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Clinical Performance Evaluation of a New Thyroglobulin Assay in Subjects with Differentiated Thyroid Cancer (DTC)


Title Clinical Performance Evaluation of a New Thyroglobulin Assay in Subjects with Differentiated Thyroid Cancer (DTC)
Therapeutic Area Thyroid Cancer
Principal Investigator Jacqueline Kung, MD
Min Age 22 Years
Gender Both
Contact Kim Vo
617 636-2843

Overview

The goal of the study is to collect information on how well a new diagnostic test works. The test was developed to measure proteins - called biomarkers - in blood, which aid diagnosis and treatment decisions in differentiated thyroid cancer (DTC). The biomarker thyroglobulin (Tg), which is measured through the course of the study, is already in use for treatment decisions and diagnosis in DTC patients in other countries, but has not yet been approved for use in the United States. Current Tg testing available to physicians is not always able to detect lower levels of disease. The new test under investigation is very sensitive and may potentially replace the uncomfortable hormone withdrawal/application in certain circumstances. The planned study is an observational study, meaning that you will receive all the care you normally would receive.

Study Details

Inclusion Criteria

Longitudinal Subject Cohort:
  • Subject >22 years of age at the time of enrollment
  • Diagnosed with thyroid cancer, and undergone thyroid surgery within the last 4 to 12 weeks.

Cross Sectional Subject Cohort
  • Subject >22 years of age at the time of enrollment
  • Diagnosed with thyroid cancer, and at least 4 years past their thyroid surgery.
  • Have no evidence of disease by ultrasound.

Exclusion Criteria

  • Subjects having less than near-total thyroidectomy
  • Known pregnancy or lactating

Study Requirements

Longitudinal Subject Cohort:
  • Come to Tufts Medical Center for five planned study visits over 2-years.
  • Tolerate having ~20ml of blood drawn at each visit.

Cross Sectional Subject Cohort
  • Come to Tufts Medical Center for one planned study visits.
  • Tolerate having ~20ml of blood drawn at the visit.