Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule

NCT03785574 | Recruiting DMC

• 1 other identifier: CSEM 012
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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

Conditions

Hydatidiform Mole; Gestational Trophoblastic Neoplasia

Keywords

Pulmonary Nodule; Chemotherapy; Chorionic Gonadotrophin

Outcome Measures

Primary Outcomes (2)

• chemotherapy cycles

  the efficacy and number of treatment cycles in the chemotherapy group

  120 months

• hCG declined to normal spontaneously of group B

  the spontaneous regression rate in Group B

  120 months

Secondary Outcomes (2)

• follow up of group A , B and C

  240 months

• lung nodules

  240 months

Study Arms (3)

A:chemotherapy immediately

ACTIVE COMPARATOR

Treated with chemotherapy immediately. First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO

Drug: chemotherapy

B:follow up

EXPERIMENTAL

B1: follow up until hCG level met FIGO diagnostic criteria of GTN, then chemotherapy. B2: follow up until hCG level declined to normal spontaneously.

Other: Follow up; Drug: chemotherapy

C: lung nodule diameter <1.0 cm

EXPERIMENTAL

C1: follow up until hCG level met FIGO diagnostic criteria of GTN, then chemotherapy. C2: follow up until hCG level declined to normal spontaneously.

Other: Follow up; Drug: chemotherapy

Interventions

Follow up OTHER

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

Also known as: not chemotherapy immediately

B:follow up; C: lung nodule diameter <1.0 cm

chemotherapy DRUG

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

Also known as: mtx for low risk

A:chemotherapy immediately; B:follow up; C: lung nodule diameter <1.0 cm

Eligibility Criteria

• Age: Up to 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Weiguo Lv

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Hydatidiform Mole; Gestational Trophoblastic Disease

Interventions

Drug Therapy; Methotrexate

Condition Hierarchy (Ancestors)

Trophoblastic Neoplasms; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Pregnancy Complications, Neoplastic; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Xing Xie

  Women's Hospital, Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao Li, dortor

CONTACT

008657189992206; 5198008@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: lung nodule ≥1.0cm were 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). A:B=1:2，the sample size of group A and group B was 30 in total. Lung nodule \<1.0cm will be 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), it is an observation study and the sample volume depends on the enrolling time of group A and B.

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: December 24, 2018
• Study Start: December 24, 2018
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)