Treatment options for hydatidiform mole with lung nodules
Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule，A Prospective Multicentre Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | N/A to 60 Years |
| Sex | Female |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT03785574 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hangzhou, Zhejiang
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.