- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00598364
Molecular Markers in Thyroid Cancer
Molecular Markers in the Diagnostic and Prognostic Evaluation of Thyroid Cancer
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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The primary outcome is histologic lesion (benign (Graves, Hashimoto's, follicular adenoma or subtype of malignant lesion).
Time Frame: 7 years
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7 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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
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7 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kathryn G. Schuff, M.D., Oregon Health and Science University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OHSUeIRB2844
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Thyroid Cancer
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National Cancer Institute (NCI)TerminatedInsular Thyroid Cancer | Recurrent Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid Cancer | Anaplastic Thyroid Cancer | Stage III Follicular Thyroid Cancer | Stage III Papillary Thyroid CancerUnited States
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University of WashingtonNational Cancer Institute (NCI); GlaxoSmithKline; National Comprehensive Cancer...CompletedRecurrent Thyroid Cancer | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
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National Cancer Institute (NCI)CompletedRecurrent Thyroid Cancer | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
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University of PennsylvaniaCompletedMetastatic Medullary Thyroid Cancer | Metastatic Differentiated Thyroid Cancer | Metastatic Anaplastic Thyroid Cancer | Metastatic Poorly Differentiated Thyroid CancerUnited States
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National Cancer Institute (NCI)CompletedInsular Thyroid Cancer | Recurrent Thyroid Cancer | Stage II Follicular Thyroid Cancer | Stage II Papillary Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid CancerUnited States
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Children's Hospital of PhiladelphiaBayerRecruitingCancer | Pediatric Cancer | Differentiated Thyroid Cancer | Cancer, ThyroidUnited States
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Massachusetts General HospitalEli Lilly and CompanyRecruitingThyroid Carcinoma | Thyroid Cancer | Papillary Thyroid Cancer | Metastatic Thyroid Cancer | Follicular Thyroid Cancer | Unresectable Thyroid Gland CarcinomaUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedRecurrent Thyroid Cancer | Thyroid Gland Medullary Carcinoma | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
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H. Lee Moffitt Cancer Center and Research InstituteTerminatedThyroid Cancer, Medullary | Thyroid Cancer | Papillary Thyroid Cancer | Differentiated Thyroid Cancer | Poorly Differentiated Thyroid Gland Carcinoma | Follicular Thyroid CancerUnited States
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National Cancer Institute (NCI)CompletedRecurrent Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid CancerUnited States