Development of Liquid Biopsy Technologies for Noninvasive Cancer Diagnostics in Patients With Suspicious Thyroid Nodules or Thyroid Cancer

Study Overview
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Brief Summary
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This study is being done to help researchers learn more about and successfully diagnose cancer using blood samples and tissue samples from surgeries in patients with suspicious thyroid nodules or thyroid cancer. Diagnosing cancer in this way, as opposed to biopsies, may be less invasive to the patient. Analyzing blood and tissues samples may also help researchers to differentiate non-cancerous tumors from thyroid cancer and detect high-risk mutations to guide treatment.

Detailed Description
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PRIMARY OBJECTIVE: I. Sensitivity and specificity of molecular profile of thyroid derived extracellular vesicles (EVs) as predictor of thyroid cancer. SECONDARY OBJECTIVES: I. Quantity of thyroid derived EVs captured in various stages of thyroid cancer. II. Whether quantity of EVs decreases in proportion to response to therapy in thyroid cancer patients. III. Optimal ribonucleic acid (RNA)/deoxyribonucleic acid (DNA) panel in thyroid tumor derived EVs to diagnose thyroid cancer. OUTLINE: Patients undergo collection of blood samples on the day of surgery following anesthesia but prior to incision and approximately 4-6 weeks after surgery. Patients who undergo remnant ablation after total thyroidectomy with radioactive iodine have an additional blood sample collected. Patients also undergo collection of tissue samples following surgical resection of the thyroid. Patients' medical records are also reviewed.

Official Title
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Isolation and Characterization of Extracellular Vesicles in Patients With Thyroid Nodules and Thyroid Cancer

Conditions
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Thyroid Gland Carcinoma, Thyroid Gland Nodule

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Other: Electronic Health Record Review


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 and older Consented for thyroid surgery for thyroid cancer or indeterminate thyroid nodule Exclusion Criteria: Patients with concurrent malignancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ancillary-correlative (biospecimen collection)<br>Patients undergo collection of blood samples on the day of surgery following anesthesia but prior to incision and at the first routine blood test following surgery. Patients who undergo remnant ablation after total thyroidectomy with radioactive iodine have an additional blood sample collected. Patients also undergo collection of tissue samples following surgical resection of thyroid nodule or thyroid cancer. Patients' medical records are also reviewed. | Procedure: Biospecimen Collection<br>* Undergo collection of blood and tissue samples<br>Other: Electronic Health Record Review<br>* Medical charts are reviewed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of molecular profile of thyroid-derived extracellular vesicles |  | Up to 3 years | 
| Specificity of molecular profile of thyroid-derived extracellular vesicles |  | Up to 3 years | 
| Negative predictive value of molecular profile of thyroid-derived extracellular vesicles |  | Up to 3 years | 
| Positive predictive value of molecular profile of thyroid-derived extracellular vesicles |  | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of thyroid-derived extracellular vesicles captured in patients with localized, regional, and distant disease versus benign thyroid adenomas |  | Up to 3 years | 
| Quantity of thyroid-derived extracellular vesicles captured in patients with excellent, indeterminate, biochemically incomplete, and structural incomplete responses to initial therapy |  | Up to 3 years | 
| Combination of ribonucleic acid/deoxyribonucleic acid-based tests that can be perf thyroid-derived extracellular vesicles |  | Up to 3 years |