Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625203
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
A Non-interventional International Multicentre Clinical Research Study to Build the Largest Collection of Multimodal Data Including Clinical Data Imaging Data and Omics Data in Oncology
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multi Omics and Spatial Atlas In Cancer
Status:
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:
MOSAIC
Brief Summary:
Cancer is amongst the leading causes of disease-related morbidity and mortality A major challenge in cancer treatment is the development of biology-informed personalised treatment strategies Recent advances in artificial intelligence AI and next-generation sequencing NGS technologies have shed further insights into disease biology and treatment pathways thus identifying new precision medicine-based therapeutic opportunities
The biological mechanisms leading to cancer development and progression arise from complex and plastic networks of dysregulated cellular programs involving many signalling pathways and effector molecules Cancer cells alter their surrounding environment via cell-cell interactions with non-tumor cells or by secreting cytokines chemokines and other factors This reprogramming of the tumour microenvironment TME is critical for cancer progression invasion and metastasis Moreover there are increasing studies that show that both innate and adaptive immune cell types contribute to tumorigenesis and treatment resistance when present within the TME Understanding the crosstalk between cancer cells and the surrounding TME will inform on mechanisms of sensitivity and resistance to treatment including immunotherapy IO and targeted therapies
Spatially resolved-Omics is an emerging field that characterises cell types by geneprotein expressions within their spatial context in the tissue organisation Recent high profile spatial transcriptomics studies have uncovered specific cell identities that define the surrounding TME
The MOSAIC study a collaborative initiative across industry and top oncology hospitals proposes to go way beyond current cancer molecular profiling projects by combining the generation and analysis of multiple data modalities 3 essential mandatory modalities Clinical Data Hematoxylin and Eosin HE microscopic image Spatial transcriptomics up to 3 high priority data modalities depending on technical feasibility and sample size bulk Ribonucleic Acid Sequencing RNAseq bulk Whole Exome Sequencing WES Single-cell transcriptomics and potentially other optional data modalities and follow-up experiments such as single-cell omics immunohistochemistry and spatial proteomics or other molecular profiling of proteins and molecules on a minimum of 2000 tumour samples across a different cancer indications This will generate broad molecular and cellular profiling data of the tumour and its microenvironment from cancer patients integrated with clinical data at an unprecedented scale and resolution
This study will enroll patients diagnosed with one of the eligible cancer indications and for which a formalin fixed paraffin embedded FFPE tumor sample from already performed biopsy andor surgical resection is available within their local pathology archive or their affiliate centers archives
The MOSAIC study expects to have a strong impact for patients in terms of new targeted therapeutic drug discovery identification of patient subgroups requiring either specific treatment or broader clinical care and identification of novel treatment response and resistance mechanisms
The biological mechanisms leading to cancer development and progression arise from complex and plastic networks of dysregulated cellular programs involving many signalling pathways and effector molecules Cancer cells alter their surrounding environment via cell-cell interactions with non-tumor cells or by secreting cytokines chemokines and other factors This reprogramming of the tumour microenvironment TME is critical for cancer progression invasion and metastasis Moreover there are increasing studies that show that both innate and adaptive immune cell types contribute to tumorigenesis and treatment resistance when present within the TME Understanding the crosstalk between cancer cells and the surrounding TME will inform on mechanisms of sensitivity and resistance to treatment including immunotherapy IO and targeted therapies
Spatially resolved-Omics is an emerging field that characterises cell types by geneprotein expressions within their spatial context in the tissue organisation Recent high profile spatial transcriptomics studies have uncovered specific cell identities that define the surrounding TME
The MOSAIC study a collaborative initiative across industry and top oncology hospitals proposes to go way beyond current cancer molecular profiling projects by combining the generation and analysis of multiple data modalities 3 essential mandatory modalities Clinical Data Hematoxylin and Eosin HE microscopic image Spatial transcriptomics up to 3 high priority data modalities depending on technical feasibility and sample size bulk Ribonucleic Acid Sequencing RNAseq bulk Whole Exome Sequencing WES Single-cell transcriptomics and potentially other optional data modalities and follow-up experiments such as single-cell omics immunohistochemistry and spatial proteomics or other molecular profiling of proteins and molecules on a minimum of 2000 tumour samples across a different cancer indications This will generate broad molecular and cellular profiling data of the tumour and its microenvironment from cancer patients integrated with clinical data at an unprecedented scale and resolution
This study will enroll patients diagnosed with one of the eligible cancer indications and for which a formalin fixed paraffin embedded FFPE tumor sample from already performed biopsy andor surgical resection is available within their local pathology archive or their affiliate centers archives
The MOSAIC study expects to have a strong impact for patients in terms of new targeted therapeutic drug discovery identification of patient subgroups requiring either specific treatment or broader clinical care and identification of novel treatment response and resistance mechanisms
Detailed Description:
None
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