Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409221
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-10
First Post:
2024-05-07
Brief Title:
VISION Triple Negative Breast Cancer Sample and Clinical Data Acquisition Study
Sponsor:
Concr
Organization:
Concr
Study Overview
Official Title:
VISION Defining Biomarkers of Chemotherapy Immunotherapy Response and Validation of the Breast Cancer Therapeutic Response Predictive Algorithm for Early Triple Negative Breast Cancers
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
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:
Background Despite improvements in the treatment of Triple Negative Breast Cancer TNBC the cancer returns in half of the women and shockingly 40 are dead within 5 years of their initial cancer diagnosis There is an urgent need to identify reliable biomarkers of response for chemotherapy and immunotherapy
Study Aims To update Concrs existing predictive algorithms specifically for use in women newly diagnosed with TNBC
The plan is develop technology which will predict which drug the cancer will respond best to treatment A vs treatment B AND how the individuals prognosis could change if treatment A is chosen overtreatment B
Study Design The VISION study is a clinical study looking back in time retrospective study specifically focusing on women who were previously diagnosed with early Triple Negative breast cancer and received chemotherapy followed by curative breast surgery The plan is to collect historical clinical data and previously collected cancer biopsy samples from up to 200 women in order to update Concrs existing treatment prediction algorithms Hence there are no extra research biopsies needed in order to participate in the Study
Study Sites UK and Australia
Study Funding This study is funded by the a Techbio company called Concr with support from Innovate UK UK Government funding
Study Aims To update Concrs existing predictive algorithms specifically for use in women newly diagnosed with TNBC
The plan is develop technology which will predict which drug the cancer will respond best to treatment A vs treatment B AND how the individuals prognosis could change if treatment A is chosen overtreatment B
Study Design The VISION study is a clinical study looking back in time retrospective study specifically focusing on women who were previously diagnosed with early Triple Negative breast cancer and received chemotherapy followed by curative breast surgery The plan is to collect historical clinical data and previously collected cancer biopsy samples from up to 200 women in order to update Concrs existing treatment prediction algorithms Hence there are no extra research biopsies needed in order to participate in the Study
Study Sites UK and Australia
Study Funding This study is funded by the a Techbio company called Concr with support from Innovate UK UK Government funding
Detailed Description:
VISION is a commercially sponsored clinical trial designed to be a retrospective observational non-CTIMP research study which will collect archival tumour samples from participants previously treated with chemotherapy - immunotherapy for early Triple Negative Breast Cancer TNBC
Current Study design
VISION currently has 2 retrospective patient cohorts
1 Arm A Patients treated with neoadjuvant chemotherapy who had a complete pathological response n 100
2 Arm B Patients treated with neoadjuvant chemotherapy who had a residual cancer burden n100
Planned study design Include a prospective arm Arm C to test feasibility of generating treatment predictions in real time
Study sites UK and Australia
Study timelines 2 years UK start date April 26th 2024
Datasets planned for collection are
1 Clinical data about the individual cancer stage at diagnosis cancer treatment treatment response and clinical outcome
2 Genomic data from diagnostic breast cancer samples - surgical samples
3 Whole Slide Imaging data from tumour sections
Planned Next Generation Sequencing of tumours
1 RNA sequencing
2 DNA sequencing
3 Other NGS approaches or -OMICS subject to tissue availability
Planned tissue collection
Tissue type Archival FFPE samples Diagnostic samples before chemotherapy - surgical samples after chemotherapy
Planned technology development
Existing Concr technology which predicts cancer response currently pan-cancer in the early Triple Negative Breast Cancer population A key objective is to demonstrate that accurate prediction of therapeutic response for chemotherapy specifically anthracyclines taxanes platinums anti-metabolites withwithout immunotherapy
Current Study design
VISION currently has 2 retrospective patient cohorts
1 Arm A Patients treated with neoadjuvant chemotherapy who had a complete pathological response n 100
2 Arm B Patients treated with neoadjuvant chemotherapy who had a residual cancer burden n100
Planned study design Include a prospective arm Arm C to test feasibility of generating treatment predictions in real time
Study sites UK and Australia
Study timelines 2 years UK start date April 26th 2024
Datasets planned for collection are
1 Clinical data about the individual cancer stage at diagnosis cancer treatment treatment response and clinical outcome
2 Genomic data from diagnostic breast cancer samples - surgical samples
3 Whole Slide Imaging data from tumour sections
Planned Next Generation Sequencing of tumours
1 RNA sequencing
2 DNA sequencing
3 Other NGS approaches or -OMICS subject to tissue availability
Planned tissue collection
Tissue type Archival FFPE samples Diagnostic samples before chemotherapy - surgical samples after chemotherapy
Planned technology development
Existing Concr technology which predicts cancer response currently pan-cancer in the early Triple Negative Breast Cancer population A key objective is to demonstrate that accurate prediction of therapeutic response for chemotherapy specifically anthracyclines taxanes platinums anti-metabolites withwithout immunotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None