Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633276
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
Fast and Accurate Breast Cancer Diagnosis Using Nanopore Sequencing in Tanzania Fast-ABCD Sequencing
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Nanopore Sequencing for Accelerating Breast Cancer Diagnosis in Tanzania a Prospective Observational Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot study will test the feasibility of using nanopore sequencing for breast cancer diagnosis in Tanzania It aims to show that nanopore sequencing is non-inferior to the current standard of care with the potential for faster and more cost-efficient results By enhancing the speed and accuracy of diagnosis this approach could improve treatment planning and outcomes for patients in resource-limited settings
Detailed Description:
Excess fresh tissue samples from patients with suspected breast cancer will undergo nanopore sequencing alongside the current standard of care SoC which includes histopathology and biomarker analysis for estrogen receptor progesterone receptor and human epidermal growth factor receptor 2 HER2 status
Low-pass whole genome sequencing and DNA methylation-based classification will potentially enable the diagnosis of invasive ductal breast cancer in a cost-efficient and highly accurate manner Additionally breast cancer subtypes can be determined using methylation signatures and HER2 focal amplification with results available within hours in a point-of-care setting
The primary outcome measures are non-inferiority compared to SoC turnaround time and overall feasibility Treatment is not altered due to results of the nanopore sequencing
Low-pass whole genome sequencing and DNA methylation-based classification will potentially enable the diagnosis of invasive ductal breast cancer in a cost-efficient and highly accurate manner Additionally breast cancer subtypes can be determined using methylation signatures and HER2 focal amplification with results available within hours in a point-of-care setting
The primary outcome measures are non-inferiority compared to SoC turnaround time and overall feasibility Treatment is not altered due to results of the nanopore sequencing
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?:
None
Is an FDA AA801 Violation?:
None