Non Hodgkin LymphomaIDeATIonNCT03706625
Integrated Discovery of New Immuno-Molecular Actionable Biomarkers for Tumors With Immune-suppressed Environment
An observational study of Non Hodgkin Lymphoma and Non Small Cell Lung Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The explosion of novel therapies targeting tumor mutations or immune molecules requests to define or better characterize the mutational profiles of tumors that are none or insufficiently explored so far. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Hodgkin Lymphoma, Non Small Cell Lung Cancer, Glioma
- How many people
- 201 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2018to 6 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients followed-up at Pitié-Salpêtrière hospital, Tenon hospital, Henri Mondor hospital, Saint-Louis hospital or intercommunal hospital center of Créteil with histological diagnosis of HIV-related non-small cell lung cancer, immunocompetent non-small cell lung cancer, HIV-related Non-Hodgkin-Lymphomas (NHL), immunocompetent NHL, post-transplant NHL, primary lymphoma of the central nervous system, glioma.
Who may be able to join
- Age ≥ 18 years.
- Followed at Pitié-Salpêtrière hospital, Tenon hospital, Henri Mondor hospital, Saint-Louis hospital or intercommunal hospital center of Créteil
- Histological diagnosis confirmed of:
- Non-small cell lung cancer (adenocarcinoma, squamous cell, large cells) related to HIV, or
- Immunocompetent non-small cell lung cancer (adenocarcinoma, squamous cell, large cells), or
- Non-Hodgkin's lymphoma (NHL): HIV-related NHL, post-transplant lymphoproliferation (LPT) according to WHO (World Health Organization) 2016 classification, primary CNS (central nervous system) lymphoma (LPS), or
Show all 15Show fewer
- Primary CNS lymphoma
- Immunocompetent NHL: diffuse large B cell lymphoma (ABC or GC)
- Glioma
- Naïve cancer treatment (except for the specific case of gliomas with certain or possible activation of MAPK (Mitogen-activated protein kinases) and MMR (Mismatch Repair) inactivation).
- Cancer undergoing surgery for excision or a large biopsy (pleural biopsy under video-thoracoscopy, mediastinoscopy, biopsy lymph node excision or cutaneous or cerebral metastasis).
- For patients with NSCLC: hemoglobin level> 9 g / dL; for patients with NHL or glioma: hemoglobin > 7 g / dL.
- Weight ≥ 48 kg.
- Informed consent to participation signed before carrying out any specific procedure of the study.
- Affiliation to the French social security system.
Who cannot join
- Other cancer than those in the study:
- For NHL after transplantation: marginal zone NHL, follicular NHL, mantle cell NHL, lymphoplasmocytic NHL (non-WHO lymphoma as LPT)
- For HIV-related LPTs and NHLs: LPS
- For LPT: tumor EBV status unknown
- For immunocompetent NHL: other NHL than diffuse large B cell lymphoma
- For lung cancers: small cell lung cancer
- Absence of tumor material, blood or saliva samples taken before the start of chemotherapy (except for the specific case of gliomas with certain or possible activation of MAPK and MMR inactivation)
- Major under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
The explosion of novel therapies targeting tumor mutations or immune molecules requests to define or better characterize the mutational profiles of tumors that are none or insufficiently explored so far. This is particularly the case for tumors arising in immune-suppressed individuals or environments which have been poorly, if any, analyzed so far with modern molecular methods. The goal of the translational research program, Ideation, is to define novel biomarkers such as the tumor mutational profiling and immunomutanome in such contexts and to compare the results obtained to those observed in immune competent individuals. In addition, this approach will allow to characterize novel key non-invasive diagnostic and prognostic biomarkers such as circulating tumoral DNA and cells. Altogether results will provide novel biomarkers to better adapt therapeutic strategies in these cancers, to monitor response to treatment as well as to define new molecular targets of potential therapeutic strategies.
Read the detailed description
The main objective is to discover novel invasive and non-invasive immuno-molecular actionable biomarkers in rare but severe tumors arising in immune-suppressed compared for some tumors in immune-competent patients. Indeed, this tumors present a deficient immune environment, either due to the host acquired immune deficiency, i.e. transplantations or HIV infection, or because the diseased tissue belongs in an immune sanctuary as the brain. The primary hypothesis, in this context, is that these tumor mutational profiles and their changes during drug therapy must be influenced by the immune environment and response. This must lead to differences from similar tumors observed in immune-competent environments (immunocompetent individuals or tissues expressing immunity), responsible for: modification in the molecular targets for appropriate drugs ; alteration of tumor immunogenicity and of future immune-based therapies ; specific biomarkers for monitoring the response to drug therapy. The objectives of this program are to carry on invasive and non-invasive investigations in order to define the mutational profile of these free types of severe tumors, non-Hodgkin lymphoma (NHL), lung cancers and gliomas arising in hosts or tissues with altered immunity. These investigations will lead to : identify novel invasive and non-invasive biomarkers for predicting and evaluating efficacy of future personalized and immune-based therapies; compare tumors from immune-suppressed and immune-competent hosts; discover hot spots of tumoral mutations as mechanisms of tumors resistance, new molecular targets for future molecular and immune-bases therapeutic strategies; define the tumor immunomutanome as a score of neo-epitopes predicting: tumor immunogenicity, disease outcome and efficacy of immunotherapies; detect non-invasive tumoral biomarkers from liquid biopsies based on Circulating tumoral DNA and Circulating tumoral Cells to facilitate future diagnosis and monitoring of such tumors; identify biomarkers of tumor escape or resistance to treatments.
- Conditions
- Non Hodgkin Lymphoma, Non Small Cell Lung Cancer, Glioma
- Keywords
- Non Hodgkin Lymphoma, glioma, lung cancer, HIV, transplantation, brain
- Medical subject headings
- Lymphoma, Non-Hodgkin, Carcinoma, Non-Small-Cell Lung, Glioma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-Hodgkin-Lymphoma (after transplantation) | Immune-suppressed patients suffering from Non-Hodgkin-Lymphoma (after transplantation) and followed in the four centers of reference for rare cancers (KVirogref, CANCERVIH, LOC and POLA) | |
| Non-small cell lung cancer | Immune-suppressed patients suffering from HIV-related non-small cell lung cancer, followed in the four centers of reference for rare cancers (KVirogref, CANCERVIH, LOC and POLA) | |
| Primary Central Nervous System Lymphoma | Patients suffering from primitive cerebral lymphomas and followed in the four centers of reference for rare cancers (KVirogref, CANCERVIH, LOC and POLA) | |
| Gliomas | Patients suffering from Gliomas and followed in the four centers of reference for rare cancers (KVirogref, CANCERVIH, LOC and POLA) | |
| Non-Hodgkin-Lymphoma with HIV infection | Immune-suppressed patients (during HIV infection) and followed in the four centers of reference for rare cancers (KVirogref, CANCERVIH, LOC and POLA) | |
| Immunocompetent Non-Hodgkin-Lymphoma | Immunocompetent patients and followed in the four centers of reference for rare cancers (KVirogref, CANCERVIH, LOC and POLA). | |
| Immunocompetent Non-small cell lung cancer | Immunocompetent patients suffering from non-small cell lung cancer and followed in the four centers of reference for rare cancers (KVirogref, CANCERVIH, LOC and POLA). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic value of the tumor invasive biomarkers
Analyze of the tumor biomarkers on frozen biopsy for the three types of cancer (NHL, lung cancer and glioma)
Measured: at Day 0
Secondary outcomes (3)
Determination of tumoral biomarkers
- the mutational tumor profile by using a next generation sequencing (NGS) comparingson of the tumor DNAgenome with the patient's constitutional genome (sequenced on blood or saliva) for the three types of cancer (NHL, lung cancer and glioma) and ii) immunomutanome and score of neo-epitopes defined by tumor RNA-sequencing defining the specific mutants expressed in the tumor and able to be recognized by the immune system.
Measured: at Day 0
Prognostic value of the tumor non invasive biomarkers
The analysis of circulating DNA (ctDNA) will be performed from plasma collected from the prospective cohort of the patients for the three types of cancer (NHL, lung cancer and glioma). DNA will be extracted and amplified followed by Next-Generation Sequencing (NGS) and Droplet digital PCR (ddPCR) analysis for the identification of new biomarkers and/or for the follow up of mutations previously identified on tumor DNA. Results will be compared to tissue results in each group and to CTCs results in the Lung cancer group and prognostic values of these biomarkers will be assessed from clinical datas.
Measured: at Day 0, Month 3 and Month 6
Prognostic value of the tumor non-invasive biomarkers
The analysis of circulating tumor cells (CTCs) will be performed from whole peripheral blood collected from the prospective cohort of patients with lung cancer infected or not with HIV. CTC fraction will be prepared from a cell size-based enrichment protocol. Then, DNA and RNA will be extracted and amplified followed by Next-Generation Sequencing (NGS) and RNA sequencing for the identification of new biomarkers. Droplet digital PCR (ddPCR) analysis will also be performed for validation and patient follow-up. Mutations and expression data in CTC will be compared to tissue and ctDNA in the two groups and prognostic values of these biomarkers will be assessed from clinical datas.
Measured: at Day 0, Month 3 and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start20 Nov 2018
- Primary completion6 Jul 2023
- Study completion6 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe SPANO, MD, PhD, Study chair, Pitié-Salpêtrière hospital (APHP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706625
- Sponsor's protocol ID
- NI18022J
- Other IDs
- 2018-A01099-46
- Acronym
- IDeATIon
- Status last verified
- Nov 2023
- First submitted
- 10 Aug 2018
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Abbar B, Labreche K, Cadranel J, Veyri M, Morin V, Thiam FS, Desire N, Baron M, Guillerm E, Perrier A, Fallet V, Maitre T, Canellas A, Tarantino N, Mze O, Samri A, Dejancourt L, Nakid-Cordero C, Vozy A, Picca A, Touat M, Guihot A, Chouaid C, Mokhtari K, Bielle F, Brocheriou I, Rouvier P, Osorio AR, Buob D, Bouzidi A, Marie Y, Assouad J, Boelle PY, Coulet F, Vieillard V, Spano JP, Autran B. Human Immunodeficiency Virus Impairs Immune Responses to Tumor Neoepitopes Without Altering Mutational Profiles in NSCLC. J Thorac Oncol. 2025 Jul;20(7):897-911. doi: 10.1016/j.jtho.2025.02.001. Epub 2025 Feb 7.
PubMed 39923848
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Discovery of New Immuno-Molecular Actionable Biomarkers for Tumors With Immune-suppressed Environment
- ClinicalTrials.gov ID
- NCT03706625
- Acronym / sponsor ID
- IDeATIon / NI18022J
- Conditions
- Non Hodgkin Lymphoma, Non Small Cell Lung Cancer, Glioma
- Keywords
- Non Hodgkin Lymphoma, glioma, lung cancer, HIV, transplantation, brain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 6 Jul 2023 (actual)
- Study completion
- 6 Jul 2023 (actual)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The explosion of novel therapies targeting tumor mutations or immune molecules requests to define or better characterize the mutational profiles of tumors that are none or insufficiently explored so far. This is particularly the case for tumors arising in immune-suppressed individuals or environments which have been poorly, if any, analyzed so far with modern molecular methods. The goal of the translational research program, Ideation, is to define novel biomarkers such as the tumor mutational profiling and immunomutanome in such contexts and to compare the results obtained to those observed in immune competent individuals. In addition, this approach will allow to characterize novel key non-invasive diagnostic and prognostic biomarkers such as circulating tumoral DNA and cells. Altogether results will provide novel biomarkers to better adapt therapeutic strategies in these cancers, to monitor response to treatment as well as to define new molecular targets of potential therapeutic strategies.
Detailed description
The main objective is to discover novel invasive and non-invasive immuno-molecular actionable biomarkers in rare but severe tumors arising in immune-suppressed compared for some tumors in immune-competent patients. Indeed, this tumors present a deficient immune environment, either due to the host acquired immune deficiency, i.e. transplantations or HIV infection, or because the diseased tissue belongs in an immune sanctuary as the brain. The primary hypothesis, in this context, is that these tumor mutational profiles and their changes during drug therapy must be influenced by the immune environment and response. This must lead to differences from similar tumors observed in immune-competent environments (immunocompetent individuals or tissues expressing immunity), responsible for: modification in the molecular targets for appropriate drugs ; alteration of tumor immunogenicity and of future immune-based therapies ; specific biomarkers for monitoring the response to drug therapy. The objectives of this program are to carry on invasive and non-invasive investigations in order to define the mutational profile of these free types of severe tumors, non-Hodgkin lymphoma (NHL), lung cancers and gliomas arising in hosts or tissues with altered immunity. These investigations will lead to : identify novel invasive and non-invasive biomarkers for predicting and evaluating efficacy of future personalized and immune-based therapies; compare tumors from immune-suppressed and immune-competent hosts; discover hot spots of tumoral mutations as mechanisms of tumors resistance, new molecular targets for future molecular and immune-bases therapeutic strategies; define the tumor immunomutanome as a score of neo-epitopes predicting: tumor immunogenicity, disease outcome and efficacy of immunotherapies; detect non-invasive tumoral biomarkers from liquid biopsies based on Circulating tumoral DNA and Circulating tumoral Cells to facilitate future diagnosis and monitoring of such tumors; identify biomarkers of tumor escape or resistance to treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Non-Hodgkin-Lymphoma (after transplantation) | – | –Immune-suppressed patients suffering from Non-Hodgkin-Lymphoma (after transplantation) and followed in the four centers of reference for rare cancers (KVirogref, CANCERVIH, LOC and POLA) |
| Non-small cell lung cancer | – | –Immune-suppressed patients suffering from HIV-related non-small cell lung cancer, followed in the four centers of reference for rare cancers (KVirogref, CANCERVIH, LOC and POLA) |
| Primary Central Nervous System Lymphoma | – | –Patients suffering from primitive cerebral lymphomas and followed in the four centers of reference for rare cancers (KVirogref, CANCERVIH, LOC and POLA) |
| Gliomas | – | –Patients suffering from Gliomas and followed in the four centers of reference for rare cancers (KVirogref, CANCERVIH, LOC and POLA) |
| Non-Hodgkin-Lymphoma with HIV infection | – | –Immune-suppressed patients (during HIV infection) and followed in the four centers of reference for rare cancers (KVirogref, CANCERVIH, LOC and POLA) |
| Immunocompetent Non-Hodgkin-Lymphoma | – | –Immunocompetent patients and followed in the four centers of reference for rare cancers (KVirogref, CANCERVIH, LOC and POLA). |
| Immunocompetent Non-small cell lung cancer | – | –Immunocompetent patients suffering from non-small cell lung cancer and followed in the four centers of reference for rare cancers (KVirogref, CANCERVIH, LOC and POLA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed-up at Pitié-Salpêtrière hospital, Tenon hospital, Henri Mondor hospital, Saint-Louis hospital or intercommunal hospital center of Créteil with histological diagnosis of HIV-related non-small cell lung cancer, immunocompetent non-small cell lung cancer, HIV-related Non-Hodgkin-Lymphomas (NHL), immunocompetent NHL, post-transplant NHL, primary lymphoma of the central nervous system, glioma.
Key inclusion criteria (15 listed)
- Age ≥ 18 years.
- Followed at Pitié-Salpêtrière hospital, Tenon hospital, Henri Mondor hospital, Saint-Louis hospital or intercommunal hospital center of Créteil
- Histological diagnosis confirmed of:
- Naïve cancer treatment (except for the specific case of gliomas with certain or possible activation of MAPK (Mitogen-activated protein kinases) and MMR (Mismatch Repair) inactivation).
- Cancer undergoing surgery for excision or a large biopsy (pleural biopsy under video-thoracoscopy, mediastinoscopy, biopsy lymph node excision or cutaneous or cerebral metastasis).
Key exclusion criteria (8 listed)
- Other cancer than those in the study:
- Absence of tumor material, blood or saliva samples taken before the start of chemotherapy (except for the specific case of gliomas with certain or possible activation of MAPK and MMR inactivation)
- Major under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prognostic value of the tumor invasive biomarkers
Time frame: at Day 0
Analyze of the tumor biomarkers on frozen biopsy for the three types of cancer (NHL, lung cancer and glioma)
3 secondary outcomes
Determination of tumoral biomarkers
Time frame: at Day 0
Prognostic value of the tumor non invasive biomarkers
Time frame: at Day 0, Month 3 and Month 6
Prognostic value of the tumor non-invasive biomarkers
Time frame: at Day 0, Month 3 and Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Derived from this study: PubMed 39923848Abbar B, Labreche K, Cadranel J, Veyri M, Morin V, Thiam FS, Desire N, Baron M, Guillerm E, Perrier A, Fallet V, Maitre T, Canellas A, Tarantino N, Mze O, Samri A, Dejancourt L, Nakid-Cordero C, Vozy A, Picca A, Touat M, Guihot A, Chouaid C, Mokhtari K, Bielle F, Brocheriou I, Rouvier P, Osorio AR, Buob D, Bouzidi A, Marie Y, Assouad J, Boelle PY, Coulet F, Vieillard V, Spano JP, Autran B. Human Immunodeficiency Virus Impairs Immune Responses to Tumor Neoepitopes Without Altering Mutational Profiles in NSCLC. J Thorac Oncol. 2025 Jul;20(7):897-911. doi: 10.1016/j.jtho.2025.02.001. Epub 2025 Feb 7.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Philippe SPANO, MD, PhD study chair
Pitié-Salpêtrière hospital (APHP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Hodgkin Lymphoma and Non Small Cell Lung Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic value of the tumor invasive biomarkers (time frame: at Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03706625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.