ClinicalTrials.gg
RecruitingNCT06471296VIRONMENTUpdated Sep 10, 2026

Virus-associated Tumour Microenvironment

An observational study in Lymphoma, Cancers of the Lung and Cancer Anal Canal, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

From the registry’s dates

  • Started May 2026; still recruiting 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 100 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Lymphoma by Assistance Publique - Hôpitaux de Paris — 2 open to participants now, 4 under way, none of them phase 3. Lymphoma · Assistance Publique - Hôpitaux de Paris.

Started
2026
with 1 other
Observational
6 of 11
2 open now
Registered
11th of 11
by date

Among the 11 studies in Lymphoma by Assistance Publique - Hôpitaux de Paris, this one is one of 2 that started in 2026, is one of 6 observational ones, and was the 11th registered.

By phase

11 studies; the count open now beside each. This study's row is marked.

Observationalthis study6 · 2 open
No phase1 · 0 open
Phase 1/21 · 0 open
Phase 21 · 0 open
Phase 2/31 · 0 open
Phase 31 · 0 open

By the year they started

First in 2004; this study’s year is marked. 2 started in 2026.

Size and results

Median enrollment 92 across the 5 interventional studies, 330 across the 5 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 11 studies in Lymphoma by Assistance Publique - Hôpitaux de Paris, or all of them as a file.
02

Study 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.

Read the 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, e.g. Human Papilloma Virus (HPV)) or indirectly by inducing, for example, immunodepression that favours the onset of cancer (e.g. 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 study's 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 patient's 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 coordinators.Omics 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

03

Conditions studied

  • Lymphoma
  • Cancers of the Lung
  • Cancer Anal Canal

Keywords

  • Virus
  • tumor microenvironement
  • chemotherapy
  • immunotherapy
04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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).
  • -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 (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 ( 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.
  • to participate signed before any specific study procedure is carried out.

Exclusion criteria

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 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: treatment ( \<10mg prednisone equivalent per day authorised).
  • Adults under guardianship or curatorship.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No
06

What researchers measure

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.

    Time frame: 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.

    Changes in the cellular and molecular composition of the tumour microenvironment with resistance under systemic antitumour treatment compared with the diagnosis, analysed using: * transcriptomic (RNAseq) approache. * PROTEOMIC (mass cytometry on tissue sections coupled with the HYPERION imaging system) approache.

    Time frame: Through study time period, 3 years and half

07

Study locations

1 of 1 sites recruiting
  • Service d'ORL - Oto-Rhino-Laryngologie et chirurgie cervico faciale, Hôpital Bichat - Claude-Bernard
    Paris, 75018, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

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

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06471296
Responsible party
Sponsor
First posted
Jun 24, 2024
Start date
May 5, 2026
Primary completion
Nov 5, 2029 (estimated)
Completion
Nov 5, 2029 (estimated)
Last update
Sep 10, 2026

Study contacts

PHILIPPE SPANO
Contact
jean-philippe@aphp.fr
01 42 16 04 72

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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