Collaborative Registry of Patients With Thyroid Cancer and/or Thyroid Tumors (TCCR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Nebraska
Sponsor:
Information provided by (Responsible Party):
Whitney Goldner, MD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT00693368
First received: June 6, 2008
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

RATIONALE: This is a registry to gather information about patients with thyroid cancer or thyroid nodules which will facilitate the future study of thyroid nodules and thyroid cancer. There is also an associated biobank with this study for tissue, blood, DNA, and urine.

PURPOSE: To develop a Thyroid nodule and Thyroid cancer registry with associated biobank which will facilitate the future study of Thyroid nodules and cancer to help with detection, diagnosis and appropriate treatment of Thyroid cancer.


Condition
Neoplasms, Thyroid

Study Type: Observational
Official Title: Development and Implementation of The Thyroid Tumor and Cancer Collaborative Registry (TCCR)

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Development and implementation of a web-based Thyroid Tumor and Cancer Collaborative Registry at the University of Nebraska Medical Center (UNMC)/Nebraska Medical Center (NMC) [ Time Frame: ongoing ] [ Designated as safety issue: No ]
    This is a registry that will continue to accrue patients indefinitely

  • Procurement and banking of excess biological material (i.e., thyroid tissue, tumor tissue and/or metastatic thyroid cancer tissue and/or paraffin embedded tissue) for future analysis [ Time Frame: ongoing ] [ Designated as safety issue: No ]
    This is a registry and biobank and will continue to accrue indefinitely

  • Collection and banking of blood, DNA, and urine samples for future analysis that will be proposed in future IRB submissions [ Time Frame: ongoing ] [ Designated as safety issue: No ]
    This is a registry with biobank and accrual will continue indefinitely


Biospecimen Retention:   Samples With DNA

serum, plasma, DNA, urine, tissue


Estimated Enrollment: 2000
Study Start Date: February 2008
Estimated Study Completion Date: January 2025
Estimated Primary Completion Date: January 2025 (Final data collection date for primary outcome measure)
Groups/Cohorts
Thyroid nodule and Cancer
No Treatment

Detailed Description:

OBJECTIVES:

Primary

  • To develop a web-based Thyroid Tumor and Cancer Collaborative Registry as a repository for socio-demographic, environmental, clinical history, family history, and biospecimen data collected at the University of Nebraska Medical Center/Nebraska Medical Center (UNMC/NMC) for study participants with a personal history of thyroid cancer and/or thyroid nodules.
  • To standardize clinical, environmental, socio-demographic, and family history data for thyroid cancer-related information to be collected and shared for research purposes by cancer research collaborators.
  • To procure and bank excess biological material (i.e., thyroid tissue, tumor tissue, metastatic thyroid cancer tissue, and/or paraffin embedded tissue) from participants with thyroid disease, including thyroid cancer and nonmalignant thyroid nodules, for future analysis by either providing a link to the clinical accession number of the samples stored by the NMC Procurement or by storing the samples in the UNMC Solid Tumor Bank.
  • To collect and bank blood, serum, and urine samples from participants for future analysis that will be proposed in future IRB submissions.
  • To collect, validate, and disseminate the thyroid cancer-related data to establish a high-risk cohort for future research into the molecular and biological bases of thyroid cancer susceptibility and for participation in interventional trials.

OUTLINE: Study participants undergo collection of data for inclusion in the Thyroid Tumor and Cancer Collaborative Registry (TCCR). Participants complete a self-administered on-line or paper-based survey and a medical history questionnaire at baseline to provide information on demographics, personal medical history, diet, lifestyle, physical activity, past or current environmental exposures, and family tree for cancer history. Additional information or clarification of the information provided is obtained by the TCCR research coordinator via structured telephone interview. The information that is gathered is recorded in a secured database for research purposes only and will be used to facilitate thyroid cancer research at the University of Nebraska Medical Center/Nebraska Medical Center (UNMC/NMC) and other collaborating institutions.

Study participants may also undergo review of their medical records and pathology reports to obtain additional medical and treatment-related information for inclusion in the registry. Retrospective and prospective disease-specific data (e.g., diagnosis, grade/stage, and laboratory values) and longitudinal outcome data (e.g., response to treatment, toxicity, survival, relapse) are obtained from the clinician involved in the study participant's care.

Representatives from the TCCR at UNMC may contact the study participant to obtain consent for additional uses of their stored medical history information, to obtain updated or additional information for the registry, or to participate in other research projects. Those who do not currently qualify for any studies will be asked for permission to contact them in the future in the event of any new information or studies that develop that would be relevant to their personal and/or family situation.

Previously collected thyroid tissue, tumor tissue, and/or metastatic thyroid cancer tissue from prior surgery or biopsies are obtained from the University of Nebraska Medical Center/Nebraska Medical Center department of pathology, outside pathology departments, or from the UNMC Solid Tumor Bank and saved for future studies performed at UNMC or at collaborating institutions. Registry participants may also undergo blood and urine sample collection for future studies.

After completion of study, study participants undergo medical chart review once a year to update relevant health and family histories.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults with thyroid nodules or thyroid cancer

Criteria

Inclusion Criteria:

  • Meets either of the following criteria:

    • Diagnosis or history of thyroid cancer
    • Presence of one or more thyroid nodules

PATIENT CHARACTERISTICS:

  • Able to provide written informed consent

PRIOR CONCURRENT THERAPY:

  • Not specified
  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: NCT00693368

Contacts
Contact: Michelle Ingram, BS 402-559-6277 michelle.ingram@unmc.edu
Contact: Kelly Treude, BS 402-559-7380 ktreude@unmc.edu

Locations
United States, Nebraska
Clinical Trials Patient Advocate Office Recruiting
Omaha, Nebraska, United States, 68198
Contact: Deb Meyer    402-559-6941      
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Whitney S. Goldner, MD UNMC Internal Medicine (DEM), and Eppley Cancer Center at the University of Nebraska Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: Whitney Goldner, MD, Associate Professor, Internal Medicine, DEM, University of Nebraska
ClinicalTrials.gov Identifier: NCT00693368     History of Changes
Other Study ID Numbers: 463-07, MXH:99-925-1355
Study First Received: June 6, 2008
Last Updated: January 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
thyroid cancer
thyroid nodules

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on September 22, 2014