Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule
Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule，A Prospective Multicentre Randomized Controlled Trial
Women's Hospital School Of Medicine Zhejiang University
30 participants
Dec 24, 2018
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria6
- Eligible patients have to meet all of the following 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 Criteria7
- 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.
Interventions
the follow up group would be naturely didived into 2 subgroups depending the hCG regression degree.
First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO
Locations(1)
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NCT03785574