NCT05789667 Gender-based Impact on Safety and Efficacy of Lenvatinib in Patients With Differentiated Thyroid Cancer
| NCT ID | NCT05789667 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Regina Elena Cancer Institute |
| Condition | Differentiated Thyroid Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2020-05-27 |
| Primary Completion | 2024-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2020-05-27 with a primary completion date of 2024-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Lenvatinib is approved for the treatment of radioiodine refractory differentiated thyroid cancer. Despite gender can play a crucial role un in safety and efficacy of oncological product, little is know on gender difference in lenvatinb effacacy and safety in the context of radioiodine refractory differentiated thyroid cancer. The primary objective of the study is to assess safety and toxicity profile in male and female patients in terms of dose reduction. The secondary objectives are to assess sex and gender difference in: the number and the incidence of adverse events; response rate according to RECIST criteria 1.1; progression free survival, overall survival and duration of response.
Eligibility Criteria
Inclusion Criteria: * Patients with refractory iodine DTC treated with lenvatinib * Signed written informed consent Exclusion Criteria: \- Age \< 18 years
Contact & Investigator
Marialuisa Appetecchia, Prof
PRINCIPAL INVESTIGATOR
Regina Elena Cancer Institute
Frequently Asked Questions
Who can join the NCT05789667 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Differentiated Thyroid Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05789667 currently recruiting?
Yes, NCT05789667 is actively recruiting participants. Contact the research team at marialuisa.appetecchia@ifo.it for enrollment information.
Where is the NCT05789667 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT05789667 clinical trial?
NCT05789667 is sponsored by Regina Elena Cancer Institute. The principal investigator is Marialuisa Appetecchia, Prof at Regina Elena Cancer Institute. The trial plans to enroll 50 participants.
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