Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule

  • STATUS
    Recruiting
  • End date
    Sep 1, 2023
  • participants needed
    306
  • sponsor
    Women's Hospital School Of Medicine Zhejiang University
Updated on 25 January 2021
hydatidiform mole

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

Description

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)

Details
Condition Hydatidiform Mole, Gestational trophoblastic disease, Gestational Trophoblastic Neoplasia, molar pregnancy, molar pregnancies
Treatment Chemotherapy, Follow Up
Clinical Study IdentifierNCT03785574
SponsorWomen's Hospital School Of Medicine Zhejiang University
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

pathologic confirmed hydatidiform mole
the lung nodule was detected by lung CT at the suction evacuation of molar pregnancy or during weekly hCG surveillance and lung metastasis cannot be excluded
the hCG level do not meet FIGO diagnostic criteria of GTN
good compliance
consent informed

Exclusion Criteria

history of lung nodule
lung nodule was conformed as other diseases such as Tuberculosis, pneumonia
already accepted with chemotherapy or hysterectomy
pathologic confirmed GTN
immunosuppressive diseases status or take immunosuppressive drugs
Participating in other clinical trials
unable or unwilling to sign informed consent
cannot or unwilling to comply with research requirements
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