An Active Surveillance Program for Cases of Medullary Thyroid Carcinoma (MTC)
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Endocrine, Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | January 2012 |
| End Date: | December 2035 |
Medullary Thyroid Carcinoma Surveillance Study: A Case-Series Registry
This study is conducted in the United States of America (USA). The aim of the study is to
monitor the number of annual new 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.
monitor the number of annual new 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.
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.
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
