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Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule
NCT03785574 · Women's Hospital School Of Medicine Zhejiang University
In plain English
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Official title
Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule，A Prospective Multicentre Randomized Controlled Trial
About this study
The hydatidiform mole patients with lung nodule ≥1.0cm will be randomized into 2 groups: A. treated with chemotherapy immediately, B. follow up until hCG level met FIGO diagnostic criteria of GTN (B1) or hCG level declined to normal spontaneously (B2). The clinical characteristics of patients were compared, especially chemotherapy cycles to achieve hCG normalization and failure to first-line chemotherapy.
Lung nodule \<1.0cm will directly treated as group C: follow up until hCG level met FIGO diagnostic criteria of GTN (C1) or hCG level declined to normal spontaneously (C2)
Eligibility criteria
Inclusion criteria
Eligible patients have to meet all of the following criteria:
1. Pathologically confirmed HM.
2. The lung nodules are detected by lung CT and metastatic lesions could not be excluded (before or after the suction dilation and curettage).
3. The hCG level does not meet FIGO diagnostic criteria (2018) of GTN.
4. The patients are willing to compliant with the study protocol and be followed up at regular intervals.
5. The patients agree to sign an informed consent form.
Exclusion criteria
1. The patients with a previous history of lung nodules.
2. The imaging impression of lung nodules suggested definitely caused by other diseases, such as tuberculosis, pneumonia, etc.
3. The patients have undergone prophylactic hysterectomy or chemotherapy.
4. Pathologically confirmed gestational trophoblastic neoplasia before and at enrollment.
5. Patients have immunosuppressive diseases or take immunosuppressants.
6. Patients are participating in other clinical trials at same time.
7. Patients were unable or unwilling to provide written informed consent.
Study design
Enrollment target: 30 participants
Allocation: randomized
Masking: none
Age groups: child, adult
Timeline
Starts: 2018-12-24
Estimated completion: 2030-09-01
Last updated: 2026-03-16
Interventions
Other: Follow upDrug: chemotherapy
Primary outcomes
- • chemotherapy cycles (120 months)
- • hCG declined to normal spontaneously of group B (120 months)
Sponsor
Women's Hospital School Of Medicine Zhejiang University · other
With: Qilu Hospital of Shandong University, Tongji Hospital Affiliated to Tongji Medical College of HUST, The First People's Hospital of Yunnan, Tianjin Central Hospital of Gynecology Obstetrics, Women and Children's Hospital of Ningbo University, First Affiliated Hospital of Wenzhou Medical University, Hangzhou Fuyang Women And Children Hospital, Zhejiang Provincial Tongde Hospital, Shaoxing Shangyu Women And Children Hospital, Huzhou Maternity and Child Health Care Hospital
Contacts & investigators
ContactXiao Li, dortor · contact · 5198008@zju.edu.cn · 008657189992206
InvestigatorXing Xie · principal_investigator, Women's Hospital, Zhejiang University School of Medicine
All locations (1)
Weiguo LvRecruiting
Hangzhou, Zhejiang, China