The Immune Landscape of Epithelial Ovarian Cancer
NCT05984875 · Epithelial Ovarian Cancer
RecruitingThis is a single center prospective observational study to characterize the immune landscape of newly diagnosed epithelial ovarian cancer (OC). Patients with newly diagnosed epithelial OC will be enrolled in 4 different cohorts: A) Newly diagnosed high grade serous or endometroid OC undergoing primary debulking surgery; B) Newly diagnosed high grade serous or endometroid OC undergoing neoadjuvant chemotherapy (NACT) followed by interval debulking surgery; C) Rare subtypes of epithelial OC (low grade serous, low grade endometrioid, clear cell, mucinous or carcinosarcoma) undergoing primary debulking surgery; D) Rare subtypes of epithelial OC (low grade serous, low grade endometrioid, clear cell, mucinous or carcinosarcoma) undergoing NACT followed by interval debulking surgery. A cohort of women undergoing adnexectomy for benign pathology will be enrolled (cohort E) for comparative analysis. Enrolled patients will be asked to provide the following biological samples at specified time points: archival and fresh tumor tissue, peripheral blood samples, rectal and vaginal swabs, ascites (when present). The main aim of the study is to characterize the immune landscape of epithelial OC in tumor tissue and peripheral blood and correlate the presence of myeloid-derived suppressive cells (MDSCs) and other immune infiltrates and of the systemic immune response with progression free interval (PFI) in epithelial OC.
Phase—
TypeObservational
Age18 Years
WhereBellinzona, Switzerland
SponsorOncology Institute of Southern Switzerland
▾Tap for detailsClick for full details — eligibility, all locations, contacts An Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib
NCT05887609 · Ovary Cancer, Peritoneal Cancer, Fallopian Tube Cancer
RecruitingThe Principal Investigator hypothesizes the combination of MIRV and Olaparib is an effective, and tolerable, maintenance therapy strategy in platinum sensitive recurrent ovarian cancer.
PhasePhase 2
TypeInterventional
Age18 Years – 100 Years
WhereAurora, Colorado, United States + 4 more
SponsorUniversity of Colorado, Denver
▾Tap for detailsClick for full details — eligibility, all locations, contacts OvS Breast: Ovarian Suppression in Breast Cancer Interventions
NCT06727487 · Breast Neoplasms
RecruitingThe goal of this clinical trial is to compare a combined intervention based on physical exercise, nutritional control, and individualized psycho-oncological support can achieve weight control and maintain adequate body composition in premenopausal women with localized BC with ER and/or PR expression who receive aLHRH in combination with TAM or AI as part of adjuvant treatment. The study's primary objectives are to evaluate the impact of the combined intervention on weight reduction and favorable modification of body composition in terms of reduction in body fat and increase in lean mass. The secondary objectives aim to evaluate the impact of the combined intervention program on CRF, heart rate (HR), capillary lactate levels, upper and lower body strength, physical functionality, and patient-reported outcomes (PROs). (exercise level, asthenia, self-perception, anxiety and depression), blood count and biochemistry values that could be modified, nutritional situation, and side effects of treatments.
PhaseNA
TypeInterventional
Age18 Years – 45 Years
WhereMadrid, Spain + 1 more
SponsorUniversidad Pontificia Comillas
▾Tap for detailsClick for full details — eligibility, all locations, contacts Comprehensive Multimodal Prehabilitation Alone or With Neoadjuvant Therapy Before Major Cancer Surgery
NCT07050771 · Hepatopancreaticobiliary (HPB) Malignancy, Ovarian Cancer (OvCa), Kidney Cancers
RecruitingIn this 2-arm, non-randomized, phase II trial, the investigators will evaluate the efficacy and safety of comprehensive multimodal prehabilitation (CMMP) alone or in combination with planned neoadjuvant (NAT) in pre-frail/frail patients with probable/proven pancreaticobiliary, ovarian, kidney, or bladder cancer prior to elective major cancer surgery (EMCS).
PhasePhase 2
TypeInterventional
Age18 Years
WhereHouston, Texas, United States
SponsorThe Methodist Hospital Research Institute
▾Tap for detailsClick for full details — eligibility, all locations, contacts AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer
NCT07218809 · Epithelial Ovarian Cancer
RecruitingThe intention of the study is to demonstrate superiority of AZD5335 versus standard of care by assessment of progression-free survival (PFS) in women with high-grade, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, expressing high or low FRα levels.
PhasePhase 3
TypeInterventional
Age18 Years
WhereFort Lauderdale, Florida, United States + 124 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Learn if 27T51, a Mucin-16 (MUC16) Protein Targeting Immune Cell Therapy, Administered Alone or in Combination is Safe and How Well it Works for Adult Participants With Recurrent or Treatment Resistant Ovarian Cancers
NCT06469281 · Epithelial Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer
RecruitingThis study is researching an experimental CAR T cell therapy called 27T51, referred to as study drug. The study drug is a MUC16 targeting immune cell therapy focused on adult female participants with recurrent or difficult to treat epithelial ovarian, primary peritoneal or fallopian tube cancer. This study has two (2) major parts: Phase 1a Dose Escalation and Phase 1b Dose Expansion. The aim of the dose escalation part will be to test the safety of 27T51 in a small number of participants to find the highest dose given to humans without unacceptable side effects. The aim of the dose expansion part will be to test 27T51 at the established dose level(s) from the dose escalation part and may include other medications given in combination with 27T51. Information collected from this study will help researchers understand more fully whether this immune cell therapy, also known as CAR T cell therapy, can be safely used to treat solid tumors such as ovarian cancer.
PhasePhase 1
TypeInterventional
Age18 Years
WhereBoston, Massachusetts, United States + 4 more
SponsorRegeneron Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003)
NCT06843447 · Ovarian Cancer Recurrent
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
WhereLouisville, Kentucky, United States + 15 more
SponsorMerck Sharp & Dohme LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Symptoms of Polycystic Ovarian Syndrome Ameliorated by Keto-Adaptation Pilot
NCT07227363 · PCOS (Polycystic Ovary Syndrome)
RecruitingThe SPARK- Pilot study (Symptoms of PCOS Ameliorated by Responses to Keto-adaptation) is a 12-week clinical trial at The Ohio State University designed to explore how different ways of achieving ketosis may improve reproductive and metabolic health in women with Polycystic Ovary Syndrome (PCOS). Participants will be randomly assigned to one of two groups: * A ketogenic diet group, following a low-carbohydrate, nutrient-dense meal plan. * A mixed diet plus ketone supplement group, following general dietary guidelines while taking an exogenous ketone supplement. The study will measure whether these approaches help restore regular ovulation and improve hormone balance, metabolism, and overall well-being. Optional imaging using MRI will also examine heart and ovarian health. This pilot study will help researchers understand if ketogenic nutrition strategies are a safe, effective way to support menstrual regularity and reduce PCOS-related symptoms, providing groundwork for larger clinical trials.
PhaseNA
TypeInterventional
Age18 Years – 40 Years
WhereColumbus, Ohio, United States
SponsorOhio State University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Functional Proteins in Polycystic Ovary Syndrome
NCT06793098 · Reproductive Age, PCOS (Polycystic Ovary Syndrome)
RecruitingThe concentration of functional proteins: kisspeptin, ghrelin, zonulin will be measured and compared in women with polycystic ovary syndrome (PCOS) and insulin resistance (IR), in women with PCOS without IR, and in women without PCOS.
Phase—
TypeObservational
Age18 Years – 45 Years
WhereKrakow, Poland
SponsorJagiellonian University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Effect of Magnesium and Levocarnitine on Metabolic and Clinical Outcomes in Women With Polycystic Ovarian Syndrome (PCOS)
NCT07298564 · Polycystic Ovary Syndrome (PCOS)
RecruitingPolycystic Ovary Syndrome (PCOS) is one of the most common endocrine disorders among women of reproductive age and is associated with metabolic abnormalities such as insulin resistance, dyslipidemia, and hormonal imbalance, which may lead to infertility and hirsutism. Despite the availability of several pharmacological treatments, many therapies fail to effectively address the underlying metabolic and endocrine dysfunctions of PCOS. Magnesium and L-carnitine are two essential nutrients that may play a synergistic role in improving insulin sensitivity, glucose metabolism, and lipid profile, as well as reducing oxidative stress and androgen production in women with PCOS. This randomized, triple-blind, placebo-controlled clinical trial aims to evaluate the effects of co-supplementation with magnesium and L-carnitine on glycemic control indices, lipid profile, and hirsutism in women with PCOS. A total of 84 eligible women aged 19-65 years diagnosed with PCOS according to the Rotterdam criteria will be recruited from Shohada Tajrish Hospital, Tehran, Iran. Participants will be randomly assigned to one of three groups: (1) magnesium supplementation (500 mg/day, in two 250 mg doses) plus L-carnitine placebo, (2) L-carnitine supplementation (1000 mg/day) plus magnesium (500 mg/day), or (3) placebo control group. The intervention period will last 12 weeks. Physical activity information will be collected using short form of International Physical Activity Questionnaire (IPAQ) and demographic information through a general information questionnaire. In order to evaluate dietary intake of patients in terms of energy(kcal/(day), carbohydrate(gr/day), protein(gr/day), fat intake(gr/day), saturated fatty acids (SFA) (gr/day), monounsaturated fatty acids (MUFA) (gr/day), polyunsaturated fatty acids (PUFA)(gr/day), Vitamin E (mg/day), Vitamin C (mg/day), Beta-carotene (mg/day) and Vitamin A (mg/day), cupper intake (mg/day), selenium intake (mg/day), and zink intake (mg/day), 24-hr recalls will be completed by interviewing the patient for 3 days (two normal days and a weekend day). Weight will be measured with the minimum dress and without shoes by using a digital balance scale of 100 grams and height will be measured without shoes by meters mounted to the wall with an accuracy of 0.5 centimeters. Then the body mass index will be calculated by dividing the weight (kg) by the square of the height (m), waist circumference will be measured in the narrowest area between the lowest lumbar spine and the iliac bone (cm), systolic and diastolic blood pressure will be measured after 15 minutes of rest, twice using the mercuric barometric measure and the mean will be reported as individual blood pressure. The blood sample will be taken after 12 hours of overnight fasting in three groups for measuring Fasting Blood Sugar (FBS) (mg/dL), lipid profile (mg/dL), Hemoglobin A1c (HbA1C) (percentage), serum insulin concentration (µIU/ml) and insulin resistance. Insulin resistance will be calculated using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) formula, and hirsutism score (using the modified Ferriman-Gallwey method) will be assessed at baseline and post-intervention. At the end of the study, counting the remaining capsules, the patient's compliance rate will be evaluated, and patients who have consumed less than 90% of their capsules will be excluded from the analysis.
PhaseNA
TypeInterventional
Age19 Years – 65 Years
WhereTehran, Tehran Province, Iran
SponsorBehnood Abbasi
▾Tap for detailsClick for full details — eligibility, all locations, contacts PRO for Fighting FT in Ovarian Cancer
NCT06032975 · Ovarian Cancer
RecruitingNon-profit, multicenter, prospective, observational study. This study aims to evaluate whether the articulated treatment algorithm that is now possible for OC patients does produce tangible changes of financial distress over the time and whether the determinants of financial distress change their relative weight over the time.
Phase—
TypeObservational
AgeAny
WhereNaples, Italy
SponsorNational Cancer Institute, Naples
▾Tap for detailsClick for full details — eligibility, all locations, contacts DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
NCT06953089 · Solid Tumors
RecruitingA Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors
PhasePhase 2
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 36 more
SponsorDualityBio Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts CT-95 in Advanced Cancers Associated With Mesothelin Expression
NCT06756035 · Mesothelin-Expressing Tumors, Epithelial Ovarian Cancer, Malignant Pleural Mesothelioma, Advanced
RecruitingThis is a Phase 1a/1b open-label, dose escalation study to evaluate the safety and efficacy of CT-95 (study drug), a humanized T cell engaging bispecific antibody targeting Mesothelin, in subjects with advanced solid tumors associated with Mesothelin expression.
PhasePhase 1
TypeInterventional
Age18 Years
WhereDenver, Colorado, United States + 7 more
SponsorContext Therapeutics Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts DOvEEgene/WISE Genomics: Diagnosing Ovarian and Endometrial Cancer Early Using Genomics
NCT02288676 · Ovarian Neoplasms, Endometrial Neoplasms, Endometrial Cancer
RecruitingThis study aims to develop and validate a test for detecting ovarian and endometrial cancers early. It relies on detecting somatic mutations that are associated with these cancers from a uterine pap test. A saliva sample is also collected that acts as an internal control and has the ability to detect deleterious germline mutations associated with common hereditary cancers (such as breast, ovarian, endometrial, colon, and pancreatic cancers). A machine learning classifier is then used to discriminate between cancer and benign disease.
Phase—
TypeObservational
Age18 Years
WhereMontreal, Quebec, Canada
SponsorMcGill University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Laboratory Study of Cancer & Immune Cells in Ascites Fluid of Ovarian Cancer Patients to Test Alternative Therapies
NCT03943316 · Ovarian Cancer
RecruitingAscites samples from women undergoing surgery for ovarian cancer will be collected for use in translational research.
Phase—
TypeObservational
Age18 Years
WhereAlbuquerque, New Mexico, United States
SponsorNew Mexico Cancer Research Alliance
▾Tap for detailsClick for full details — eligibility, all locations, contacts DETERMINE Trial Treatment Arm 04: Trastuzumab in Combination With Pertuzumab in Adult, Paediatric and Teenage/Young Adult Patients With Cancers With HER2 Amplification or Activating Mutations
NCT05786716 · Haematological Malignancy, Colorectal Neoplasms, Urinary Bladder Neoplasm
RecruitingThis clinical trial is looking at a combination of drugs called trastuzumab and pertuzumab. This combination of drugs is approved together as standard of care treatment for adult patients with breast cancer (often with other anti-cancer drugs). This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Trastuzumab and pertuzumab work in patients with these types of cancers which have a molecular alteration called HER2 amplification or HER2 activating mutation. Investigators now wish to find out if it will be useful in treating patients with other cancer types which are also HER2 amplified or HER2 mutated. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future. This trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.
PhasePhase 2 / Phase 3
TypeInterventional
Age12 Years
WhereBelfast, United Kingdom + 26 more
SponsorCancer Research UK
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies
NCT04503265 · Advanced Malignant Neoplasm, Breast Cancer, Ovarian Cancer
RecruitingATLAS-101 is a Phase I/II clinical trial of AMXI-5001 in adult participants with advanced malignancies who have previously failed other therapies. The study has two phases. The purpose of Phase I (Dose Escalation) is to confirm the appropriate treatment dose and Phase II (Dose Expansion) is to characterize the safety and efficacy of AMXI-5001.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 3 more
SponsorAtlasMedx, Incorporated
▾Tap for detailsClick for full details — eligibility, all locations, contacts SBRT Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARPi Therapy
NCT05990192 · Ovarian Cancer Recurrent
RecruitingSOPRANO is a multi-centre, randomised phase II trial which aims to assess the impact of Stereotactic radiotherapy (SBRT) and continuing treatment with a PARP inhibitor (PARPi) for patients with oligometastatic or oligoprogressive ovarian, fallopian tube and primary peritoneal carcinoma. SOPRANO will also establish the feasibility and acceptability of delivering SBRT in this setting.
PhasePhase 2
TypeInterventional
Age18 Years
WhereEdinburgh, Scotland, United Kingdom + 4 more
SponsorInstitute of Cancer Research, United Kingdom
▾Tap for detailsClick for full details — eligibility, all locations, contacts Patent Blue SLN in Early Ovarian Cancer Prospective Study (FIGO I-II) Evaluating Patent Blue SLN Mapping. Injection Into IP/UO Ligaments in Situ. Goals: Assess Feasibility and Accuracy vs Standard Lymphadenectomy to Minimize Surgical Morbidity
NCT07508306 · Sentinel Lymph Node Biopsy (SLNB), Early Stage Ovarian Tumors
Recruitingthe standard of care in case of early ovarian cancer (stage I or II) is a complete surgery. This surgery includes : hysterectomy (remove of the uterus), bilateral salpingo-oophorectomy (remove of the adnexa), omentectomy (remove of the epiploon), bilateral pelvic lymphadenectomy (remove of pelvic lymph nodes) and para-aortic lymphadenectomy (remove of para-aortic lymph nodes). This procedure is diagnostic, curative and prognostic surgery. In fact, it allows us provider care giver to stratify the stage of the cancer, hence we give the appropriate adjuvant therapy. However, this surgery, especially the extended lymphadenectomy, is associated with some risks: lymphocele, vessel injury, blood loss, morbidity, long recovery period ... In order to reduce these risks, we propose a sentinel lymph node biopsy. This intervention allows us to detect first lymph node relay whether pelvic or para-aortic. In our study, we chose the patent blue dye as a tracer. This tracer is widely used in oncologic surgery (for example in breast cancer) and approved but not in ovarian cancer yet. During surgery for early stage ovarian cancer, we will inject the patent blue dye on both side of the ovarian tumor. Then, we will check for first colorful lymph node, in both pelvic and para-aortic regions. We will send these dissected lymph node to pathology for analysis. Finally, we will continue the procedure as the standard of care. Our objective is to compare the results between the sentinel lymph node and the complete lymphadenectomy and to study the technique of sentinel lymph node biopsy using the blue patent dye as tracer.
Phase—
TypeObservational
Age18 Years
WhereLa Rabta, Tunisia
SponsorFaculty of Medicine of Tunis
▾Tap for detailsClick for full details — eligibility, all locations, contacts PPK Study Based on Quantitative Pharmacology in Patients With Pamipril
NCT05848648 · Ovarian Cancer
RecruitingThis is a non-intervention, prospective, one-arm, observational real-world clinical trial. The researchers plan to recruit at least 50 qualified patients. The main purpose of this study was to establish a population pharmacokinetic model of Pamiparib and to explore the correlation between its pharmacokinetic parameters and adverse reactions.
Phase—
TypeObservational
Age18 Years – 80 Years
WhereJinan, Shandong, China
SponsorQianfoshan Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts