Integrated Discovery of New Immuno-Molecular Actionable Biomarkers for Tumors With Immune-suppressed Environment
IDeATIon
2 other identifiers
observational
201
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2018
CompletedFirst Posted
Study publicly available on registry
October 16, 2018
CompletedStudy Start
First participant enrolled
November 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 6, 2023
CompletedNovember 22, 2023
November 1, 2023
4.6 years
August 10, 2018
November 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
at Day 0
Secondary Outcomes (3)
Determination of tumoral biomarkers
at Day 0
Prognostic value of the tumor non invasive biomarkers
at Day 0, Month 3 and Month 6
Prognostic value of the tumor non-invasive biomarkers
at Day 0, Month 3 and Month 6
Study Arms (7)
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).
Eligibility Criteria
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.
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Groupe Hospitalier Pitié-Salpêtrière
Paris, 75013, France
Biospecimen
Blood, saliva, biopsy samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jean-Philippe SPANO, MD, PhD
Pitié-Salpêtrière hospital (APHP)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2018
First Posted
October 16, 2018
Study Start
November 20, 2018
Primary Completion
July 6, 2023
Study Completion
July 6, 2023
Last Updated
November 22, 2023
Record last verified: 2023-11
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.
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.