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Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv9
  2. Secondary endpoints: details revised at 1 of 2 entriesv8
  3. Primary completion date: Sep 1, 2024 to Sep 1, 2030v7 Show 5 more changesShow less
    • Study completion date: Sep 1, 2025 to Sep 1, 2030
    • Eligibility criteria expanded, about 48 words
    • Secondary endpoints: 1 to 2
    • Collaborators expanded, about 63 words
    • Study arms: 2 to 3
  4. Enrollment target: 306 to 30
    • Primary completion date: Sep 1, 2022 to Sep 1, 2024
    • Study completion date: Sep 1, 2023 to Sep 1, 2025
    v6
  5. Primary completion date: Sep 1, 2020 to Sep 1, 2022
    • Study completion date: Sep 1, 2021 to Sep 1, 2023
    • Study description expanded, about 88 words
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary endpoints revised (2)
    • Secondary endpoints: details revised at 1 of 1 entry
    • Eligibility criteria shortened, about 1 word
    v4
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Primary endpoints revised (2)
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT03785574
Lead Sponsor Women's Hospital School Of Medicine Zhejiang University
Collaborators: Qilu Hospital of Shandong University, Tongji Hospital Affiliated to Tongji Medical College of HUST, The First People's Hospital of Yunnan, Tianjin Central Hospital of Gynecology Obstetrics, Women and Children's Hospital of Ningbo University, First Affiliated Hospital of Wenzhou Medical University, Hangzhou Fuyang Women And Children Hospital, Zhejiang Provincial Tongde Hospital, Shaoxing Shangyu Women And Children Hospital, Huzhou Maternity and Child Health Care Hospital
Conditions
(from sponsor)		 Hydatidiform Mole, Gestational Trophoblastic Neoplasia
Related terms Gestational Trophoblastic Disease, Hydatidiform Mole
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov