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

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Brief Title

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

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.
    


Study Type

Observational


Primary Outcome

Sensitivity of molecular profile of thyroid-derived extracellular vesicles

Secondary Outcome

 Quantity of thyroid-derived extracellular vesicles captured in patients with localized, regional, and distant disease versus benign thyroid adenomas

Condition

Thyroid Gland Carcinoma

Intervention

Biospecimen Collection

Study Arms / Comparison Groups

 Ancillary-correlative (biospecimen collection)
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

250

Start Date

February 21, 2020

Completion Date

February 1, 2024

Primary Completion Date

February 1, 2023

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

James Wu, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04742608

Organization ID

19-002301

Secondary IDs

NCI-2021-00108

Responsible Party

Sponsor

Study Sponsor

Jonsson Comprehensive Cancer Center


Study Sponsor

James Wu, Principal Investigator, UCLA / Jonsson Comprehensive Cancer Center


Verification Date

January 2021