and transported blood samples and isolated extracellular vesicles during shipment and storage. A total of 1,500 participants will be recruited through community groups across Queensland, Australia, in collaboration with the Mater Research Biobank. Eligible participants who provide informed consent will have approximately 30 mL of blood collected for extracellular vesicle analysis. Data will also be collected on demographics (e.g. age and ethnicity), lifestyle factors (e.g. smoking status), medical, surgical and gynaecological history, family history of cancer, date of last menstrual period, and use of hormone replacement therapy (HRT). Participation in the study will conclude after blood sample collection.
PhaseNA
TypeInterventional
Age50 Years – 74 Years
WhereBrisbane, Queensland, Australia + 1 more
SponsorQueensland Centre for Gynaecological Cancer
▾Tap for detailsClick for full details — eligibility, all locations, contacts Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome
NCT06576375 · Polycystic Ovary Syndrome
RecruitingIn PCOS (Polycystic Ovary Syndrome), studies have found impaired incretin secretion and activity, particularly in overweight/obese individuals. Conflicting results exist regarding glucagon-like peptide-1(GLP-1) levels in PCOS patients, with studies reporting reduced, normal, or increased levels. Incretin-based therapy has been suggested as a potential treatment to reverse prediabetes risk by preserving β-cell function in patients with impaired fasting glucose(IFG and impaired glucose tolerance(IGT). The study aims to compare the efficacy of Dapagliflozin to Metformin for the treatment of non-diabetic patients with polycystic ovary syndrome (PCOS).
PhasePhase 3
TypeInterventional
Age18 Years – 40 Years
WhereGiza, Egypt
SponsorFuture University in Egypt
▾Tap for detailsClick for full details — eligibility, all locations, contacts Specimen and Data Study for Ovarian Cancer Early Detection and Prevention
NCT00005095 · Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer
RecruitingRATIONALE: To improve strategies for detection and prevention of early-stage disease. PURPOSE: This research study is collecting specimens and data to develop better methods for early detection and prevention of ovarian cancer among the high risk population and those who have the disease.
Phase—
TypeObservational
Age18 Years – 80 Years
WhereChicago, Illinois, United States
SponsorNorthwestern University
▾Tap for detailsClick for full details — eligibility, all locations, contacts The Vanguard Study: Testing a New Way to Screen for Cancer
NCT06995898 · Bladder Carcinoma, Breast Carcinoma, Colorectal Carcinoma
RecruitingThe Vanguard Study is a feasibility study to explore several aspects of evaluating multi-cancer detection (MCD) tests in a future definitive randomized controlled trial. An MCD test measures markers in the blood in order to screen for multiple cancers simultaneously. There is a need to understand how MCDs may work as cancer screening tools. The goal of cancer screening is to reduce the burden of cancer by identifying cancers before they show symptoms or signs, when treatment is likely to be most effective. In this study, adults aged 45-75 without cancer will be randomly assigned to one of 3 groups: 2 separate MCD test groups or a control group. These two MCD tests will not be compared to each other but will be compared to cancers detected in the control group. This study will provide early information on how well MCD tests perform as cancer screening tools. It will also help researchers understand how patients and their doctors make decisions about their care when the MCD test result comes back as normal (negative) or abnormal (positive).
PhaseNA
TypeInterventional
Age45 Years – 75 Years
WherePleasanton, California, United States + 38 more
SponsorNational Cancer Institute (NCI)
▾Tap for detailsClick for full details — eligibility, all locations, contacts Development of a Cinical and Biological Database in Ovarian, Fallopian Tube and Peritoneal Cancers
NCT03976999 · Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Peritoneal Neoplasms
RecruitingA Clinical and Biological Database will provide to the scientific community a collection of blood and tissues with clinical datas to improve knowledge about cancer and help to develope new cancer treatments. This database is specific to epithetial ovarian cancer, Fallopian tube cancer and Primitive peritoneal cancer.
PhaseNA
TypeInterventional
Age18 Years
WhereMontpellier, France
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Sigvotatug Vedotin in Advanced Solid Tumors
NCT04389632 · Carcinoma, Non-Small Cell Lung, Squamous Cell Carcinoma of Head and Neck, HER2 Negative Breast Neoplasms
RecruitingThis trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether sigvotatug vedotin works to treat solid tumors. The study will have four parts. * Part A of the study will find out how much sigvotatug vedotin should be given to participants. * Part B will use the dose found in Part A to find out how safe sigvotatug vedotin is and if it works to treat solid tumors. * Part C of the study will find out how safe sigvotatug vedotin is in combination with these other drugs. * Part D will include people who have not received treatment. This part of the study will find out how safe sigvotatug vedotin is in combination with these other drugs and if these combinations work to treat solid tumors. * In Parts C and D, participants will receive sigvotatug vedotin with either: * Pembrolizumab or, * Pembrolizumab and carboplatin, or * Pembrolizumab and cisplatin.
PhasePhase 1
TypeInterventional
Age18 Years
WhereAnchorage, Alaska, United States + 157 more
SponsorSeagen, a wholly owned subsidiary of Pfizer
▾Tap for detailsClick for full details — eligibility, all locations, contacts cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
NCT05366881 · Brain Cancer,
Breast Cancer, Bladder Cancer
RecruitingThis is an observational case-control study to train and validate a genome-wide methylome enrichment platform to detect multiple cancer types and to differentiate amongst cancer types. The cancers included in this study are brain, breast, bladder, cervical, colorectal, endometrial, esophageal, gastric, head and neck, hepatobiliary, leukemia, lung, lymphoma, multiple myeloma, ovarian, pancreatic, prostate, renal, sarcoma, and thyroid. These cancers were selected based on their prevalence and mortality to maximize impact on clinical care. Additionally, the ability of the whole-genome methylome enrichment platform to detect minimal residual disease after completion of cancer treatment and to detect relapse prior to clinical presentation will be evaluated in lung cancer. This cancer was selected based on the existing clinical landscape and treatment availability.
Phase—
TypeObservational
Age40 Years
WhereDuarte, California, United States + 16 more
SponsorAdela, Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts Predictive Value of Progastrin Titer at Diagnosis and of Progastrin Kinetics During Treatment in Cancer Patients
NCT03787056 ·
Cancer,
Breast Cancer, Gastric Cancer
RecruitingProgastrin is a pro-hormone that, in physiological conditions, is maturated in gastrin in G cells of the stomach. The role of the gastrin is to stimulate the secretion of gastric acids during digestion. It is also important for the regulation of cell growth of the gastric mucosal. In a healthy person, progastrin is not detectable in the peripheral blood. However, progastrin is abnormally released in the blood of patients with different cancers (colorectal, gastric, ovarian, breast, cervix uterus, melanoma…) The gene GAST coding for progastrin is a direct target gene of the WNT/ß-catenin oncogenic pathway. The activation of this oncogenic pathway is an early event in cancer development. Chronic activation of the WNT/ß-catenin oncogenic pathway occurs in almost all human solid tumors and is a central mechanism in cancer biology that induces cellular proliferation, blocking of differentiation leading to primary tumor growth and metastasis formation. Progastrin measured in the peripheral blood of patients on treatments, could be a new powerful marker for diagnosis and prognosis at different stages.
PhaseNA
TypeInterventional
Age18 Years
WhereBron, France + 16 more
SponsorHospices Civils de Lyon
▾Tap for detailsClick for full details — eligibility, all locations, contacts Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer Patients
NCT04038619 ·
Colitis, Diarrhea, Malignant Genitourinary System Neoplasm
RecruitingThis trial studies how well fecal microbiota transplantation works in treating diarrhea or colitis (inflammation of the intestines) that is caused by certain types of medications (called immune-checkpoint inhibitors) in patients with genitourinary cancer. Fecal microbiota transplantation may effectively reduce the incidence of immune checkpoint inhibitor-induced diarrhea/colitis.
PhasePhase 1
TypeInterventional
Age18 Years
WhereHouston, Texas, United States
SponsorM.D. Anderson Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors
RecruitingThis Phase 1/2 study evaluates the safety, feasibility, and preliminary anti-tumor activity of allogeneic donor-derived CAR-NK cells in participants with advanced solid tumors. The CAR target antigen is selected for each participant after tumor profiling using a tissue biopsy and/or liquid biopsy. Participants will receive either a single-target or dual-target CAR-NK product based on the antigen profile.
PhasePhase 1 / Phase 2
TypeInterventional
Age8 Years – 85 Years
WhereBeijing, Beijing Municipality, China
SponsorEssen Biotech
▾Tap for detailsClick for full details — eligibility, all locations, contacts Role of RPL8 Protein Alterations in High-grade Serous Ovarian Carcinoma
RecruitingBackground and rationale of the study: From our preliminary analyses of a dataset on patients with high-grade serous ovarian carcinoma (HGSOC), available in the online database The Cancer Genome Atlas, we found that the gene encoding ribosomal protein L8 (RPL8) is amplified at a high frequency (\~30%) in HGSOC. Moreover, its mRNA expression is positively correlated with its genetic amplification-an observation not previously reported or studied in the literature. RPL8 is a structural component of the large ribosomal subunit, which is involved in protein synthesis. Based on this, and our preliminary data, we hypothesize that RPL8 amplification may play a role in ovarian cancer development. Understanding the impact of RPL8 amplification in ovarian cancer could provide new insights into the biology of this poorly understood cancer. Study objectives: The main objective of this project is to determine whether RPL8 can be used as a biomarker both for risk assessment and for patient stratification in choosing the most appropriate therapeutic option. Specifically, we aim to study: 1. The relationship between the genetic status of RPL8 and clinical outcomes. 2. The contribution of RPL8 amplification to treatment response. Type of human tissue under study: The analyses will be conducted on tumor tissue samples obtained from ovarian cancer resections. Some samples have already been collected and stored at the IRCCS, while others are yet to be gathered. Type of investigation: * Expression analysis of RPL8, C-MYC, and related genes (RT-PCR, ddPCR, WB, IHC). * Gene copy number analysis and mutation screening (ddPCR and similar molecular techniques). * Analysis of possible associations between pathological data, follow-up data, and therapeutic response outcomes in patients. Analysis methodology: Data on the genetic status, expression, and subcellular localization of RPL8 and C-MYC will be correlated with categorical and continuous variables related to the patients' medical history and clinical status. Differences between categorical variables will be analyzed using analysis of variance (ANOVA), the Mann-Whitney test, or the Kruskal-Wallis test, depending on whether data distribution is normal or not (assessed via the Kolmogorov-Smirnov test). Correlations between continuous variables will be evaluated using Pearson or Spearman tests, again based on data distribution.
Phase—
TypeObservational
Age18 Years
WhereBologna, BO, Italy
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
▾Tap for detailsClick for full details — eligibility, all locations, contacts Ovarian Reserve After Laparoscopic Cystectomy for Endometriotic and Non-Endometriotic Cysts
NCT07686783 · Ovarian Cysts, Endometriosis, Benign Ovarian Cyst
RecruitingWe will conduct this study to estimate the effect of laparoscopic cystectomy on ovarian reserve in endometriotic cysts versus non-endometriotic cysts.
PhaseNA
TypeInterventional
Age18 Years – 45 Years
WhereBanhā, Qalyubia Governorate, Egypt
SponsorBenha University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Trial of THEO-260 (Administered Via Intraperitoneal Route) in Ovarian Cancer Patients
NCT07211659 ·
Ovarian Cancer RecruitingA research study evaluating a new oncolytic virus, THEO-260, in patients with advanced ovarian cancer. The trial will investigate different doses of THEO-260 administered by the intraperitoneal route to identify a dose that is safe, well tolerated, and exhibits preliminary evidence of anti tumour activity.
PhasePhase 1
TypeInterventional
Age18 Years
WhereHouston, Texas, United States
SponsorTheolytics Limited
▾Tap for detailsClick for full details — eligibility, all locations, contacts Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers
NCT02830724 ·
Pancreatic Cancer, Renal Cell Cancer,
Breast Cancer RecruitingBackground: In a new cancer therapy, researchers take a person s blood, select a certain white blood cell to grow in the lab, and then change the genes of these cells using a virus. The cells are then given back to the person. This is called gene transfer. For this study, researchers will modify the person s white blood cells with anti-CD70. Objectives: To see if a gene transfer with anti-CD70 cells can safely shrink tumors and to be certain the treatment is safe. Eligibility: Adults age 18 and older diagnosed with cancer that has the CD70-expressing cancer. Design: Participants will be screened with medical history, physical exam, scans, and other tests. They may by admitted to the hospital. Leukapheresis will be performed. For this, blood is removed through a needle in the arm. A machine separates the white blood cells. The rest of the blood is returned through a needle in the other arm. Eligible participants will have an intravenous catheter placed in their upper chest. Over several days, they will get chemotherapy drugs and the anti-CD70 cells. They will recover in the hospital. Participants will take an antibiotic for 6 months after treatment. They will repeat leukapheresis. Participants will visit the clinic every 1-3 months for the first year after treatment, every 6 months for the second year, and then as determined by their physician. Follow-up visits will take 1-2 days. At each visit, participants will have lab tests, imaging studies, and a physical exam. Throughout the study, blood will be taken and participants will have many tests to determine the size and extent of their tumor and the treatment s impact.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years – 72 Years
WhereBethesda, Maryland, United States
SponsorNational Cancer Institute (NCI)
▾Tap for detailsClick for full details — eligibility, all locations, contacts