Clinical Trial on Thyroid Cancer - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Thyroid Cancer

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.

Study Type

Observational

Enrollment (Actual)

847

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Oregon
  - Portland, Oregon, United States, 97239
    - Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome is histologic lesion (benign (Graves, Hashimoto's, follicular adenoma or subtype of malignant lesion). Time Frame: 7 years	7 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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	7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OHSU Knight Cancer Institute

Investigators

Principal Investigator: Kathryn G. Schuff, M.D., Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

January 10, 2008

First Submitted That Met QC Criteria