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Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule

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ClinicalTrials.gov Identifier: NCT03785574
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Xing Xie, Women's Hospital School Of Medicine Zhejiang University

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). 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)

Condition or disease Intervention/treatment Phase
Hydatidiform Mole Gestational Trophoblastic Neoplasia Other: Follow up Drug: chemotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 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)
Primary Purpose: Treatment
Official Title: Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule,A Prospective Multicentre Randomized Controlled Trial
Actual Study Start Date : December 24, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2021


Arm Intervention/treatment
Active Comparator: A:chemotherapy immediately
Treated with chemotherapy immediately. First line treatments:low risk:Methotrexate or ACTD; high risk:EMA-CO
Drug: chemotherapy
First line treatments:low risk:Methotrexate or ACTD; high risk:EMA-CO
Other Name: mtx for low risk

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.

Other: Follow up
the follow up group would be naturely didived into 2 subgroups depending the hCG regression degree.
Other Name: not chemotherapy immediately

Drug: chemotherapy
First line treatments:low risk:Methotrexate or ACTD; high risk:EMA-CO
Other Name: mtx for low risk




Primary Outcome Measures :
  1. chemotherapy cycles [ Time Frame: 20 month ]
    chemotherapy cycles to achieve hCG normalization and failure to first line

  2. hCG declined to normal spontaneously of group B [ Time Frame: 20 ]
    The proportion of patients with hCG level declined to normal spontaneously of group B


Secondary Outcome Measures :
  1. follow up of lung nodules [ Time Frame: 32 month ]
    the change of the lung nodules during follow up in group B and C



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Ages Eligible for Study:   up to 60 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03785574


Contacts
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Contact: Xiao Li, dortor 008657189992206 5198008@zju.edu.cn

Locations
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China, Zhejiang
Weiguo Lv Recruiting
Hangzhou, Zhejiang, China
Contact: Weiguo Lv, Doctor    8657187061501    lixsure@163.com   
Sponsors and Collaborators
Women's Hospital School Of Medicine Zhejiang University
Investigators
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Principal Investigator: Xing Xie Women's Hospital, Zhejiang University School of Medicine

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Responsible Party: Xing Xie, Professor, Women's Hospital School Of Medicine Zhejiang University
ClinicalTrials.gov Identifier: NCT03785574     History of Changes
Other Study ID Numbers: CSEM 012
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xing Xie, Women's Hospital School Of Medicine Zhejiang University:
Pulmonary Nodule
Chemotherapy
Chorionic Gonadotrophin
Additional relevant MeSH terms:
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Hydatidiform Mole
Gestational Trophoblastic Disease
Neoplasms
Trophoblastic Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Pregnancy Complications, Neoplastic
Pregnancy Complications