An observational study in Thyroid Gland Nodule, sponsored by City of Hope Medical Center. Recruiting at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by City of Hope Medical Center · Observational
This trial studies how well the diagnostic deoxyribonucleic acid (DNA) methylation signature works in detecting thyroid cancer in patients with thyroid nodules. Using diagnostic testing, such as the diagnostic DNA methylation signature, may be a less invasive way to check for thyroid cancer.
PRIMARY OBJECTIVES:
I. To validate a novel epigenetic thyroid nodule diagnostic test, diagnostic DNA methylation signature (DDMS) in a retrospective-prospective study with leftover of fine needle aspiration biopsies.
OUTLINE:
Previously collected FNA aspiration specimen samples are analyzed via DDMS assay. Participants undergo FNA aspiration for collection of tissue samples for analysis via DDMS assay.
After completion of study, patients are followed up yearly for 5 years.
207 studies on the registry are indexed under Thyroid Nodule; 64 are open to participants now.
This study's planned enrollment of 22 is below the median of 161 across 82 observational studies indexed under Thyroid Nodule.
Browse Thyroid Nodule studies →City of Hope Medical Center is the lead sponsor of 677 studies on the registry; 181 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 12 (39%) have results posted.
Counted across the registry records on this site, refreshed daily.
People undergoing fine needle aspiration.
Inclusion Criteria:
Previously collected FNA aspiration specimen samples are analyzed via DDMS assay. Participants undergo FNA aspiration for collection of tissue samples for analysis via DDMS assay.
Other: Diagnostic DNA Methylation Signature
Undergo collection of tissue samples
Also known as: DDMS
Sensitivity of the diagnostic deoxyribonucleic acid (DNA) methylation signature (DDMS)
Will be assessed by taking the ratio of the number of thyroid cancer specimens diagnosed as cancer using the DDMS and the total number of thyroid cancer specimens according to the final diagnosis. Will determine the 95% confidence intervals.
Time frame: Up to 5 years
Specificity of DDMS
Will be assessed by taking the ratio of the number of benign nodules diagnosed by DDMS and the total number of benign thyroid nodule specimens according to the final diagnosis. Will determine the 95% confidence intervals.
Time frame: Up to 5 years
Positive predictive value (PPV)
Will calculate PPV by dividing the number of true thyroid cancer specimens by the number of thyroid cancer diagnosis by DDMS. Will determine the 95% confidence intervals.
Time frame: Up to 5 years
Negative predictive value (NPV)
Will calculate NPV by dividing the number of benign nodules by the number of benign diagnosis by DDMS. Will determine the 95% confidence intervals.
Time frame: Up to 5 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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