NCT04742608

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Feb 2020Feb 2027

Study Start

First participant enrolled

February 21, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2025

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Expected
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

5.3 years

First QC Date

February 3, 2021

Last Update Submit

March 6, 2026

Conditions

Thyroid Gland CarcinomaThyroid Gland Nodule

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • 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

Study Arms (1)

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 CollectionOther: Electronic Health Record Review

Interventions

Biospecimen CollectionPROCEDURE

Undergo collection of blood and tissue samples

Ancillary-correlative (biospecimen collection)
Electronic Health Record ReviewOTHER

Medical charts are reviewed

Ancillary-correlative (biospecimen collection)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Patients with concurrent malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, tissue

MeSH Terms

Conditions

Thyroid NeoplasmsThyroid Nodule

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • James Wu

    UCLA / Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 8, 2021

Study Start

February 21, 2020

Primary Completion

June 9, 2025

Study Completion (Estimated)

February 1, 2027

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)