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

NCT ID: NCT04742608

Last Updated: 2025-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-21

Study Completion Date

2027-02-01

Brief Summary

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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

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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.

Conditions

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Thyroid Gland Carcinoma Thyroid Gland Nodule

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood and tissue samples

Electronic Health Record Review

Intervention Type OTHER

Medical charts are reviewed

Interventions

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Biospecimen Collection

Undergo collection of blood and tissue samples

Intervention Type PROCEDURE

Electronic Health Record Review

Medical charts are reviewed

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients with concurrent malignancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Wu

Role: PRINCIPAL_INVESTIGATOR

UCLA / Jonsson Comprehensive Cancer Center

Locations

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UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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James Wu

Role: primary

303-518-3186

Other Identifiers

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NCI-2021-00108

Identifier Type: REGISTRY

Identifier Source: secondary_id

19-002301

Identifier Type: OTHER

Identifier Source: secondary_id

19-002301

Identifier Type: -

Identifier Source: org_study_id

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