An Active Surveillance Program for Cases of Medullary Thyroid Carcinoma (MTC)

Launched by NOVO NORDISK A/S · Jan 12, 2012

Keywords

ClinConnect Summary

This study is a long-term safety registry in the United States that watches for new cases of medullary thyroid carcinoma (MTC), a rare type of thyroid cancer, to see if there is any link with long-acting GLP-1 receptor agonist diabetes medicines (such as liraglutide, exenatide weekly, dulaglutide, and semaglutide). It’s an observational program, meaning researchers do not give or change any treatment; instead they observe and collect information over time to notice any changes in cancer trends after these drugs entered the market. Because MTC is rare and can take many years to develop, the study plans to follow participants for up to 15 years.

Who can join: adults 18 years and older who have a diagnosed MTC and are identified through state or regional cancer registries. If you are invited by a participating registry or your doctor, you may be eligible to participate. The study aims to enroll about 6,750 people and involves completing questionnaires, with no treatment given as part of the study. Researchers will collect information on family cancer history, prior thyroid problems, past diabetes and weight-management medications, lifestyle, and environmental exposures. An independent Data Monitoring Committee will oversee safety signals, and if a potential link is found, researchers may start a follow-up case-control study. This is a FDA-post‑marketing safety effort sponsored by Novo Nordisk with collaborators. Data sharing is still being decided.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • A record of medullary thyroid carcinoma (MTC) identified from state/regional population-based cancer registries
• • At least 18 years or older.
• • There are no other inclusion or exclusion criteria.