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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01511393
First Posted: January 18, 2012
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Novo Nordisk A/S
AstraZeneca
GlaxoSmithKline
Eli Lilly and Company
Information provided by (Responsible Party):
United BioSource Corporation
  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 [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 15 Years
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 ]

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 ]
  • 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 ]

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

Detailed 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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
  • At least 18 years or older.

There are no other inclusion or exclusion criteria.

  Contacts and Locations
Information from the National Library of Medicine

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


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 ( Other Identifier: WHO )
First Submitted: November 30, 2011
First Posted: January 18, 2012
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Currently this is undecided for this 15 year registry. The Data Monitoring Committee is a group of external interdisciplinary consultants who oversee the registry data to review if there are any signals or safety concerns with patients who have taken any of the long-acting GLP-1 RAs and were diagnosed with medullary thyroid carcinoma.

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


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