Concordance of Molecular Classification Based on Fine Needle Biopsy (FNB) and Surgical Samples

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The purpose of this study is to determine whether results from a fine needle biopsy are the same as results from a larger sample that is acquired from the surgical pathology using the Thyroid GuidePx® test in patients with papillary thyroid carcinoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• A diagnosis of papillary thyroid cancer based on a fine needle biopsy (FNB) interpreted as a Bethesda V or VI cytology

• A diagnosis of Atypia of Undetermined Significance (AUS) or Follicular Lesion of Undetermined Significance (FLUS) interpreted as Bethesda III or IV cytology (indeterminate nodule) ThyroSpec positive for BRAFV600E, TERT, rearrangements in BRAF, RET, NTRK1, NTRK3, RAS + TERT, RAS + EIF1AX, AKT1, PI3CA, CTNNB1, EGFR, rearrangements in ALK

• Tumor size \> 1 cm in maximal diameter on imaging prior to surgery

• The patient is an operative candidate

• The patient has provided consent

Locations
Other Locations
Canada
Foothills Medical Centre
RECRUITING
Calgary
Contact Information
Primary
Elleine Allapitan
elleine.allapitan@ucalgary.ca
403-220-8440
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2028-05
Participants
Target number of participants: 130
Sponsors
Collaborators: Alberta Health services, Qualisure Diagnostics Inc.
Leads: University of Calgary

This content was sourced from clinicaltrials.gov