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Completed

NCT Number: NCT00598364

Molecular Markers in Thyroid Cancer

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

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Key information

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The primary outcome is histologic lesion (benign (Graves, Hashimoto's, follicular adenoma or subtype of malignant lesion).

    Time frame: 7 years

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Registry information

Official study title

Molecular Markers in the Diagnostic and Prognostic Evaluation of Thyroid Cancer

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jan 21, 2008
Registry last updated
Dec 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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