NCT03785574

Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Women's Hospital School Of Medicine Zhejiang University · Academic / Other
• Sex: Female
• Age: 60 Years
• Healthy volunteers: Not accepted

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

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)

Conditions

• Hydatidiform Mole
• Gestational Trophoblastic Neoplasia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-12-24
• Primary completion: 2030-09-01
• Completion: 2030-09-01
• First posted: 2018-12-24
• Last updated: 2026-03-16

Locations

1 site across 1 country: China