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

Официальное название

Isolation and Characterization of Extracellular Vesicles in Patients With Thyroid Nodules and Thyroid Cancer

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Biospecimen Collection
  Undergo collection of blood and tissue samples
• Другое Electronic Health Record Review
  Medical charts are reviewed

Первичные конечные точки

• Sensitivity of molecular profile of thyroid-derived extracellular vesicles [Срок оценки: Up to 3 years]
• Specificity of molecular profile of thyroid-derived extracellular vesicles [Срок оценки: Up to 3 years]
• Negative predictive value of molecular profile of thyroid-derived extracellular vesicles [Срок оценки: Up to 3 years]
• Positive predictive value of molecular profile of thyroid-derived extracellular vesicles [Срок оценки: Up to 3 years]

Вторичные конечные точки (3)

• Quantity of thyroid-derived extracellular vesicles captured in patients with localized, regional, and distant disease versus benign thyroid adenomas [Срок оценки: 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 [Срок оценки: Up to 3 years]
• Combination of ribonucleic acid/deoxyribonucleic acid-based tests that can be perf thyroid-derived extracellular vesicles [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

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

Критерии исключения

• Patients with concurrent malignancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles

Идентификаторы

NCT: NCT04742608 · 19-002301 · NCI-2021-00108 · 19-002301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗