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

Learn more about:
Related Clinical Trial
Three-dimensional Ultrasonography Thyroid Volume Measurement. Oral AMXT 1501 Dicaprate in Combination With IV DFMO Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules Impact of the COVID-19 Pandemic on Surgery for Thyroid Cancer Radiofrequency Ablation for the Treatment of Benign or Low Risk Thyroid Nodule Optimising Molecular Radionuclide Therapy Selpercatinib Before Surgery for the Treatment of RET-Altered Thyroid Cancer Development of Liquid Biopsy Technologies for Noninvasive Cancer Diagnostics in Patients With Suspicious Thyroid Nodules or Thyroid Cancer Function Integrity of Neck Anatomy in Thyroid Surgery An Investigational Scan (hpMRI) for Monitoring Treatment Response in Patients With Thyroid Cancer Undergoing Radiation Therapy and/or Systemic Therapy Vemurafenib Plus Copanlisib in Radioiodine-Refractory (RAIR) Thyroid Cancers Malignancy Predictors, Bethesda and TI-RADS Scores Correlated With Final Histopathology in Thyroid Diseases Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System Evaluation of a New CZT System Thermal Ablation and Spine Stereotactic Radiosurgery in Treating Patients With Spine Metastases at Risk for Compressing the Spinal Cord Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy Cabozantinib S-Malate in Treating Younger Patients With Recurrent or Refractory Solid Tumors Romidepsin in Treating Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Solid Tumors With Liver Dysfunction Modified Cormack Lehane Scores Evaluated by Laryngoscopy During Awake Versus Under General Anesthesia Parathyroid Reimplantation in Forearm Subcutaneous Tissue During Thyroidectomy: a Simple Way to Avoid Ipoparathyroidism and Evaluate Graft Function Efficacy of Fibrin Sealant to Reduce the Amount of Post-thyroidectomy Drain A Study Into the Effect of Seprafilm in Open Total Thyroidectomy Lenvatinib and Pembrolizumab in DTC Study of XL184 (Cabozantinib) in Adults With Advanced Malignancies Genomic Profiling of Nodular Thyroid Disease and Thyroid Cancer Comparative Study of Robot BABA Approach and Chest Breast Approach for Lateral Neck Dissection Sunitinib Malate in Treating Patients With Thyroid Cancer That Did Not Respond to Iodine I 131 and Cannot Be Removed by Surgery Cabozantinib-S-Malate in Treating Patients With Refractory Thyroid Cancer Iodine I-131 With or Without Selumetinib in Treating Patients With Recurrent or Metastatic Thyroid Cancer Trametinib in Increasing Tumoral Iodine Incorporation in Patients With Recurrent or Metastatic Thyroid Cancer Influence of Thyroid Hormones on the Woundhealing Process ctDNA in Patients With Thyroid Nodules Selumetinib in Treating Patients With Papillary Thyroid Cancer That Did Not Respond to Radioactive Iodine Aflibercept in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy Radioiodine Dosimetry Protocol for Thyroid Cancer Metastases Evaluation of Lancet Blood Sampling for Radioiodine Dosimetry in Thyroid Cancer Pazopanib Hydrochloride in Treating Patients With Advanced Thyroid Cancer Clinical Evaluation of 18F-DOPA Positron Emission Tomography in Medullary Thyroid Cancer Biomarkers to Distinguish Benign From Malignant Thyroid Neoplasm Gallium-68 Prostate Specific Membrane Antigen PET in Diagnosing Patients With Thyroid Cancer Effect of Polyglycolic Acid Mesh (Neoveil) in Thyroid Cancer Surgery The Effect of Coffee on the Absorption of Thyroid Hormone in Patients With Thyroid Carcinoma Lesion Dosimetry With Iodine-124 in Metastatic Thyroid Carcinoma Renal Tracer Elimination in Thyroid Cancer Patients Treated With 131-Iodine Trial of LBH589 in Metastatic Thyroid Cancer Enhancing Radioiodine (RAI) Incorporation Into BRAF Mutant, RAI-Refractory Thyroid Cancers With the BRAF Inhibitor Vemurafenib: A Pilot Study Prospective, Non-interventional, Post-authorization Safety Study That Includes All Patients Diagnosed as Unresectable Differentiated Thyroid Carcinoma and Treated With Sorafenib Phase II Study of the Optimal Scheme of Administration of Pazopanib in Thyroid Carcinoma Study of Sulfatinib in Treating Advanced Medullary Thyroid Carcinoma and Iodine-refractory Differentiated Thyroid Carcinoma Thyroid Cancer and Sunitinib Feasibility of Endoscopic Thyroidectomy for Thyroid Carcinoma Sorafenib Phase II Study for Japanese Anaplastic or Medullary Thyroid Carcinoma Patients Lipid Metabolic Status in Thyroid Carcinoma

Brief Title

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

Official Title

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

Brief Summary

      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.
    


Study Type

Interventional


Primary Outcome

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


Condition

Thyroid Gland Carcinoma

Intervention

Diagnostic Procedure

Study Arms / Comparison Groups

 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

1450

Start Date

October 22, 2021

Completion Date

October 22, 2026

Primary Completion Date

October 22, 2026

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

John H Yim, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT05229341

Organization ID

21129

Secondary IDs

NCI-2021-12556

Responsible Party

Sponsor

Study Sponsor

City of Hope Medical Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

John H Yim, Principal Investigator, City of Hope Medical Center


Verification Date

February 2022