Clinical trial NCT04742608: Development of Liquid Biopsy Technologies for Noninvasive Cancer Diagnostics in Patients With Suspicious Thyroid Nodules or Thyroid Cancer
Official title: Isolation and Characterization of Extracellular Vesicles in Patients With Thyroid Nodules and Thyroid Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thyroid Gland Carcinoma
Thyroid Gland Nodule
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in endocrine surgery clinic sites across University of California, Los Angeles (UCLA) who have undergone thyroid fine needle aspiration biopsy.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients with concurrent malignancy

Primary outcomes:
measure: Sensitivity of molecular profile of thyroid-derived extracellular vesicles
timeFrame: Up to 3 years
measure: Specificity of molecular profile of thyroid-derived extracellular vesicles
timeFrame: Up to 3 years
measure: Negative predictive value of molecular profile of thyroid-derived extracellular vesicles
timeFrame: Up to 3 years
measure: Positive predictive value of molecular profile of thyroid-derived extracellular vesicles
timeFrame: Up to 3 years
Secondary outcomes:
measure: Quantity of thyroid-derived extracellular vesicles captured in patients with localized, regional, and distant disease versus benign thyroid adenomas
timeFrame: Up to 3 years
measure: Quantity of thyroid-derived extracellular vesicles captured in patients with excellent, indeterminate, biochemically incomplete, and structural incomplete responses to initial therapy
timeFrame: Up to 3 years
measure: Combination of ribonucleic acid/deoxyribonucleic acid-based tests that can be perf thyroid-derived extracellular vesicles
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: James Wu
role: PRINCIPAL_INVESTIGATOR
References: