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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: Female
Maximum Age: 60
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
China
Weiguo Lv
RECRUITING
Hangzhou
Contact Information
Primary
Xiao Li, dortor
5198008@zju.edu.cn
008657189992206
Time Frame
Start Date: 2018-12-24
Estimated Completion Date: 2030-09-01
Participants
Target number of participants: 30
Treatments
Active_comparator: A:chemotherapy immediately
Treated with chemotherapy immediately. First line treatments:low risk:Methotrexate or ACTD; high risk:EMA-CO
Experimental: B:follow up
B1: follow up until hCG level met FIGO diagnostic criteria of GTN, then chemotherapy.~B2: follow up until hCG level declined to normal spontaneously.
Experimental: C: lung nodule diameter <1.0 cm
C1: follow up until hCG level met FIGO diagnostic criteria of GTN, then chemotherapy. C2: follow up until hCG level declined to normal spontaneously.
Sponsors
Leads: Women's Hospital School Of Medicine Zhejiang University
Collaborators: Qilu Hospital of Shandong University, Tianjin Central Hospital of Gynecology Obstetrics, Tongji Hospital Affiliated to Tongji Medical College of HUST, Huzhou Maternity and Child Health Care Hospital, First Affiliated Hospital of Wenzhou Medical University, Shaoxing Shangyu Women And Children Hospital, The First People's Hospital of Yunnan, Hangzhou Fuyang Women And Children Hospital, Zhejiang Provincial Tongde Hospital, Women and Children's Hospital of Ningbo University

This content was sourced from clinicaltrials.gov