Treatment options for hydatidiform mole with lung nodules
Official title: Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule，A Prospective Multicentre Randomized Controlled Trial
Run by Women's Hospital School Of Medicine Zhejiang University · NCT03785574 · Data updated 2026-11-12
This study is testing different treatment options for patients with hydatidiform mole and lung nodules to see which approach works best for getting their hormone levels back to normal.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 60 Years |
| Sex | Women only |
| Enrollment | 30 (estimated) |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | December 24, 2018 |
| Main results expected | September 1, 2030 |
| Study ends | September 1, 2030 |
| Registry record updated | March 16, 2026 |
| Trial ID | NCT03785574 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with pathologically confirmed hydatidiform mole and lung nodules detected by CT that are not definitively caused by other diseases.
✕Probably not a fit
Patients with a history of lung nodules or those whose lung nodules are attributed to other conditions like tuberculosis or pneumonia may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate different therapeutic strategies for patients with hydatidiform mole who also have lung nodules measuring 1.0 cm or larger. Participants will be randomized into two groups: one receiving immediate chemotherapy and the other undergoing follow-up until specific hCG level criteria are met or decline spontaneously. For lung nodules smaller than 1.0 cm, patients will be monitored until the same hCG criteria are met or levels normalize. The study will compare clinical characteristics, including the number of chemotherapy cycles needed to achieve hCG normalization.
Why it matters
Potential benefit: If successful, this study could provide clearer guidelines for managing molar pregnancies with lung nodules, potentially improving patient outcomes.
How similar studies have gone: While there have been studies on hydatidiform mole and gestational trophoblastic neoplasia, this specific approach to managing lung nodules in these patients is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria Eligible patients have to meet all of the following criteria: 1. Pathologically confirmed HM. 2. The lung nodules are detected by lung CT and metastatic lesions could not be excluded (before or after the suction dilation and curettage). 3. The hCG level does not meet FIGO diagnostic criteria (2018) of GTN. 4. The patients are willing to compliant with the study protocol and be followed up at regular intervals. 5. The patients agree to sign an informed consent form. Exclusion criteria 1. The patients with a previous history of lung nodules. 2. The imaging impression of lung nodules suggested definitely caused by other diseases, such as tuberculosis, pneumonia, etc. 3. The patients have undergone prophylactic hysterectomy or chemotherapy. 4. Pathologically confirmed gestational trophoblastic neoplasia before and at enrollment. 5. Patients have immunosuppressive diseases or take immunosuppressants. 6. Patients are participating in other clinical trials at same time. 7. Patients were unable or unwilling to provide written informed consent.
Where it's running
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Weiguo Lv
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Principal investigator: Xing Xie — Women's Hospital, Zhejiang University School of Medicine
- Study coordinator: Xiao Li, dortor
- Email: 5198008@zju.edu.cn
- Phone: 008657189992206
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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National multicenter cohort of molar pregnancy in China
This project will see how often molar pregnancy turns into cancer and which clinical or pathological factors predict that, by following patients across multiple hospitals in China.
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A cohort study for patients with Gestational Trophoblastic Neoplasia
This study is gathering information from patients with Gestational Trophoblastic Neoplasia to better understand their treatment and outcomes, including fertility and recurrence rates.
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Exploring the psychological effects of GTN treatment on women
This study is trying to understand how women feel emotionally after finishing treatment for Gestational Trophoblastic Neoplasia and what kind of support they have received.
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Combination treatment of toripalimab and actinomycin-D for gestational trophoblastic neoplasia
This study is testing if combining two drugs, toripalimab and actinomycin-D, can help people with gestational trophoblastic neoplasia respond better than just using actinomycin-D alone.
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Using toripalimab and actinomycin-D to treat gestational trophoblastic neoplasia
This study is testing if a new combination of toripalimab and actinomycin-D can effectively treat gestational trophoblastic neoplasia in patients with a specific score, to see if it works better than standard chemotherapy.
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Camrelizumab plus apatinib for high‑risk gestational trophoblastic neoplasia
This trial will test whether adding camrelizumab and apatinib to chemotherapy helps women with ultra high‑risk or chemo‑refractory/relapsed high‑risk gestational trophoblastic neoplasia achieve remission.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.