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Molecular Markers in the Diagnostic and Prognostic Evaluation of Thyroid Cancer


N/A
1 Year
N/A
Not Enrolling
Both
Thyroid Cancer

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Trial Information

Molecular Markers in the Diagnostic and Prognostic Evaluation of Thyroid Cancer


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 two parts:

Part One: Retrospective review of archived surgical pathology specimens at 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.

Part Two: Prospective evaluation of thyroid cytologic specimens obtained at the time of the
fine needle aspiration biopsy which is done as standard of care in the evaluation of thyroid
nodules and goiters and peripheral blood samples at the time of biopsy or surgery in OHSU
patients. Molecular markers will be evaluated on preoperative cytologic material and
peripheral blood samples and compared with postoperative evaluation of molecular markers on
surgical specimens from the OHSU Cancer Institute Tissue Bank.

In both parts, 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) 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.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Time Frame:

7 years

Safety Issue:

No

Principal Investigator

Kathryn G. Schuff, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oregon Health and Science University

Authority:

United States: Institutional Review Board

Study ID:

OHSUeIRB2844

NCT ID:

NCT00598364

Start Date:

February 2007

Completion Date:

April 2013

Related Keywords:

  • Thyroid Cancer
  • thyroid
  • nodule
  • genetic
  • mutation
  • malignancy
  • Thyroid Neoplasms
  • Thyroid Diseases

Name

Location

Oregon Health & Science UniversityPortland, Oregon  97201