ctDNA in Patients With Thyroid Nodules

Stopped early

Conditions studied: Thyroid Cancer, Thyroid Nodules, Thyroid Adenoma, Thyroiditis

In brief

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).

Key facts

Study ID

NCT02778412

Run by

Pathway Genomics

People needed

66

Starts

2016-05-01

Expected to finish

2017-08-01

Last updated by the study team

2017-08-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Prior history of cancer excluding basal cell carcinoma of the skin.

Where it is running

• Thyroid & Endocrine Center of Florida — Sarasota, Florida, United States

Full record on ClinicalTrials.gov

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