Evaluation of DNA Methylation Signatures for the Diagnosis and Management of 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 Procedure, Electronic Health Record Review, Needle Biopsy.
- Who it may be relevant to
- Registry conditions: Thyroid Gland Carcinoma. Basic parameters: from 18 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
Evaluation of DNA Methylation Signatures in Diagnosis and Management of Thyroid Nodules
Overview
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.
Detailed description
PRIMARY OBJECTIVE:
I. To evaluate the effect of Diagnostic DNA Methylation Signatures (DDMS-2) results (positive predictive value \[PPV\], negative predictive value \[NPV\], sensitivity and specificity) on physician decision-making for clinical management of 800 indeterminate thyroid nodules.
SECONDARY OBJECTIVES:
I. To determine sensitivity and specificity, PPV, NPV of DDMS-2 with 1450 needle biopsies including 800 needle biopsies with indeterminate cytopathology.
II. Compare the diagnostic accuracy between DDMS-2 and two currently used diagnostic approaches based on genetic alterations and gene expression within the same prospective cohort of 800 indeterminate needle biopsies.
OUTLINE:
Patients undergo needle biopsy for collection of tissue samples. Tissue samples are analyzed using DDMS-2. Patients' medical records are also reviewed.
Interventions
- Procedure Diagnostic Procedure
Analysis via DDMS-2 - Other Electronic Health Record Review
Review of medical records - Procedure Needle Biopsy
Undergo needle biopsy
Primary outcome measures
- Sensitivity of Diagnostic Deoxyribonucleic Acid (DNA) Methylation Signatures (DDMS-2) [Time frame: Up to 5 years]
- Specificity of DDMS-2 [Time frame: Up to 5 years]
- Positive predictive value (PPV) of DDMS-2 [Time frame: Up to 5 years]
- Negative predictive value (NPV) of DDMS-2 [Time frame: Up to 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- City of Hope Medical Center — Duarte
Identifiers
NCT: NCT05229341 · 21129 · NCI-2021-12556 · 21129 · P30CA033572