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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Medullary Thyroid Carcinoma Surveillance Study: A Case-Series Registry

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01511393
• Other study ID #: NN2211-3965
• Secondary ID: U1111-1125-4362
• Status: Enrolling by invitation
• Start date: January 2012
• Est. completion date: December 2039

Study information

• Verified date: June 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 6750
• Est. completion date: December 2039
• Est. primary completion date: December 2039
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Neuroendocrine
• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Medullary Thyroid Carcinoma
• Thyroid Diseases
• Thyroid Neoplasms
• Weight Management

Intervention

Other:
• No treatment given
None. Non-interventional study.

Locations

Country	Name	City	State
United States	United BioSource, LLC	Morgantown	West Virginia

Sponsors (4)

Lead Sponsor	Collaborator
Novo Nordisk A/S	AstraZeneca, Eli Lilly and Company, United BioSource, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Up to 15 years
Secondary	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		Up to 15 years
Secondary	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)		Up to 15 years
Secondary	Dose and Duration of use of all previous weight management drugs (including long acting GLP-1 receptor agonists).		Up to 15 years
Secondary	Lifestyle factors such as smoking and alcohol use		Up to 15 years
Secondary	Environmental exposures (occupational history, radioiodine exposure, nuclear fallout)		Up to 15 years

External Links

•   AstraZeneca Pharmaceuticals LP