Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06133374
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2023-11-10
Brief Title:
Concordance of Molecular Classification Based on Fine Needle Biopsy FNB and Surgical Samples
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Concordance of Molecular Classification Based on Fine Needle Biopsy FNB and Surgical Samples
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Thyroid cancer is the 8th most common cancer and incidence has been increasing Papillary thyroid carcinoma PTC accounts for most thyroid cancers Treatment decisions related to PTC depend on the doctors estimate on whether the cancer is aggressive or not Current methods for distinguishing aggressive tumors from less aggressive tumors rely on clinical factors as well as factors related to the final pathology after the tumor has been removed Ideally the information required to make decisions would be available prior to surgery so that surgical decisions can be made
A new test is being developed to determine molecular features of a PTC and to estimate the risk of cancer recurrence after surgery Thyroid GuidePx provides unique information that may inform doctors decisions The greatest potential for Thyroid GuidePx to impact on clinical care is if it can be performed prior to surgery on a fine needle biopsy FNB If Thyroid GuidePx could be done on an FNB it would inform surgeons on the type of surgery that would be most appropriate for an individual
A recent feasibility study consisting of 12 patients with PTC demonstrated that performing the Thyroid GuidePx assay on FNBs is feasible However reliance on a limited FNB for molecular disease characterization implies that the sample is representative of the entirety of the tumor Genomic and transcriptomic heterogeneity has been described in primary tumors and metastases Therefore it will be important to document the concordance between samples acquired by FNB and surgical samples The goal of this study is to determine whether the more limited sample from an FNB is sufficiently representative of the larger tumor to determine a valid molecular classification using the Thyroid GuidePx test in patients with PTC
Participants will be invited to participate if they have a preoperative tissue diagnosis of PTC Bethesda VI or suspicious for PTC Bethesda V and they are eligible for partial or total thyroidectomy During surgery when the thyroid gland and the tumor are exposed the surgeon will perform an FNB of the dominant tumor ie the lesion identified preoperatively under direct vision The cellular material from the FNB will be sent for processing Separate surgical samples will be processed and examined This will follow routine specimen processing protocols and will not interfere with standard methods of pathologic diagnosis Tissue will be released for research only once sufficient tissue is taken for diagnostic and clinical use RNASeq for Thyroid GuidePx for both FNB and surgical samples will be performed and compared
A new test is being developed to determine molecular features of a PTC and to estimate the risk of cancer recurrence after surgery Thyroid GuidePx provides unique information that may inform doctors decisions The greatest potential for Thyroid GuidePx to impact on clinical care is if it can be performed prior to surgery on a fine needle biopsy FNB If Thyroid GuidePx could be done on an FNB it would inform surgeons on the type of surgery that would be most appropriate for an individual
A recent feasibility study consisting of 12 patients with PTC demonstrated that performing the Thyroid GuidePx assay on FNBs is feasible However reliance on a limited FNB for molecular disease characterization implies that the sample is representative of the entirety of the tumor Genomic and transcriptomic heterogeneity has been described in primary tumors and metastases Therefore it will be important to document the concordance between samples acquired by FNB and surgical samples The goal of this study is to determine whether the more limited sample from an FNB is sufficiently representative of the larger tumor to determine a valid molecular classification using the Thyroid GuidePx test in patients with PTC
Participants will be invited to participate if they have a preoperative tissue diagnosis of PTC Bethesda VI or suspicious for PTC Bethesda V and they are eligible for partial or total thyroidectomy During surgery when the thyroid gland and the tumor are exposed the surgeon will perform an FNB of the dominant tumor ie the lesion identified preoperatively under direct vision The cellular material from the FNB will be sent for processing Separate surgical samples will be processed and examined This will follow routine specimen processing protocols and will not interfere with standard methods of pathologic diagnosis Tissue will be released for research only once sufficient tissue is taken for diagnostic and clinical use RNASeq for Thyroid GuidePx for both FNB and surgical samples will be performed and compared
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None