Actively Recruiting
Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule, A Prospective Multicentre Randomized Controlled Trial
Led by Women's Hospital School Of Medicine Zhejiang University · Updated on 2026-03-16
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Women's Hospital School Of Medicine Zhejiang University
Lead Sponsor
Q
Qilu Hospital of Shandong University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying different treatment strategies for patients with hydatidiform mole who also have lung nodules. The study aims to provide clinical evidence to determine the best management approach for these patients, especially focusing on how to handle lung nodules of varying sizes and the associated risk of progressing to gestational trophoblastic neoplasia (GTN). Patients with lung nodules of 1.0 cm or larger are randomly assigned to immediate chemotherapy or to follow-up with treatment only if certain hCG criteria are met, while those with smaller nodules receive direct treatment based on follow-up results. The study groups include three approaches: Group A receives immediate chemotherapy, with low-risk patients treated with Methotrexate or ACTD and high-risk patients with EMA-CO. Group B patients with lung nodules 1.0 cm or larger are closely monitored until hCG levels either indicate GTN diagnosis or normalize spontaneously before chemotherapy is given if needed. Group C includes patients with smaller lung nodules who are similarly followed until hCG criteria guide further treatment. This prospective multicenter randomized controlled trial compares these strategies over time. Participants will undergo regular assessments including lung CT scans and hCG level monitoring to track disease progression and response to treatment. The main outcomes measured are the number of chemotherapy cycles and spontaneous hCG normalization over a 120-month period. Secondary outcomes include long-term follow-up of all groups and lung nodule changes over 240 months. Safety and effectiveness of treatment plans will be evaluated through ongoing monitoring and data collection throughout the study duration.
CONDITIONS
Brief Title
Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed hydatidiform mole.
- Lung nodules detected by lung CT that may be metastatic.
- hCG levels do not meet FIGO diagnostic criteria of gestational trophoblastic neoplasia.
- Willingness to comply with study protocol and attend regular follow-ups.
- Agreement to sign informed consent form.
You will not qualify if you...
- Previous history of lung nodules.
- Lung nodules caused by other diseases like tuberculosis or pneumonia.
- Prior prophylactic hysterectomy or chemotherapy.
- Pathologically confirmed gestational trophoblastic neoplasia before or at enrollment.
- Immunosuppressive diseases or use of immunosuppressants.
- Participation in other clinical trials at the same time.
- Unable or unwilling to provide written informed consent.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 120 months
Participants with lung nodules ≥1.0 cm are randomized to receive chemotherapy immediately or be followed up until hCG levels indicate the need for chemotherapy or normalize spontaneously. Participants with lung nodules <1.0 cm are followed up until hCG levels indicate the need for chemotherapy or normalize spontaneously.
Regular visits scheduled according to treatment or follow-up needs
Duration - Up to 240 months
Participants from all groups are monitored for long-term outcomes including lung nodules and hCG levels after treatment or spontaneous normalization.
Regular follow-up visits over the long term
Trial Site Locations
Total: 1 location
1
Weiguo Lv
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
X
Xiao Li, dortor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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