An interventional study of Follow up and chemotherapy in Hydatidiform Mole and Gestational Trophoblastic Neoplasia, sponsored by Women's Hospital School Of Medicine Zhejiang University. Recruiting at 1 site in China. Open to female participants aged Up to 60 Years. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Women's Hospital School Of Medicine Zhejiang University · Not applicable, Interventional, and Treatment
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
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)
57 studies on the registry are indexed under Gestational Trophoblastic Disease; 16 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 35 interventional studies indexed under Gestational Trophoblastic Disease.
Browse Gestational Trophoblastic Disease studies →Women's Hospital School Of Medicine Zhejiang University is the lead sponsor of 79 studies on the registry; 49 are open to participants now.
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Eligible patients have to meet all of the following criteria:
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
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Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Histologically or cytologically confirmed
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Your pathology report is the document that shows this.
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Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treated with chemotherapy immediately. First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO
Drug: chemotherapy
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 · Drug: chemotherapy
C1: follow up until hCG level met FIGO diagnostic criteria of GTN, then chemotherapy. C2: follow up until hCG level declined to normal spontaneously.
Other: Follow up · Drug: chemotherapy
the follow up group would be naturely didived into 2 subgroups depending the hCG regression degree.
Also known as: not chemotherapy immediately
First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO
Also known as: mtx for low risk
chemotherapy cycles
the efficacy and number of treatment cycles in the chemotherapy group
Time frame: 120 months
hCG declined to normal spontaneously of group B
the spontaneous regression rate in Group B
Time frame: 120 months
follow up of group A , B and C
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
lung nodules
the changes of lung nodules
Time frame: 240 months
Plan to share: No
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Gestational Trophoblastic Disease →
Women's Hospital School Of Medicine Zhejiang University