Ignite Creation Date:
2024-07-17 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471296
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-13
Brief Title:
Virus-associated Tumour Microenvironment
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Virus-associated Tumour Microenvironment Characterisation and Immunological Mechanisms of Resistance to Anti-tumour Treatments
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
VIRONMENT
Brief Summary:
The presence or absence of viruses affects the characteristics of cancer the response to anti-cancer treatments and the prognosis of the disease A cancerous tumor consists of cancerous cells as well as a variety of non-cancerous cells and molecules collectively known as the tumor microenvironment By studying these tumor microenvironments and understanding how our immune system interacts with virus-related and non-virus-related cancers investigators may discover new approaches to developing more effective anti-cancer treatments This study aims to characterize the tumor microenvironments specifically associated with viruses
This is a non-interventional ambispective multicentre study with 5 complementary workpackages WP WP1 clinic WP2 anatomopathology WP3 molecular analysis WP4 proteomic analyses using image-based mass cytometry on tissue sections coupled to the HYPERION imaging system and WP5 Bioinformatics and Biostatistics analyses Medical record data will be collected and used for this research The biological resources required for the study will be one or two additional blood samples of minimal volume or already available in the various tumour banks participating in the study Blood samples and archived biopsies will be transported to CIMI by private carrier Clinical data will be collected exclusively from the patients computerised medical record and entered into an electronic case report form e-CRF by the Clinical Study coordinator in each recruiting department identified by the investigating physicians
In the analysis investigators will initially compare the virus-associated and non-virus-associated groups by cancer type but investigators will also be able to set up a global test by stratifying on cancer type Investigators will use direct comparisons in the counts from the RNASeq analysis but also compositional analyses The remaining statistical evaluations will primarily focus on description and exploration and will be showcased accordingly These will involve conventional methods such as computing percentages means correlations along with survival analysis techniques like Kaplan-Meier and Cox regression
This is a non-interventional ambispective multicentre study with 5 complementary workpackages WP WP1 clinic WP2 anatomopathology WP3 molecular analysis WP4 proteomic analyses using image-based mass cytometry on tissue sections coupled to the HYPERION imaging system and WP5 Bioinformatics and Biostatistics analyses Medical record data will be collected and used for this research The biological resources required for the study will be one or two additional blood samples of minimal volume or already available in the various tumour banks participating in the study Blood samples and archived biopsies will be transported to CIMI by private carrier Clinical data will be collected exclusively from the patients computerised medical record and entered into an electronic case report form e-CRF by the Clinical Study coordinator in each recruiting department identified by the investigating physicians
In the analysis investigators will initially compare the virus-associated and non-virus-associated groups by cancer type but investigators will also be able to set up a global test by stratifying on cancer type Investigators will use direct comparisons in the counts from the RNASeq analysis but also compositional analyses The remaining statistical evaluations will primarily focus on description and exploration and will be showcased accordingly These will involve conventional methods such as computing percentages means correlations along with survival analysis techniques like Kaplan-Meier and Cox regression
Detailed Description:
After decades of cancer research targeting tumour cells strategies aimed at targeting the tumour microenvironment TME for therapeutic purposes are expanding rapidly It has been shown that the composition and quality of the TME have a major prognostic impact and influence the response to anti-tumour treatments such as immune checkpoint inhibitors ICIs and cytotoxic chemotherapies The immune mechanisms associated with the TME and involved in resistance to anti-tumour treatments have only been partially described and are currently leading to the development of promising new therapeutic approaches Virus-associated cancers are common and constitute a major public health problem Several viruses have been described as associated with cancers either directly involved in carcinogenesis oncoviruses eg Human Papilloma Virus HPV or indirectly by inducing for example immunodepression that favours the onset of cancer eg Human Immunodeficiency Virus HIV These viruses appear to be capable of affecting the molecular profile and the TME of these cancers thereby modifying their sensitivity to anti-tumour treatments Some of the TMEs associated with viruses have been partially described mainly using transcriptomic approaches and focusing on T lymphocytes The immune mechanisms specifically associated with viruses and involved in resistance to anti-tumour treatments such as ICIs and chemotherapy have not yet been described Characterising the TME and the immunomolecular mechanisms involved in resistance to anti-tumour treatments for both virus-associated and non-virus-associated cancers could reveal new molecular and immune targets These discoveries could form the basis of future therapeutic strategies targeting the TME of virus-associated cancers
This is a non-interventional ambispective multicentre study with 5 complementary workpackages WP WP1 clinic WP2 anatomopathology WP3 molecular analysis WP4 proteomic analyses using image-based mass cytometry on tissue sections coupled to the HYPERION imaging system and WP5 Bioinformatics and Biostatistics analyses A total of 254 subjects will be recruited prospectively and retrospectively over two and a half years within 17 recruiting clinical centre Five groups of patients will be recruited with matching on important clinical characteristics within the groups All the patients in the study will be patients followed up in the identified AP-HP clinical services for their cancer This is the prospective arm of the study patients with a de novo diagnosis of cancer will be recruited via consultations with the studys investigating physicians The investigating physicians will inform and obtain the non-opposition of the patients who take part in the research during a consultation
Clinical data will be collected exclusively from the patients computerised medical record and entered into an electronic case report form e-CRF by the Clinical Study Technicians in each recruiting department identified by the investigating physicians The e-CRF will be built by the Public Health Department of the Saint-Antoine Hospital within the Pierre Louis Institute of Epidemiology and Public Health INSERM UMR S 1136 under the responsibility of Prof Pierre-Yves BOELLE then validated by the study coordinatorsOmics data will be collected by the participating biological platforms and processed at the same site The biological resources required for the study will be one or two additional blood samples of minimal volume or already available in the various tumour banks participating in the study Blood samples and archived biopsies will be transported to CIMI by private carrier
In the analysis investigators will initially compare the virus-associated and non-virus-associated groups by cancer type but investigators will also be able to set up a global test by stratifying on cancer type investigators will use direct comparisons in the counts from the RNASeq analysis but also compositional analyses The remaining statistical evaluations will primarily focus on description and exploration and will be showcased accordingly These will involve
This is a non-interventional ambispective multicentre study with 5 complementary workpackages WP WP1 clinic WP2 anatomopathology WP3 molecular analysis WP4 proteomic analyses using image-based mass cytometry on tissue sections coupled to the HYPERION imaging system and WP5 Bioinformatics and Biostatistics analyses A total of 254 subjects will be recruited prospectively and retrospectively over two and a half years within 17 recruiting clinical centre Five groups of patients will be recruited with matching on important clinical characteristics within the groups All the patients in the study will be patients followed up in the identified AP-HP clinical services for their cancer This is the prospective arm of the study patients with a de novo diagnosis of cancer will be recruited via consultations with the studys investigating physicians The investigating physicians will inform and obtain the non-opposition of the patients who take part in the research during a consultation
Clinical data will be collected exclusively from the patients computerised medical record and entered into an electronic case report form e-CRF by the Clinical Study Technicians in each recruiting department identified by the investigating physicians The e-CRF will be built by the Public Health Department of the Saint-Antoine Hospital within the Pierre Louis Institute of Epidemiology and Public Health INSERM UMR S 1136 under the responsibility of Prof Pierre-Yves BOELLE then validated by the study coordinatorsOmics data will be collected by the participating biological platforms and processed at the same site The biological resources required for the study will be one or two additional blood samples of minimal volume or already available in the various tumour banks participating in the study Blood samples and archived biopsies will be transported to CIMI by private carrier
In the analysis investigators will initially compare the virus-associated and non-virus-associated groups by cancer type but investigators will also be able to set up a global test by stratifying on cancer type investigators will use direct comparisons in the counts from the RNASeq analysis but also compositional analyses The remaining statistical evaluations will primarily focus on description and exploration and will be showcased accordingly These will involve
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