An observational study in Thyroid Cancer, Thyroid Nodules and Thyroid Adenoma, sponsored by Pathway Genomics. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-21.
Sponsored by Pathway Genomics · Observational
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).
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.
207 studies on the registry are indexed under Thyroid Nodule; 64 are open to participants now.
This study's enrollment of 66 is below the median of 161 across 82 observational studies indexed under Thyroid Nodule.
Browse Thyroid Nodule studies →Pathway Genomics is the lead sponsor of 4 studies on the registry; none are open to participants now.
Compared within Thyroid Nodule, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Thyroid Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Individuals 18 year of age or older without a prior diagnosis of cancer who are going to undergo a fine needle aspiration biopsy of the thyroid gland as part of their standard care.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 5 years
Plan to share: Yes — The patient's physician will receive the results and the patients have the option to also receive the results.
This study is terminated, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Pathway Genomics