RecruitingNot Applicable

Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule

China30 participantsStarted 2018-12-24

Plain-language summary

The purpose of present study is to provide clinical evidences for the appropriate management of molar pregnancy with lung nodule. 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). Lung nodule \<1.0cm will directly treated as group C

Who can participate

Age range60 Years

SexFEMALE

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Inclusion criteria

✓. Pathologically confirmed HM.
✓. The lung nodules are detected by lung CT and metastatic lesions could not be excluded (before or after the suction dilation and curettage).
✓. The hCG level does not meet FIGO diagnostic criteria (2018) of GTN.
✓. The patients are willing to compliant with the study protocol and be followed up at regular intervals.
✓. The patients agree to sign an informed consent form.

Exclusion criteria

✕. The patients with a previous history of lung nodules.
✕. The imaging impression of lung nodules suggested definitely caused by other diseases, such as tuberculosis, pneumonia, etc.
✕. The patients have undergone prophylactic hysterectomy or chemotherapy.
✕. Pathologically confirmed gestational trophoblastic neoplasia before and at enrollment.
✕. Patients have immunosuppressive diseases or take immunosuppressants.
✕. Patients are participating in other clinical trials at same time.
✕. Patients were unable or unwilling to provide written informed consent.

What they're measuring

chemotherapy cycles

Timeframe: 120 months

hCG declined to normal spontaneously of group B

Timeframe: 120 months

Trial details

NCT IDNCT03785574

SponsorWomen's Hospital School Of Medicine Zhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-09-01

Contact for this trial

Xiao Li, dortor

008657189992206 5198008@zju.edu.cn

View on ClinicalTrials.gov More Hydatidiform Mole trials