Omaha, Nebraska 68198


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.


Study summary:

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.


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


NCT ID:

NCT00693368


Primary Contact:

Principal Investigator
Whitney S. Goldner, MD
UNMC Internal Medicine (DEM), and Eppley Cancer Center at the University of Nebraska Medical Center

Michelle Ingram, BS
Phone: 402-559-6277
Email: michelle.ingram@unmc.edu


Backup Contact:

Email: ktreude@unmc.edu
Kelly Treude, BS
Phone: 402-559-7380


Location Contact:

Omaha, Nebraska 68198
United States

Deb Meyer
Phone: 402-559-6941

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2018

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