Weiguo Lv
Hangzhou, Zhejiang, China
Location status: Recruiting
NCT Number: NCT03785574
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
Interested in participating?
Request InfoUp to 60 year
Female
Interventional
Not applicable
Hangzhou, Zhejiang, China
Location status: Recruiting
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)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Eligible patients have to meet all of the following criteria:
Exclusion criteria
the follow up group would be naturely didived into 2 subgroups depending the hCG regression degree.
Other names: not chemotherapy immediately
First line treatments:low risk:Methotrexate or ACTD; high risk:EMA-CO
Other names: mtx for low risk
Time frame: 120 months
the efficacy and number of treatment cycles in the chemotherapy group
Time frame: 120 months
the spontaneous regression rate in Group B
Time frame: 240 months
the proportion of spontaneous regression in the follow-up groups, progression-free survival (PFS) and overall survival (OS) in the chemotherapy group
Time frame: 240 months
the changes of lung nodules
Contact information is provided by the study sponsor or research team.
Women's Hospital School Of Medicine Zhejiang University
Other
Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule,A Prospective Multicentre Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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