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

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.

Study Overview

• Status: Suspended
• Conditions: Thyroid Gland Carcinoma; Thyroid Gland Nodule
• Intervention / Treatment: Procedure: Biospecimen Collection; Other: Electronic Health Record Review

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA / Jonsson Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with concurrent malignancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Ancillary-correlative (biospecimen collection); 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; Undergo collection of blood and tissue samples; Other: Electronic Health Record Review; Medical charts are reviewed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Investigators: Principal Investigator: James Wu, UCLA / Jonsson Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2020
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms; Thyroid Nodule
• Other Study ID Numbers: 19-002301 (Other Identifier: UCLA / Jonsson Comprehensive Cancer Center); NCI-2021-00108 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No