Clinical trial NCT00598364: Molecular Markers in Thyroid Cancer
Official title: Molecular Markers in the Diagnostic and Prognostic Evaluation of Thyroid Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Cancer
Keywords: thyroid
nodule
genetic
mutation
malignancy
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
First posted: 2008-01-21
Enrollment: 847
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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 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

Primary outcomes:
measure: The primary outcome is histologic lesion (benign (Graves, Hashimoto's, follicular adenoma or subtype of malignant lesion).
timeFrame: 7 years
Secondary outcomes:
measure: 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
timeFrame: 7 years
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Kathryn G. Schuff, M.D.
role: PRINCIPAL_INVESTIGATOR
References: