Actively Recruiting
Observational Study on Gender-based Impact on Safety and Efficacy of Lenvatinib in Patients With Radioiodine Refractory Differentiated Thyroid Cancer
Led by Regina Elena Cancer Institute · Updated on 2024-12-06
50
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
R
Regina Elena Cancer Institute
Lead Sponsor
U
University of Turin, Italy
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how gender differences affect the safety and effectiveness of lenvatinib in patients with radioiodine refractory differentiated thyroid cancer (DTC). Lenvatinib is an approved oral drug that inhibits certain growth factor receptors and has shown significant activity in treating DTC resistant to radioiodine treatment. This observational study aims to understand how men and women differ in their response and side effects from lenvatinib treatment in a real-world setting. Participants will be patients with refractory iodine DTC who are treated with lenvatinib following good clinical practice guidelines. The study observes patients as they receive lenvatinib, without assigning treatments, to assess differences in dose reduction needs, side effects, tumor response, progression-free survival, and overall survival over a one-year period. During the study, researchers will monitor and collect data on safety, toxicity, adverse events, tumor response according to RECIST criteria, and survival outcomes. These measures will help clarify gender-based differences in treatment effects. Participants will be followed for at least one year to evaluate these outcomes comprehensively.
CONDITIONS
Brief Title
Gender-based Impact on Safety and Efficacy of Lenvatinib in Patients With Differentiated Thyroid Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with refractory iodine differentiated thyroid cancer treated with lenvatinib
- Signed written informed consent
You will not qualify if you...
- Age less than 18 years
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants who are treated with lenvatinib as part of routine care are observed.
Duration - Up to 1 year
Participants receive lenvatinib treatment as recommended by clinical practice, with monitoring of safety and efficacy.
Visit frequency depends on routine clinical care; assessments focus on safety and treatment response.
Duration - Up to 1 year total including treatment
Participants are observed for ongoing safety and treatment outcomes after initial treatment period.
Visit schedule follows routine follow-up care.
Trial Site Locations
Total: 1 location
1
Regina Elena National Cancer Institute
Rome, Italy, 00144
Actively Recruiting
Research Team
M
Marialuisa Appetecchia, Prof
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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