Brief Title
ctDNA in Patients With Thyroid Nodules
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
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).
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 Type
Observational
Primary Outcome
Utility of plasma ctDNA measurements to detect thyroid cancer
Secondary Outcome
Determination of incident rate of new thyroid or other cancers in patients who underwent initial measurement of ctDNA.
Condition
Thyroid Cancer
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
66
Start Date
May 2016
Completion Date
August 2017
Primary Completion Date
August 2017
Eligibility Criteria
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.
Exclusion Criteria:
- Prior history of cancer excluding basal cell carcinoma of the skin.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Glenn D. Braunstein, M.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02778412
Organization ID
Pathway Genomics-007
Responsible Party
Sponsor
Study Sponsor
Pathway Genomics
Study Sponsor
Glenn D. Braunstein, M.D., Principal Investigator, Pathway Genomics
Verification Date
August 2017