Diagnostic DNA Methylation Signature in Diagnosing Thyroid Cancer After Fine-Needle Aspiration in Patients With Thyroid Nodules
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diagnostic DNA Methylation Signature.
- Who it may be relevant to
- Registry conditions: Thyroid Gland Nodule. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Retrospective-Prospective Collection of Thyroid Specimens After FNA
Overview
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.
Detailed description
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.
Interventions
- Other Diagnostic DNA Methylation Signature
Undergo collection of tissue samples
Primary outcome measures
- Sensitivity of the diagnostic deoxyribonucleic acid (DNA) methylation signature (DDMS) [Time frame: Up to 5 years]
- Specificity of DDMS [Time frame: Up to 5 years]
- Positive predictive value (PPV) [Time frame: Up to 5 years]
- Negative predictive value (NPV) [Time frame: Up to 5 years]
Eligibility criteria
Inclusion criteria
- All patients undergoing FNA for thyroid nodule diagnosis.
- Any race and ethnicity are eligible for the study.
- Patient should have thyroid nodule(s) with indeterminate diagnosis after FNA (Bethesda category of indeterminate FNA \[III-V\]).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- City of Hope Medical Center — Duarte
Identifiers
NCT: NCT03676647 · 18077 · NCI-2018-01910 · 18077