Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule

Gestational Trophoblastic Neoplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03785574
• Other study ID #: CSEM 012
• Status: Recruiting
• Phase: N/A
• Start date: December 24, 2018
• Est. completion date: September 1, 2025

Study information

• Verified date: October 2021
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: Xiao Li, dortor
• Phone: 008657189992206
• Email: 5198008[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 60 Years

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

Related Conditions & MeSH terms

• Gestational Trophoblastic Disease
• Gestational Trophoblastic Neoplasia
• Hydatidiform Mole

Intervention

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

Locations

Country	Name	City	State
China	Weiguo Lv	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	chemotherapy cycles	chemotherapy cycles to achieve hCG normalization and failure to first line	20 month
Primary	hCG declined to normal spontaneously of group B	The proportion of patients with hCG level declined to normal spontaneously of group B	20
Secondary	follow up of lung nodules	the change of the lung nodules during follow up in group B and C	32 month