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NCT04742608 Clinical Trial

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

Thyroid Gland Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT04742608
Other study ID # 19-002301
Secondary ID NCI-2021-0010819
Status Suspended
Phase
First received
Last updated
Start date February 21, 2020
Est. completion date February 1, 2026

Study information
Verified date February 2024
Source Jonsson Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Suspended
Enrollment 250
Est. completion date February 1, 2026
Est. primary completion date February 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Aged 18 and older - Consented for thyroid surgery for thyroid cancer or indeterminate thyroid nodule Exclusion Criteria: - Patients with concurrent malignancy

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood and tissue samples
Other:
• Electronic Health Record Review
Medical charts are reviewed

Locations
Country Name City State
United States UCLA / Jonsson Comprehensive Cancer Center Los Angeles California

Sponsors (1)
Lead Sponsor Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity of molecular profile of thyroid-derived extracellular vesicles Up to 3 years
Primary Specificity of molecular profile of thyroid-derived extracellular vesicles Up to 3 years
Primary Negative predictive value of molecular profile of thyroid-derived extracellular vesicles Up to 3 years
Primary Positive predictive value of molecular profile of thyroid-derived extracellular vesicles Up to 3 years
Secondary Quantity of thyroid-derived extracellular vesicles captured in patients with localized, regional, and distant disease versus benign thyroid adenomas Up to 3 years
Secondary 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
Secondary Combination of ribonucleic acid/deoxyribonucleic acid-based tests that can be perf thyroid-derived extracellular vesicles Up to 3 years
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