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NCT Number: NCT05229341

Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules

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.

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Key information

Conditions

Thyroid Gland Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

Location status: Recruiting

Location contact

John H. Yim

CONTACT

[email protected]

626-218-3590

John H. Yim

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

diagnostic procedure

Procedure

Analysis via DDMS-2

Other names: Diagnostic Method, Diagnostic Technique, Diagnostic Test

Electronic Health Record Review

Other

Review of medical records

needle biopsy

Procedure

Undergo needle biopsy

Other names: Aspiration Biopsy, Puncture Biopsy

Primary outcomes

  1. Sensitivity of Diagnostic Deoxyribonucleic Acid (DNA) Methylation Signatures (DDMS-2)

    Time frame: Up to 5 years

    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.

  2. Specificity of DDMS-2

    Time frame: Up to 5 years

    The specificity will be estimated by taking the ratio of the number of true benign nodules diagnosed as benign by DDMS and the total number of true benign thyroid nodules. Will also determine the 95% confidence intervals.

  3. Positive predictive value (PPV) of DDMS-2

    Time frame: Up to 5 years

    PPV (number of true thyroid cancer specimens by DDMS / number of thyroid cancers diagnosis by DDMS) will be calculated. Will also determine the 95% confidence intervals.

  4. Negative predictive value (NPV) of DDMS-2

    Time frame: Up to 5 years

    NPV (number of true benign nodules diagnosed by DDMS/number of benign diagnosis by DDMS) will be calculated. Will also determine the 95% confidence intervals.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Evaluation of DNA Methylation Signatures in Diagnosis and Management of Thyroid Nodules

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 8, 2022
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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