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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJonsson Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 and older

Consented for thyroid surgery for thyroid cancer or indeterminate thyroid nodule

Disqualifiers

Patients with concurrent malignancy

Trial population

Patients in endocrine surgery clinic sites across University of California, Los Angeles (UCLA) who have undergone thyroid fine needle aspiration biopsy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood and tissue samples

  • Electronic Health Record Review

    Other intervention

    Medical charts are reviewed

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: Ancillary-correlative (biospecimen collection)2 interventions

Trial outcomes

Primary outcomes

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 outcomes

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

Other outcomes

Sponsors and contacts

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