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Trial Title:
Concordance of Molecular Classification Based on Fine Needle Biopsy (FNB) and Surgical Samples
NCT ID:
NCT06133374
Condition:
Papillary Thyroid Cancer
Conditions: Official terms:
Thyroid Cancer, Papillary
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
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 doctor's 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.
Criteria for eligibility:
Study pop:
Patients with a preoperative tissue diagnosis of PTC (Bethesda VI) or suspicious for PTC
(Bethesda V) eligible for partial or total thyroidectomy
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Age ≥ 18 years
- A diagnosis of papillary thyroid cancer based on a fine needle biopsy (FNB)
interpreted as a Bethesda V or VI cytology
- Tumor size > 1 cm in maximal diameter
- The patient is an operative candidate
- The patient has provided consent
Exclusion Criteria:
- Family history of thyroid cancer
- History of radiation to the neck
- Unable or unwilling to have a fine needle biopsy
- Unwilling to undergo thyroidectomy
- Final pathology does not demonstrate papillary thyroid cancer
- Cases where there is no clear dominant nodule
- Cases where there are multiple nodules that preclude sampling of a defined nodule
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Foothills Medical Centre
Address:
City:
Calgary
Zip:
T2N 1N4
Country:
Canada
Contact:
Last name:
Elleine Allapitan
Phone:
4032208440
Investigator:
Last name:
Adrian Harvey, MD
Email:
Sub-Investigator
Investigator:
Last name:
Janice Pasieka, MD
Email:
Sub-Investigator
Investigator:
Last name:
Shamir Chandarana, MD
Email:
Sub-Investigator
Investigator:
Last name:
Robert Hart, MD
Email:
Sub-Investigator
Investigator:
Last name:
Wayne Matthews, MD
Email:
Sub-Investigator
Investigator:
Last name:
Martin Hyrcza, MD/PhD
Email:
Sub-Investigator
Investigator:
Last name:
Moosa Khalil, MD
Email:
Sub-Investigator
Investigator:
Last name:
Anthony Magliocco, MD
Email:
Sub-Investigator
Investigator:
Last name:
Karen Kopciuk, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Tasnima Abedin, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Faisal Khan, PhD
Email:
Sub-Investigator
Start date:
June 2024
Completion date:
May 2028
Lead sponsor:
Agency:
University of Calgary
Agency class:
Other
Collaborator:
Agency:
Qualisure Diagnostics Inc.
Agency class:
Other
Collaborator:
Agency:
Alberta Health services
Agency class:
Other
Source:
University of Calgary
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06133374
