ctDNA in Patients With Thyroid Nodules

Sponsor

Pathway Genomics (Industry)

Overall Status

Terminated

CT.gov ID

NCT02778412

Collaborator

(none)

Enrollment

Location

Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

When the DNA inside of human cells undergoes certain alterations (mutations), the cells may develop into a cancer. The cancer cells may shed this DNA into the blood stream. This circulating tumor DNA (ctDNA) can be detected by very sensitive, specialized laboratory tests. Measurement of ctDNA has been shown to be useful for following patients with known cancer. The purpose of this study is to examine blood specimens for the presence of ctDNA in individuals without known cancer who are scheduled to undergo a fine needle aspiration biopsy of the thyroid gland because of one or more thyroid nodules in order to see if the ctDNA test can detect a cancer at a very early stage. The results of this study should help define the role of ctDNA in the detection of early stage thyroid cancer and to define how sensitive it is (i.e. how well it picks up cancer when it is present) and how specific it is (i.e. how often is ctDNA found in patients with benign thyroid nodules).

Condition or Disease	Intervention/Treatment	Phase
Thyroid Cancer Thyroid Nodules Thyroid Adenoma Thyroiditis

Detailed Description

After the participants with thyroid nodules or other abnormalities have undergone the informed consent process, they will have 30 milliliters (approximately two tablespoons) of blood drawn. This will be done prior to the performance of the fine needle aspiration biopsy of the thyroid. If the patient has indicated a desire to receive the results of their test, they will receive a written description, as will their physician. The patients will be contacted yearly for up to 5 years by the study staff to learn whether they have been found to have a diagnosis of thyroid or other cancer.

Study Design

Study Type:

Observational

Actual Enrollment :

66 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Determination of the Utility of Plasma Circulating Tumor DNA (ctDNA) Measurements for Detection of Thyroid Cancer in Patients Undergoing Diagnostic Fine Needle Aspirations of the Thyroid

Study Start Date :

May 1, 2016

Actual Primary Completion Date :

Aug 1, 2017

Actual Study Completion Date :

Aug 1, 2017

Outcome Measures

Primary Outcome Measures

Utility of plasma ctDNA measurements to detect thyroid cancer [1 year]
Correlation between plasma ctDNA results with pathology from the diagnostic fine needle aspiration biopsy of the thyroid gland.
Screening characteristics of ctDNA measurement in patients with and without thyroid cancer. [1 year]
Determination of true positive, false positive and predictive values for using ctDNA measurements to detect thyroid cancer.

Secondary Outcome Measures

Determination of incident rate of new thyroid or other cancers in patients who underwent initial measurement of ctDNA. [5 years]
Subjects will be contacted yearly to obtain follow-up information regarding the development of thyroid or other cancer in order to see if the initial ctDNA measurement detected the cancer before it became clinically apparent.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 years of age or older;
presence of one or more thyroid nodules who are going to have a fine needle aspiration biopsy performed as part of their normal care.