NCT01511393

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,750

participants targeted

Target at P75+ for all trials

Timeline
165mo left

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Jan 2012Dec 2039

First Submitted

Initial submission to the registry

November 30, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 18, 2012

Completed
27.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2039

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2039

Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

27.9 years

First QC Date

November 30, 2011

Last Update Submit

June 12, 2023

Conditions

DiabetesDiabetes Mellitus, Type 2Medullary Thyroid CarcinomaWeight Management

Keywords

GLP1Glucagon like peptideliraglutideexenatide extended releasedulaglutidesemaglutidesemaglutide tablets

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

  • 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

  • Dose and Duration of use of all previous weight management drugs (including long acting GLP-1 receptor agonists).

    Up to 15 years

  • Lifestyle factors such as smoking and alcohol use

    Up to 15 years

  • Environmental exposures (occupational history, radioiodine exposure, nuclear fallout)

    Up to 15 years

Study Arms (1)

Questionnaire

None. Non-interventional study.

Other: No treatment given

Interventions

No treatment givenOTHER

None. Non-interventional study.

Questionnaire

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • A record of medullary thyroid carcinoma (MTC) identified from state/regional population-based cancer registries
  • At least 18 years or older.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

United BioSource, LLC

Morgantown, West Virginia, 26505-8065, United States

Location

Related Publications (1)

  • Major-Pedersen A, McCullen MK, Sabol ME, Adetunji O, Massaro J, Neugut AI, Sosa JA, Hollenberg AN. A joint industry-sponsored data monitoring committee model for observational, retrospective drug safety studies in the real-world setting. Pharmacoepidemiol Drug Saf. 2021 Jan;30(1):9-16. doi: 10.1002/pds.5172. Epub 2020 Nov 24.

    PMID: 33179845DERIVED

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2Carcinoma, Medullary

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve Tissue

Study Officials

  • Annette Stemhagen, DrPH, FISPE

    United BioSource, LLC

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
15 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2011

First Posted

January 18, 2012

Study Start

January 1, 2012

Primary Completion (Estimated)

December 1, 2039

Study Completion (Estimated)

December 1, 2039

Last Updated

June 13, 2023

Record last verified: 2023-06

Locations

US(1)