Menu
Recruiting NCT03785574

Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule

No phase Interventional Hydatidiform Mole Gestational Trophoblastic Neoplasia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Follow up, chemotherapy.
Who it may be relevant to
Registry conditions: Hydatidiform Mole, Gestational Trophoblastic Neoplasia. Basic parameters: up to 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule，A Prospective Multicentre Randomized Controlled Trial

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

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) 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)

Interventions

  • Other Follow up
    the follow up group would be naturely didived into 2 subgroups depending the hCG regression degree.
  • Drug chemotherapy
    First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO

Primary outcome measures

  • chemotherapy cycles [Time frame: 120 months]
  • hCG declined to normal spontaneously of group B [Time frame: 120 months]
Secondary outcome measures (2)
  • follow up of group A , B and C [Time frame: 240 months]
  • lung nodules [Time frame: 240 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Weiguo Lv — Hangzhou

Identifiers

NCT: NCT03785574 · CSEM 012

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗