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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Novo Nordisk A/S
AstraZeneca
GlaxoSmithKline
Eli Lilly and Company
Information provided by (Responsible Party):
United BioSource Corporation
ClinicalTrials.gov Identifier:
NCT01511393
First received: November 30, 2011
Last updated: September 1, 2015
Last verified: September 2015
  Purpose
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
Diabetes Mellitus, Type 2
Medullary Thyroid Carcinoma
Weight Management
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: Up to 15 years ] [ 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: Up to 15 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Dose and Duration of use of all previous weight management drugs (including long acting GLP-1 receptor agonists). [ Time Frame: Up to 15 years ] [ Designated as safety issue: No ]
  • Lifestyle factors such as smoking and alcohol use [ Time Frame: Up to 15 years ] [ Designated as safety issue: No ]
  • Environmental exposures (occupational history, radioiodine exposure, nuclear fallout) [ Time Frame: Up to 15 years ] [ 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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
Criteria

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 ClinicalTrials.gov identifier: NCT01511393

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

Additional Information:
Responsible Party: United BioSource Corporation
ClinicalTrials.gov Identifier: NCT01511393     History of Changes
Other Study ID Numbers: NN2211-3965  U1111-1125-4362 
Study First Received: November 30, 2011
Last Updated: September 1, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by United BioSource Corporation:
GLP1
Glucagon like peptide
liraglutide
exenatide extended release
albiglutide
dulaglutide

Additional relevant MeSH terms:
Diabetes Mellitus
Carcinoma
Thyroid Diseases
Diabetes Mellitus, Type 2
Thyroid Neoplasms
Carcinoma, Neuroendocrine
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on August 25, 2016