CompletedNot Applicable

Molecular Profile of Metastatic Sporadic Medullary Thyroid Cancer Patients and Correlation With Vandetanib

Italy36 participantsStarted 2014-04

Plain-language summary

Vandetanib has been approved for patients with unresectable and/or metastatic medullary thyroid cancer (MTC) by the Food and Drug Administration, by the European Medicines Agency and, very recently, it has been licensed also by the Italian Regulatory Agency (AIFA) for the use in Italy. Vandetanib is an orally tyrosine kinase inhibitor (TKI) of vascular endothelial growth factor receptor (VEGFR), epidermal growth factor receptor (EGFR), and RET signaling. Circulating microRNAs levels could be influenced by the treatment procedures and we hypothesize that a TKI therapy could influence the levels of circulating miRNAs as well. Aim of this project is to seek non-invasive molecular markers potentially useful as prognostic tools for metastatic MTC patients.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * diagnosis of sMTC surgically treated (total thyroidectomy) * locally relapsed and or metastatic sMTC * metastatic MTC never treated with TKI before (valid for subjects treated with vandetanib only, in whom we will investigate the variation of circulating miRNA profile before and after vandetanib administration). Exclusion Criteria: * Patients with severe infection, active clinical co-morbidities, or a history of any other malignancy have been excluded.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Validation of a miRNA profile

Timeframe: 8 months

Define any correlations between the miRNA profiles and RET, and H- and K-RAS mutations

Timeframe: 8 months

Define a circulating miRNA profile

Timeframe: 8 months

Analyze any change in circulating miRNAs

Timeframe: 8 months

Correlate circulating miRNA profile with the burden of disease

Timeframe: 8 months

Evaluate the correlation between the response to vandetanib and the patients molecular profile

Timeframe: 8 months

Trial details

NCT IDNCT02268734

SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-12

View on ClinicalTrials.gov More Metastatic Sporadic Medullary Thyroid Cancer trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Validation of a miRNA profile

Timeframe: 8 months

Define any correlations between the miRNA profiles and RET, and H- and K-RAS mutations

Timeframe: 8 months

Define a circulating miRNA profile

Timeframe: 8 months

Analyze any change in circulating miRNAs

Timeframe: 8 months

Correlate circulating miRNA profile with the burden of disease

Timeframe: 8 months

Evaluate the correlation between the response to vandetanib and the patients molecular profile

Timeframe: 8 months