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Clinical trial Recruiting at 1 site Observational Ages 18 to 100

Virus-linked Tumor Microenvironment in CancerPatients

Official title: Virus-associated Tumour Microenvironment: Characterisation and Immunological Mechanisms of Resistance to Anti-tumour Treatments

Run by Assistance Publique - Hôpitaux de Paris · NCT06471296 · Data updated 2026-11-12

This study tests how viruses influence the tumor environment across several cancers to understand how Treatments might work better.

Quick facts

Study typeObservational
Ages18 Years to 100 Years
SexAll
Enrollment150 (estimated)
SponsorAssistance Publique - Hôpitaux de Paris
Academic / other
Drugs / interventionschemotherapy, prednisone
Locations1 site (Paris)
StatusRecruiting
StartedMay 5, 2026
Main results expectedNovember 5, 2029
Study endsNovember 5, 2029
Registry record updatedSeptember 10, 2026
Trial IDNCT06471296 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with confirmed HPV-related or non-HPV-related or HIV-associated cancers within the listed conditions and treated at AP-HP sites.

Probably not a fit

Patients whose tumors show no viral association or whose data do not reveal actionable patterns may derive no direct benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, multicenter study that will look at tumor tissues and patient records to understand how viruses shape the tumor microenvironment in cancers such as lymphoma and lung/anal canal cancers. It includes five work packages covering clinical data, pathology analyses, molecular and proteomic studies, and bioinformatics. The goal is to see how viral presence or absence correlates with immune responses and treatment sensitivity, especially to immunotherapies and chemotherapy. Results may guide future strategies to tailor treatments based on viral associations in the tumor environment.

Why it matters

Potential benefit: Findings could help doctors predict which patients may respond better to certain therapies based on their tumor’s viral characteristics.

How similar studies have gone: Prior research suggests the tumor microenvironment varies with viral status, but comprehensive, multi-omics correlation in this context is still emerging.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Patients followed in one of the following AP-HP clinical departments
* Confirmed histological 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)).
* NSCLC: histology (squamous cell carcinoma or adenocarcinoma), 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 (ICI (anti PD1) or cytotoxic chemotherapy and ICI (anti PD1)).
* NHL: patients will be matched 2:2 (LPT EBV+ vs EBV- and HIV+ EBV+ vs EBV-) on location (systemic vs brain), performans status (PS 0-1 vs 2-4) for brain lymphomas, and age-adjusted IPI score (LDH, performans status, stage: 0-1 vs 2-3) for systemic lymphomas.
* Squamous cell carcinoma of the anal canal: tumour stage (I/II or III/IV according to 8th TNM (85)), and anti-tumour treatment planned or received (cytotoxic chemotherapy or cytotoxic chemotherapy and radiotherapy).

For the analysis of the characteristics of the MET at diagnosis: tumour material (biopsy or surgical specimen) available dating from before the introduction of anti-cancer treatments. This tumour material must come from the tumour's organ of origin for patients in the oropharynx, NSCLC and anal canal cohorts.

* For the analysis of mechanisms of resistance to systemic anti-tumour treatments: tumour material (biopsy or surgical specimen) available from before the introduction of anti-cancer treatments and tumour material (biopsy or surgical specimen) taken after tumour progression under treatment and before the introduction of a new systemic anti-tumour treatment. This tumour material must come from the tumour's organ of origin for patients in the oropharynx, NSCLC and anal canal cohorts.
* Cancer that has undergone or is due to undergo excision surgery or biopsy.
* Informed consent to participate signed before any specific study procedure is carried out.

Exclusion Criteria:

* 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.
* 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.

Where it's running

  • Service d'ORL - Oto-Rhino-Laryngologie et chirurgie cervico faciale, Hôpital Bichat - Claude-Bernard
    Paris, France     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.