Molecular Markers in Thyroid Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by OHSU Knight Cancer Institute
Sponsor:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00598364
First received: January 10, 2008
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to evaluate how common gene mutations are in benign and malignant thyroid lesions.


Condition
Thyroid Cancer

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 13 Years
Official Title: Molecular Markers in the Diagnostic and Prognostic Evaluation of Thyroid Cancer

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • The primary outcome is histologic lesion (benign (Graves, Hashimoto's, follicular adenoma or subtype of malignant lesion). [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The main secondary outcome to be measured in malignant lesions includes measures of biologic behavior of malignant lesions including capsular and angiolymphatic invasion, local invasion and lymph node metastases at presentation [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: February 2007
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Thyroidectomy or neck dissection
Patients with thyroid cancer or benign thyroid disease (nodules or goiter) who underwent thyroidectomy and/or neck dissection as standard of care.

Detailed Description:

The overall objective of this study is to evaluate the prevalence of molecular markers in patients with benign and malignant thyroid lesions. This study consists of:

Retrospective review of archived surgical pathology specimens at Oregon Health & Science University (OHSU) from patients with thyroid cancer or benign thyroid disease (nodules or goiter) who underwent thyroidectomy and/or neck dissection as standard of care. Molecular markers will be evaluated on archived tissue.

Molecular markers will be correlated with clinical information extracted from OHSU medical records: histologic subtype of cancer, measures of tumor aggressiveness (capsular and angiolymphatic invasion, local invasion, lymph node and distant metastases, TNM stage(TNM Classification of Malignant Tumours)) and clinical outcome (recurrence, distant metastases and death).

Patients with other malignancies presenting for standard of care services will have peripheral blood collected for DNA, RNA and buffy coat/white blood cells as a "positive" control for the DNA/RNA isolation techniques and mutation assays, as other cancers commonly express some of the same mutations. Normals will have peripheral blood collected for DNA, RNA and buffy coat/white blood cells as a "negative" control for the DNA/RNA isolation techniques and mutation assays.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with thyroid cancer or benign thyroid disease (nodules or goiter) who underwent thyroidectomy and/or neck dissection as standard of care.

Criteria

Inclusion Criteria:

  • Age 1 - 100
  • Benign or malignant thyroid lesion, other malignancy or no thyroid abnormality
  • Pathologic specimen available for analysis
  • Ability to provide informed consent (for prospective study, Part Two)
  • Age greater than age 18 (for normal controls)

Exclusion Criteria:

  • Patients without adequate data for analysis
  • Histopathologic or cytopathologic diagnosis of for medullary thyroid carcinoma (not derived from the thyroid follicular epithelium), thyroid lymphoma
  • Unwilling to participate or unable to provide informed consent
  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: NCT00598364

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Kathryn G Schuff, M.D.       schuffk@ohsu.edu   
Principal Investigator: Kathryn G. Schuff, M.D.         
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Principal Investigator: Kathryn G. Schuff, M.D. Oregon Health and Science University
  More Information

No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00598364     History of Changes
Other Study ID Numbers: OHSUeIRB2844
Study First Received: January 10, 2008
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by OHSU Knight Cancer Institute:
thyroid
nodule
genetic
mutation
malignancy

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

ClinicalTrials.gov processed this record on August 19, 2014