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Status:

RECRUITING

Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule

Lead Sponsor:

Women's Hospital School Of Medicine Zhejiang University

Collaborating Sponsors:

Qilu Hospital of Shandong University

Tongji Hospital Affiliated to Tongji Medical College of HUST

Conditions:

Hydatidiform Mole

Gestational Trophoblastic Neoplasia

Eligibility:

FEMALE

Up to 60 years

Phase:

NA

Brief 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 randomi...

Detailed 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)...

Eligibility Criteria

Inclusion

  • Inclusion criteria
  • 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 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.

Exclusion

    Key Trial Info

    Start Date :

    December 24 2018

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    September 1 2030

    Estimated Enrollment :

    30 Patients enrolled

    Trial Details

    Trial ID

    NCT03785574

    Start Date

    December 24 2018

    End Date

    September 1 2030

    Last Update

    May 30 2025

    Active Locations (1)

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    Weiguo Lv

    Hangzhou, Zhejiang, China