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Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule

Primary Purpose

Hydatidiform Mole, Gestational Trophoblastic Neoplasia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Follow up
chemotherapy
Sponsored by
Women's Hospital School Of Medicine Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hydatidiform Mole focused on measuring Pulmonary Nodule, Chemotherapy, Chorionic Gonadotrophin

Eligibility Criteria

undefined - 60 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Weiguo LvRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A:chemotherapy immediately

B:follow up

Arm Description

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

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

Outcomes

Primary Outcome Measures

chemotherapy cycles
chemotherapy cycles to achieve hCG normalization and failure to first line
hCG declined to normal spontaneously of group B
The proportion of patients with hCG level declined to normal spontaneously of group B

Secondary Outcome Measures

follow up of lung nodules
the change of the lung nodules during follow up in group B and C

Full Information

First Posted
December 21, 2018
Last Updated
October 21, 2021
Sponsor
Women's Hospital School Of Medicine Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT03785574
Brief Title
Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule
Official Title
Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule，A Prospective Multicentre Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 24, 2018 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Women's Hospital School Of Medicine Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydatidiform Mole, Gestational Trophoblastic Neoplasia
Keywords
Pulmonary Nodule, Chemotherapy, Chorionic Gonadotrophin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A:chemotherapy immediately
Arm Type
Active Comparator
Arm Description
Treated with chemotherapy immediately. First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO
Arm Title
B:follow up
Arm Type
Experimental
Arm Description
B1: follow up until hCG level met FIGO diagnostic criteria of GTN, then chemotherapy. B2: follow up until hCG level declined to normal spontaneously.
Intervention Type
Other
Intervention Name(s)
Follow up
Other Intervention Name(s)
not chemotherapy immediately
Intervention Description
the follow up group would be naturely didived into 2 subgroups depending the hCG regression degree.
Intervention Type
Drug
Intervention Name(s)
chemotherapy
Other Intervention Name(s)
mtx for low risk
Intervention Description
First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO
Primary Outcome Measure Information:
Title
chemotherapy cycles
Description
chemotherapy cycles to achieve hCG normalization and failure to first line
Time Frame
20 month
Title
hCG declined to normal spontaneously of group B
Description
The proportion of patients with hCG level declined to normal spontaneously of group B
Time Frame
20
Secondary Outcome Measure Information:
Title
follow up of lung nodules
Description
the change of the lung nodules during follow up in group B and C
Time Frame
32 month

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: pathologic confirmed hydatidiform mole 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 the hCG level do not meet FIGO diagnostic criteria of GTN good compliance consent informed Exclusion Criteria: history of lung nodule lung nodule was conformed as other diseases such as Tuberculosis, pneumonia already accepted with chemotherapy or hysterectomy pathologic confirmed GTN immunosuppressive diseases status or take immunosuppressive drugs Participating in other clinical trials unable or unwilling to sign informed consent cannot or unwilling to comply with research requirements
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao Li, dortor
Phone
008657189992206
Email
5198008@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xing Xie
Organizational Affiliation
Women's Hospital, Zhejiang University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weiguo Lv
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiguo Lv, Doctor
Phone
8657187061501
Email
lixsure@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule

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