Molecular Markers in Thyroid Cancer

Thyroid Cancer Clinical Trial

Official title:

Molecular Markers in the Diagnostic and Prognostic Evaluation of Thyroid Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00598364
• Other study ID #: OHSUeIRB2844
• Status: Completed
• Phase: N/A
• First received: January 10, 2008
• Last updated: December 5, 2014
• Start date: February 2007
• Est. completion date: October 2010

Study information

• Verified date: December 2014
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 847
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is histologic lesion (benign (Graves, Hashimoto's, follicular adenoma or subtype of malignant lesion).		7 years	No
Secondary	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		7 years	No