Development and Implementation of The Thyroid Tumor and Cancer Collaborative Registry (TCCR)

Trial Information

Development and Implementation of The Thyroid Tumor and Cancer Collaborative Registry (TCCR)

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.