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

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ClinicalTrials.gov Identifier: NCT04742608
Recruitment Status : Recruiting
First Posted : February 8, 2021
Last Update Posted : February 8, 2021
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment
Thyroid Gland Carcinoma Thyroid Gland Nodule 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.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Isolation and Characterization of Extracellular Vesicles in Patients With Thyroid Nodules and Thyroid Cancer
Actual Study Start Date : February 21, 2020
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : February 1, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

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




Primary Outcome Measures :
  1. Sensitivity of molecular profile of thyroid-derived extracellular vesicles [ Time Frame: Up to 3 years ]
  2. Specificity of molecular profile of thyroid-derived extracellular vesicles [ Time Frame: Up to 3 years ]
  3. Negative predictive value of molecular profile of thyroid-derived extracellular vesicles [ Time Frame: Up to 3 years ]
  4. Positive predictive value of molecular profile of thyroid-derived extracellular vesicles [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. Quantity of thyroid-derived extracellular vesicles captured in patients with localized, regional, and distant disease versus benign thyroid adenomas [ Time Frame: Up to 3 years ]
  2. Quantity of thyroid-derived extracellular vesicles captured in patients with excellent, indeterminate, biochemically incomplete, and structural incomplete responses to initial therapy [ Time Frame: Up to 3 years ]
  3. Combination of ribonucleic acid/deoxyribonucleic acid-based tests that can be perf thyroid-derived extracellular vesicles [ Time Frame: Up to 3 years ]

Biospecimen Retention:   Samples With DNA
Blood, tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with concurrent malignancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04742608


Locations
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United States, California
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: James Wu    303-518-3186    jameswu@mednet.ucla.edu   
Principal Investigator: James Wu         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
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Principal Investigator: James Wu UCLA / Jonsson Comprehensive Cancer Center
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04742608    
Other Study ID Numbers: 19-002301
NCI-2021-00108 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
19-002301 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
First Posted: February 8, 2021    Key Record Dates
Last Update Posted: February 8, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Nodule
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms