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

This study is enrolling participants by invitation only.
Novo Nordisk A/S
Eli Lilly and Company
Information provided by (Responsible Party):
United BioSource Corporation Identifier:
First received: November 30, 2011
Last updated: May 29, 2015
Last verified: May 2015

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.

Condition Intervention
Diabetes Mellitus, Type 2
Medullary Thyroid Carcinoma
Other: No treatment given

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Medullary Thyroid Carcinoma Surveillance Study: A Case-Series Registry

Resource links provided by NLM:

Further study details as provided by United BioSource Corporation:

Primary Outcome Measures:
  • 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: January 2012 to December 2027 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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: January 2012 to December 2027 ] [ Designated as safety issue: No ]
  • Dose and duration of use of all previous diabetes medication exposures (including liraglutide, exenatide once-weekly, other GLP-1 agonists, DPP4 inhibitors, and insulin) [ Time Frame: January 2012 to December 2027 ] [ Designated as safety issue: No ]
  • Lifestyle factors such as smoking and alcohol use [ Time Frame: January 2012 to December 2027 ] [ Designated as safety issue: No ]
  • Environmental exposures (occupational history, radioiodine exposure, nuclear fallout) [ Time Frame: January 2012 to December 2027 ] [ Designated as safety issue: No ]

Estimated Enrollment: 6750
Study Start Date: January 2012
Estimated Study Completion Date: December 2027
Estimated Primary Completion Date: December 2027 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Questionnaire Other: No treatment given
Completion of a questionnaire


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

People with medullary thyroid carcinoma invited by either written invitation from the participating cancer registry or the diagnosing physician to participate in the study.


Inclusion Criteria:

  • A record of medullary thyroid carcinoma (MTC) identified from state/regional population-based cancer registries
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01511393

United States, West Virginia
United BioSource Corporation
Morgantown, West Virginia, United States, 26505-8065
Sponsors and Collaborators
United BioSource Corporation
Novo Nordisk A/S
Eli Lilly and Company
Study Director: Annette Stemhagen, DrPH, FISPE United BioSource Corporation
  More Information

Additional Information:
No publications provided

Responsible Party: United BioSource Corporation Identifier: NCT01511393     History of Changes
Other Study ID Numbers: NN2211-3965, U1111-1125-4362
Study First Received: November 30, 2011
Last Updated: May 29, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by United BioSource Corporation:
Glucagon like peptide
exenatide once weekly

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Thyroid Diseases
Thyroid Neoplasms
Diabetes Mellitus
Endocrine Gland Neoplasms
Endocrine System Diseases
Glucose Metabolism Disorders
Head and Neck Neoplasms
Metabolic Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial processed this record on August 26, 2015