ctDNA in Patients With Thyroid Nodules

Thyroid Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02778412
• Other study ID #: Pathway Genomics-007
• Status: Terminated
• Phase: N/A
• First received: May 16, 2016
• Last updated: August 16, 2017
• Start date: May 2016
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: Pathway Genomics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 66
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Thyroid Adenoma
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms
• Thyroid Nodule
• Thyroid Nodules
• Thyroiditis

Locations

Country	Name	City	State
United States	Thyroid & Endocrine Center of Florida	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pathway Genomics

Country where clinical trial is conducted

United States, 

References & Publications (1)

Pupilli C, Pinzani P, Salvianti F, Fibbi B, Rossi M, Petrone L, Perigli G, De Feo ML, Vezzosi V, Pazzagli M, Orlando C, Forti G. Circulating BRAFV600E in the diagnosis and follow-up of differentiated papillary thyroid carcinoma. J Clin Endocrinol Metab. 2013 Aug;98(8):3359-65. doi: 10.1210/jc.2013-1072. Epub 2013 Jun 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Utility of plasma ctDNA measurements to detect thyroid cancer	Correlation between plasma ctDNA results with pathology from the diagnostic fine needle aspiration biopsy of the thyroid gland.	1 year
Primary	Screening characteristics of ctDNA measurement in patients with and without thyroid cancer.	Determination of true positive, false positive and predictive values for using ctDNA measurements to detect thyroid cancer.	1 year
Secondary	Determination of incident rate of new thyroid or other cancers in patients who underwent initial measurement of ctDNA.	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.	5 years