An Active Surveillance Program for Cases of Medullary Thyroid Carcinoma (MTC)
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|ClinicalTrials.gov Identifier: NCT01511393|
Recruitment Status : Enrolling by invitation
First Posted : January 18, 2012
Last Update Posted : February 28, 2018
|Condition or disease||Intervention/treatment|
|Diabetes Diabetes Mellitus, Type 2 Medullary Thyroid Carcinoma Weight Management||Other: No treatment given|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||6750 participants|
|Target Follow-Up Duration:||15 Years|
|Official Title:||Medullary Thyroid Carcinoma Surveillance Study: A Case-Series Registry|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||December 2035|
|Estimated Study Completion Date :||December 2035|
None. Non-interventional study.
Other: No treatment given
None. Non-interventional study.
- Annual incidence of MTC in the US to identify any possible increase related to the introduction of liraglutide, exenatide once-weekly, and other GLP-1 receptor agonists into the US market. [ Time Frame: Up to 15 years ]
- Family history of cancer (including history of MEN2A or MEN 2B, history of FMTC, history of RET proto-oncogene mutations), Patient demographic characteristics, Patient prior history of thyroid diseases [ Time Frame: Up to 15 years ]
- Dose and Duration of use of all previous diabetes medication exposures (including long acting and short acting GLP-1 receptor agonists, DPP4 inhibitors, and insulin) [ Time Frame: Up to 15 years ]
- Dose and Duration of use of all previous weight management drugs (including long acting GLP-1 receptor agonists). [ Time Frame: Up to 15 years ]
- Lifestyle factors such as smoking and alcohol use [ Time Frame: Up to 15 years ]
- Environmental exposures (occupational history, radioiodine exposure, nuclear fallout) [ Time Frame: Up to 15 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511393
|United States, West Virginia|
|United BioSource Corporation|
|Morgantown, West Virginia, United States, 26505-8065|
|Study Director:||Annette Stemhagen, DrPH, FISPE||United BioSource Corporation|