Virus-associated Tumour Microenvironment

NCT06471296 | Not Yet Recruiting

• 1 other identifier: APHP241217
• Study Type: observational
• Target: 254
• Locations: 0 countries
• Sites: N/A

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 patient's 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.

Conditions

Lymphoma; Cancers of the Lung; Cancer Anal Canal

Keywords

Virus; tumor microenvironement; chemotherapy; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Cellular and molecular composition of the tumour microenvironment at diagnosis

  Cellular and molecular composition of the tumour microenvironment at diagnosis, analysed using: * transcriptomic (RNAseq) approache * proteomic (mass cytometry on tissue sections coupled with the HYPERION imaging system) approache.

  Through study time period, 3 years and half

Secondary Outcomes (1)

• Changes in the cellular and molecular composition of the tumour microenvironment with resistance under systemic antitumour treatment compared with the diagnosis.

  Through study time period, 3 years and half

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People followed up for cancers (lymphomas, cancers of the lung, oropharynx and anal canal).

You may qualify if:

• Patients followed in one of the following AP-HP clinical departments: Medical oncology - Pitié-Salpêtrière, Clinical haematology - Pitié-Salpêtrière, Hepato-Gastroenterology - Pitié-Salpêtrière, Maxillo-facial surgery - Pitié-Salpêtrière, Radiation oncology - Pitié-Salpêtrière, Pneumology - Tenon, Medical oncology - Tenon, Radiation oncology - Tenon, Medical oncology - Saint-Antoine, Clinical haematology - Saint-Antoine, Pneumology - Bichat, ENT and cervico-facial surgery - Bichat, Pneumology - Cochin, Medical Oncology - HEGP, Medical Oncology - Saint Louis, Pneumology - Ambroise Paré, Medical Oncology - Avicennes
• Histologically confirmed diagnosis of :
• HPV-related squamous cell carcinoma of the oropharynx (positive HPV PCR).
• Non-HPV-related squamous cell carcinoma of the oropharynx (negative HPV PCR).
• HIV-associated non-small cell lung cancer (NSCLC) (positive HIV serology).
• HPV-related NSCLC (malignant transformation of recurrent respiratory papillomatosis with positive HPV PCR).
• NSCLC neither HPV-related (negative HPV PCR) nor HIV-associated (negative HIV serology).
• Large-cell B lymphoma (diffuse large-cell NOS B lymphoma, high-grade B lymphoma, primary B lymphoma of the central nervous system):
• Post-transplant lymphoma (PTL) linked or not to Epstein-Barr virus (EBV)(EBER positive or negative on tumour tissue).
• Associated with HIV (positive HIV serology) and EBV-related or not (positive or negative EBER on tumour tissue).
• Associated with neither HIV nor EBV (negative HIV serology, negative EBER on negative tumour tissue).
• HPV-related squamous cell carcinoma of the anal canal (positive HPV PCR) and associated with HIV (positive HIV serology).
• HPV-related squamous cell carcinoma of the anal canal (positive HPV PCR) not associated with HIV (negative HIV serology).
• Patients in the virus-associated cancers VS non-virus-associated cancers groups will be matched on important clinical features within the groups:
• Oropharyngeal squamous cell carcinoma: tumour stage (I/II or III/IV according to 8th TNM (85)), smoking status (smoker or non-smoker) and systemic anti-tumour treatment planned or received (cytotoxic chemotherapy or Immune checkpoint inhibitors (ICI)(anti PD1) or cytotoxic chemotherapy and ICI(anti PD1)).

You may not qualify if:

• Cancers other than those included in the study.
• For NHL: plasmablastic lymphoma, polymorphic lymphoma, follicular lymphoma, mantle cell lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma, unknown tumour EBV status, unknown HIV status.
• For lung cancers: NSCLC with histology other than adenocarcinoma or squamous cell carcinoma, small cell lung cancer, EGFR mutation, ALK rearrangement.
• Absence of tumour material dating from before the start of systemic anti-tumour treatments.
• For oropharynx, NSCLC and anal canal: tumour material not from the tumour's organ of origin.
• Tumour material of interest exhausted: insufficient for the analyses planned in the study.
• For the anal canal, oropharynx and NSCLC cohorts: immunosuppressive treatment (corticosteroids \<10mg prednisone equivalent per day authorised).
• Adults under guardianship or curatorship.
• Refusal to take part in the study

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Lymphoma; Virus Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Infections

Central Study Contacts

PHILIPPE SPANO

CONTACT

01 42 16 04 72; jean-philippe@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 24, 2024
• Study Start: September 2, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal