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Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule

Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule

Recruiting
60 years and younger
Female
Phase N/A

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Overview

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)

Eligibility

Inclusion Criteria:

  1. pathologic confirmed hydatidiform mole
  2. 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
  3. the hCG level do not meet FIGO diagnostic criteria of GTN
  4. good compliance
  5. consent informed

Exclusion Criteria:

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

Study details
    Hydatidiform Mole
    Gestational Trophoblastic Neoplasia

NCT03785574

Women's Hospital School Of Medicine Zhejiang University

26 January 2024

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