This study is conducted in the United States of America (USA). The aim of the study is to
monitor the number of annual new adult cases of medullary thyroid carcinoma (MTC) and to
establish a registry for these new cases in order to identify any possible increase
related to the introduction of liraglutide, exenatide once-weekly, and other GLP-1
receptor agonists into the US market.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01511393.
Locations matching your search criteria
United States
New Jersey
New Brunswick
Rutgers Cancer Institute of New JerseyStatus: Active
Name Not Available
This active surveillance program will monitor for any signal indicating a possible
association between treatment with long-acting GLP-1 RAs and the development of MTC in
the United States population. Given the very low incidence of MTC in the general
population, the expected rate of exposure to long-acting GLP-1 RAs, the anticipated long
latency of the potential outcome under study and the limited data on underlying risk
factors for development of MTC other than RET proto-oncogene mutations, an active
surveillance program is the most efficient means of identifying a possible association
between MTC and products in the long-acting GLP-1 RAs class. Given the uncertainty of the
association of MTC in humans treated with these drugs, a study duration of at least
fifteen years from the time of market introduction of the first long-acting GLP-1 RA was
thought to provide evidence of an association, if one exists. If such an association is
identified, a case-control study will be initiated to quantify the association.
The MTC registry is a Food and Drug Administration (FDA) post-marketing requirement for
long-acting GLP-1 RA products. Because of the rarity of MTC and in order to minimize
inconvenience to patients, physicians, and state cancer registries, FDA encouraged
sponsors of long-acting GLP-1 RAs to work collaboratively to conduct this registry.
Consequently, the MTC Registry Consortium has been formed for this purpose.
The MTC Registry Consortium refers to the Sponsors with approved long-acting GLP-1 RAs
who have a contractual agreement to participate in the MTC Registry.
This active surveillance program for cases of MTC will be conducted with assistance from
the North American Association of Central Cancer Registries (NAACCR). NAACCR is a
collaborative umbrella organization for cancer registries, government agencies,
professional organizations, and private groups in North America interested in improving
the quality and use of cancer registry data. All of the central cancer registries in the
U.S. and Canada are members of NAACCR, including those that participate in SEER.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationNovo Nordisk A/S
