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NCT Number: NCT03676647

Diagnostic DNA Methylation Signature in Diagnosing Thyroid Cancer After Fine-Needle Aspiration in Patients With Thyroid Nodules

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.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

Location status: Recruiting

Location contact

Maria Hahn

PRINCIPAL_INVESTIGATOR

Maria Hahn, PhD

CONTACT

[email protected]

626-256-4673

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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]).

Treatment and study plan

Diagnostic DNA Methylation Signature

Other

Undergo collection of tissue samples

Other names: DDMS

Primary outcomes

  1. Sensitivity of the diagnostic deoxyribonucleic acid (DNA) methylation signature (DDMS)

    Time frame: Up to 5 years

    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.

  2. Specificity of DDMS

    Time frame: Up to 5 years

    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.

  3. Positive predictive value (PPV)

    Time frame: Up to 5 years

    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.

  4. Negative predictive value (NPV)

    Time frame: Up to 5 years

    Will calculate NPV by dividing the number of benign nodules by the number of benign diagnosis by DDMS. Will 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

Retrospective-Prospective Collection of Thyroid Specimens After FNA

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Sep 19, 2018
Registry last updated
Jun 2, 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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