Molecular Classifier for the Fine Needle-based Assessment of Malignancy Risk in Thyroid Nodules

NCT03392402 | Completed DMC

• 1 other identifier: 267398/4/NCBR/2015/1
• Study Type: observational
• Target: 599
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thyroid Nodule; Thyroid Neoplasm; Thyroid Cancer

Keywords

Thyroid nodule; Indeterminate thyroid nodule; Molecular biopsy; Gene expression classifier

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy in patients with indeterminate FNAB results who undergone surgery within 6 months from biopsy

  The improvement in accuracy of classification will be compared between sole clinical criteria (Bethesda class, tumor size, age, and sex) and combined classifier built on both clinical parameters and gene expression data. The population of indeterminate nodules will be defined by expert analysis of cytological samples by pathologists blinded to the outcome of surgery. Diagnostic accuracy will defined as the percentage of patients who were correctly diagnosed as benign or malignant based on the data available preoperatively.

  until surgery or 6 months from biopsy

Secondary Outcomes (1)

• Diagnostic accuracy in all patients recruited to the study, who were operated on or remained in follow-up for at least 24 months from biopsy.

  until surgery or 24 months from biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (above 18 years old) diagnosed with a thyroid nodule, in whom the fine-needle aspiration biopsy is undertaken to establish the necessity of thyroid surgery

You may qualify if:

• a diagnosis of thyroid nodule
• considerable chance for surgical procedure following biopsy result
• patient's consent for collection of material during routine fine needle aspiration biopsy

You may not qualify if:

• age below 18 years
• the presence of contraindications that make surgical treatment impossible
• prior diagnosis of thyroid cancer
• antithrombotic treatment except of acetylsalicylic acid or low molecular weight heparin at a prophylactic dose

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead

Study Sites (1)

Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Gliwice, 44-101, Poland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fine needle aspiration biopsy (FNAB) material and washout will be diluted in dedicated buffer and frozen in -80C. RNA and DNA will be isolated by commercial kits.

MeSH Terms

Conditions

Thyroid Nodule; Thyroid Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Barbara Jarzab, MD, PhD

  Maria Sklodowska-Curie National Research Institute of Oncology

  STUDY CHAIR

• Rafal Tarnawski, MD, PhD

  Maria Sklodowska-Curie National Research Institute of Oncology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 8, 2018
• Study Start: January 1, 2017
• Primary Completion: March 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 5, 2021

Record last verified: 2021-07

Locations

PL (1)