Clinical trial · Interventional
Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules
Evaluation of DNA Methylation Signatures in Diagnosis and Management of Thyroid Nodules
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This clinical trial evaluates deoxyribonucleic acid (DNA) methylation signatures in diagnosing and managing thyroid nodules. The purpose of this research is to develop a new test for thyroid cancer. This test will use needle biopsies (small collections of tissue with a needle) from the thyroid to determine whether the participant has a malignant (cancer) or benign (not showing cancer) thyroid tumor. The information learned from this trial may help develop a more accurate test so that patients do not have unnecessary surgeries for nodules that are thought to be suspicious but are actually benign.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Gland Carcinoma | Thyroid Gland Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnostic Procedure | Procedure | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Needle Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (needle biopsy, DDMS-2)
- description
- Patients undergo needle biopsy for collection of tissue samples. Tissue samples are analyzed using DDMS-2. Patients' medical records are also reviewed.
- interventionNames
- Procedure: Diagnostic Procedure
- Other: Electronic Health Record Review
- Procedure: Needle Biopsy
Primary outcomes (4)
- measure
- Sensitivity of Diagnostic Deoxyribonucleic Acid (DNA) Methylation Signatures (DDMS-2)
- timeFrame
- Up to 5 years
- description
- The sensitivity of DDMS-2 will be estimated by taking the ratio of the number of true thyroid cancer specimens diagnosed as cancer by DDMS and the total number of thyroid cancer specimens. Will also determine the 95% confidence intervals.
- measure
- Specificity of DDMS-2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients without impaired decision-making capacity and who are undergoing needle biopsies for thyroid nodule diagnosis * Over the age of 18 * Any gender, race and ethnicity * Patients must provide informed consent prior to use of their tissues and clinical data Exclusion Criteria: * Children are excluded from the study, since the biology of children thyroid nodules is different from adults
References
Publications (0)
Data not yet available