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NCT Number: NCT03785574

Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule

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

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Key information

Age range

Up to 60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Follow up

Other

the follow up group would be naturely didived into 2 subgroups depending the hCG regression degree.

Other names: not chemotherapy immediately

Chemotherapy

Drug

First line treatments:low risk:Methotrexate or ACTD; high risk:EMA-CO

Other names: mtx for low risk

Primary outcomes

  1. chemotherapy cycles

    Time frame: 120 months

    the efficacy and number of treatment cycles in the chemotherapy group

  2. hCG declined to normal spontaneously of group B

    Time frame: 120 months

    the spontaneous regression rate in Group B

Secondary outcomes

  1. follow up of group A , B and C

    Time frame: 240 months

    the proportion of spontaneous regression in the follow-up groups, progression-free survival (PFS) and overall survival (OS) in the chemotherapy group

  2. lung nodules

    Time frame: 240 months

    the changes of lung nodules

Study contacts

Contact information is provided by the study sponsor or research team.

Xiao Li, dortor

CONTACT

[email protected]

008657189992206

Sponsors and collaborators

Lead sponsor

Women's Hospital School Of Medicine Zhejiang University

Other

Collaborators

  • First Affiliated Hospital of Wenzhou Medical University
  • Hangzhou Fuyang Women And Children Hospital
  • Huzhou Maternity and Child Health Care Hospital
  • Qilu Hospital of Shandong University
  • Shaoxing Shangyu Women And Children Hospital
  • The First People's Hospital of Yunnan
  • Tianjin Central Hospital of Gynecology Obstetrics
  • Tongji Hospital Affiliated to Tongji Medical College of HUST
  • Women and Children's Hospital of Ningbo University
  • Zhejiang Provincial Tongde Hospital

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2030
Study completion
2030
First posted
Dec 24, 2018
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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