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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04742608
Enrollment
250
Registered
2021-02-08
Start date
2020-02-21
Completion date
2027-02-01
Last updated
2026-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Gland Carcinoma, Thyroid Gland Nodule

Brief 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.

Detailed 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.

Interventions

PROCEDUREBiospecimen Collection

Undergo collection of blood and tissue samples

OTHERElectronic Health Record Review

Medical charts are reviewed

Sponsors

Jonsson Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Aged 18 and older * Consented for thyroid surgery for thyroid cancer or indeterminate thyroid nodule

Exclusion criteria

* Patients with concurrent malignancy

Design outcomes

Primary

MeasureTime frame
Sensitivity of molecular profile of thyroid-derived extracellular vesiclesUp to 3 years
Specificity of molecular profile of thyroid-derived extracellular vesiclesUp to 3 years
Negative predictive value of molecular profile of thyroid-derived extracellular vesiclesUp to 3 years
Positive predictive value of molecular profile of thyroid-derived extracellular vesiclesUp to 3 years

Secondary

MeasureTime frame
Quantity of thyroid-derived extracellular vesicles captured in patients with localized, regional, and distant disease versus benign thyroid adenomasUp to 3 years
Quantity of thyroid-derived extracellular vesicles captured in patients with excellent, indeterminate, biochemically incomplete, and structural incomplete responses to initial therapyUp to 3 years
Combination of ribonucleic acid/deoxyribonucleic acid-based tests that can be perf thyroid-derived extracellular vesiclesUp to 3 years

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJames Wu

UCLA / Jonsson Comprehensive Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026