Development of Liquid Biopsy Technologies for Noninvasive Cancer Diagnostics in Patients With Suspicious Thyroid Nodules or Thyroid Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospecimen Collection, Electronic Health Record Review.
- Who it may be relevant to
- Registry conditions: Thyroid Gland Carcinoma, Thyroid Gland Nodule. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Isolation and Characterization of Extracellular Vesicles in Patients With Thyroid Nodules and Thyroid Cancer
Overview
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.
Interventions
- Procedure Biospecimen Collection
Undergo collection of blood and tissue samples - Other Electronic Health Record Review
Medical charts are reviewed
Primary outcome measures
- Sensitivity of molecular profile of thyroid-derived extracellular vesicles [Time frame: Up to 3 years]
- Specificity of molecular profile of thyroid-derived extracellular vesicles [Time frame: Up to 3 years]
- Negative predictive value of molecular profile of thyroid-derived extracellular vesicles [Time frame: Up to 3 years]
- Positive predictive value of molecular profile of thyroid-derived extracellular vesicles [Time frame: Up to 3 years]
Secondary outcome measures (3)
- 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]
- 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]
- Combination of ribonucleic acid/deoxyribonucleic acid-based tests that can be perf thyroid-derived extracellular vesicles [Time frame: Up to 3 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles
Identifiers
NCT: NCT04742608 · 19-002301 · NCI-2021-00108 · 19-002301