ctDNA in Patients With Thyroid Nodules

Learn more about:
Related Clinical Trial
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

ctDNA in Patients With Thyroid Nodules

Official Title

Determination of the Utility of Plasma Circulating Tumor DNA (ctDNA) Measurements for Detection of Thyroid Cancer in Patients Undergoing Diagnostic Fine Needle Aspirations of the Thyroid

Brief Summary

      When the DNA inside of human cells undergoes certain alterations (mutations), the cells may
      develop into a cancer. The cancer cells may shed this DNA into the blood stream. This
      circulating tumor DNA (ctDNA) can be detected by very sensitive, specialized laboratory
      tests. Measurement of ctDNA has been shown to be useful for following patients with known
      cancer. The purpose of this study is to examine blood specimens for the presence of ctDNA in
      individuals without known cancer who are scheduled to undergo a fine needle aspiration biopsy
      of the thyroid gland because of one or more thyroid nodules in order to see if the ctDNA test
      can detect a cancer at a very early stage. The results of this study should help define the
      role of ctDNA in the detection of early stage thyroid cancer and to define how sensitive it
      is (i.e. how well it picks up cancer when it is present) and how specific it is (i.e. how
      often is ctDNA found in patients with benign thyroid nodules).

Detailed Description

      After the participants with thyroid nodules or other abnormalities have undergone the
      informed consent process, they will have 30 milliliters (approximately two tablespoons) of
      blood drawn. This will be done prior to the performance of the fine needle aspiration biopsy
      of the thyroid. If the patient has indicated a desire to receive the results of their test,
      they will receive a written description, as will their physician. The patients will be
      contacted yearly for up to 5 years by the study staff to learn whether they have been found
      to have a diagnosis of thyroid or other cancer.

Study Type


Primary Outcome

Utility of plasma ctDNA measurements to detect thyroid cancer

Secondary Outcome

 Determination of incident rate of new thyroid or other cancers in patients who underwent initial measurement of ctDNA.


Thyroid Cancer


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

Recruitment Information

Estimated Enrollment


Start Date

May 2016

Completion Date

August 2017

Primary Completion Date

August 2017

Eligibility Criteria

        Inclusion Criteria:

          -  18 years of age or older;

          -  presence of one or more thyroid nodules who are going to have a fine needle aspiration
             biopsy performed as part of their normal care.

        Exclusion Criteria:

          -  Prior history of cancer excluding basal cell carcinoma of the skin.




18 Years - N/A

Accepts Healthy Volunteers



Glenn D. Braunstein, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID

Pathway Genomics-007

Responsible Party


Study Sponsor

Pathway Genomics

Study Sponsor

Glenn D. Braunstein, M.D., Principal Investigator, Pathway Genomics

Verification Date

August 2017