Clinical Trials Logo

Clinical Trial Summary

This study evaluates the usefulness of molecular classifier to aid the diagnosis of malignancy in the material obtained by fine-needle aspiration biopsy (FNAB) of thyroid nodule. All participants will undergo FNAB with routine cytological assessment and molecular testing. Patients will undergo surgery or be followed-up, according to the clinical guidelines. The diagnostic power of combined molecular/clinical classifier will be compared to prediction based on clinical features only, by investigators blinded to the final diagnosis of surgical assessment.


Clinical Trial Description

Currently, the diagnosis of malignancy of thyroid nodule is based on cytological assessment of fine-needle aspiration biopsy (FNAB) classified according to the Bethesda System for Reporting of Thyroid Cytopathology. This does not allow for the definitive diagnosis of cancer in significant proportion of tumors, so called indeterminate nodules (Bethesda class III, IV and V). These patients require surgery to establish a definitive diagnosis, leading to unnecessary operating procedures in at least 2/3 of subjects. Molecular classifiers could significantly improve thyroid preoperative diagnostics, although they are not optimal and provide either high specificity to the detriment of low sensitivity or conversely, relatively low specificity with high sensitivity. The classifiers could be based on gene expression or mutations present in FNAB specimen. In the present study the investigators plan to assess the improvement of classification power by molecular gene-expression-based multi-feature classifier when added to standard clinical parameters indicating the risk of malignancy (Bethesda class, tumor size, patient age and sex). Participants will undergo FNAB with prospective collection of material for molecular testing and simultaneous preoperative recording of all clinical parameters. The patients will be operated on or followed-up according to the clinical guidelines. The comparison of a predictive power of clinical criteria to the combined clinical-molecular classifier will be carried out by the group of investigators blinded to the results of final surgery. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03392402
Study type Observational
Source Maria Sklodowska-Curie Institute - Oncology Center
Contact
Status Completed
Phase
Start date January 1, 2017
Completion date December 31, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT05774535 - Prospective, Observational Study on the Carotid Intima-media Thickness in Patients Undergoing Thyroid Surgery
Withdrawn NCT04224792 - Effects of Exercise Training on Fatigue in Thyroid Cancer Survivors N/A
Completed NCT01728623 - A Study of E7080 in Subjects With Advanced Thyroid Cancer Phase 2
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Completed NCT02911155 - Cancer and Other Disease Risks in U.S. Nuclear Medicine Technologists
Recruiting NCT05025046 - NGS-based Thyroscan Genomic Classifier in the Diagnosis of Thyroid Nodules
Not yet recruiting NCT03978351 - The Role of Midkine in Diagnosis of Thyroid Cancer
Completed NCT02658513 - Evaluation of Lancet Blood Sampling for Radioiodine Dosimetry in Thyroid Cancer
Terminated NCT02628535 - Safety Study of MGD009 in B7-H3-expressing Tumors Phase 1
Completed NCT02375451 - Effect of Childhood Radioiodine Therapy on Salivary Function N/A
Withdrawn NCT01994200 - Developing and Implementing an Interdisciplinary Team-Based Care Approach (ITCA-ThyCa) for Thyroid Cancer Patients Phase 1/Phase 2
Terminated NCT01403324 - Comparison of Dosimetry After rhTSH or Withdrawal of Thyroid Hormone in Metastatic or Locally Advanced Thyroid Cancer N/A
Completed NCT00970359 - Reacquisition of Radioactive Iodine (RAI) Uptake of RAI-Refractory Metastatic Thyroid Cancers by Pretreatment With the Selective MEK Inhibitor AZD6244 N/A
Completed NCT00439478 - Dental Safety Profile of High-Dose Radioiodine Therapy Phase 4
Completed NCT00223158 - Evaluation Study of L-T3 Utility in the Follow-up of Patients With Thyroid Cancer N/A
Active, not recruiting NCT04544111 - PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer Phase 2
Completed NCT04876287 - Salivary dysfuncTion After Radioiodine Treatment
Recruiting NCT06073223 - Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer N/A
Recruiting NCT06037174 - Comparison of Quality of Life in Patients With Differentiated Thyroid Carcinoma Undergoing Different Surgery
Recruiting NCT04952493 - Anlotinib or Penpulimab in Combination With RAI for DTC Phase 2