Informations générales (source: ClinicalTrials.gov)
A Multicenter Observational Cohort for HIV Infected Patients With a Cancer Treated by Immune-Checkpoint Inhibitors. (OncoVIHAC)
Observational [Patient Registry]
ANRS, Emerging Infectious Diseases (Voir sur ClinicalTrials)
janvier 2018
juin 2022
28 décembre 2024
A Multicenter, Observational, National Cohort for HIV Infected Patients with a Cancer
treated by Immune-Checkpoint Inhibitors (ICPi) for less than one month or to be treated
with an ICPi such as anti-PD-1 or anti-PDL-1 or anti-CTLA4, monitored in some French
hospitals .
The objective of the study is to assess the safety of these new agents in HIV-infected
patients.
As an observatory, the number of participants planned is not predetermined: the aim is to
include for 2 years any participant infected with HIV and having a cancer treated by ICPi
in one of the centers that have agreed to participate.
50 participants will be recruited for Substudy "OncoVIRIM" during the study period
(regardless of tumor type or ICPi type); 8 or 9 time points (blood samples) will be
scheduled
The cohort " ANRS CO24 OncoVIHAC " is declared to authorities like category 2 research .
No intervention in the observatory, a collection of data will be carried out in M0, M6,
M12, M18 and M24.
For the physiopathological Substudy OncoVIRIM : Blood samples will be collected to
constitute cell bank, plasma bank, serum bank, DNA bank in order to meet the objectives
of this substudy and possibly for complementary research
Etablissements
Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
---|---|---|---|---|---|
CHI DE CRETEIL | Valérie GARRAIT | 29/03/2024 01:28:34 | Contacter | ||
CLCC INSTITUT GUSTAVE ROUSSY | Aur�lien MARABELLE | 21/02/2024 10:21:07 | Contacter | ||
HOPITAL FOCH | LOUIS-JEAN COUDERC | 23/12/2024 08:04:15 | Contacter | ||
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
AP-HP - Hôpital Bichat | Yazdan YAZDANPANAH, MD | Contact (sur clinicalTrials) | |||
AP-HP - Hôpital Europeen Georges Pompidou | Laurence WEISS, MD | Contact (sur clinicalTrials) | |||
AP-HP - Hôpital Henri Mondor-Albert Chenevier | Corinne HAIOUN, MD | Contact (sur clinicalTrials) | |||
AP-HP - Hôpital Saint Antoine | Karine LACOMBE, MD | Contact (sur clinicalTrials) | |||
AP-HP - Hôpital Tenon | Armelle LAVOLE, MD | Contact (sur clinicalTrials) | |||
CH DE VERSAILLES SITE ANDRE MIGNOT | Alix GREDER-BELAN, MD | Contact (sur clinicalTrials) | |||
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
Ambulatoire-Hôpital de Jour - Institut Paoli Calmettes - 13273 - Marseille - France | Jean-François MOULIN, MD | Contact (sur clinicalTrials) | |||
Centre Hospitalier Universitaire de Saint Etienne - 42270 - Saint-Priest-en-Jarez - France | Anne FRESARD, MD | Contact (sur clinicalTrials) | |||
Chirurgie Urologique et Tranplantation Rénale - Hôpital de la Conception - 13385 - Marseille - France | Eric LECHEVALLIER, MD | Contact (sur clinicalTrials) | |||
Institut de Cancérologie Lucien Neuwirth - 42270 - Saint-Priest-en-Jarez - France | Pierre FOURNEL, MD | Contact (sur clinicalTrials) | |||
Le Trait d'Union - Hôpitaux Universitaires de Strasbourg - 67091 - Strasbourg - France | Marie-Laure BATARD, MD | Contact (sur clinicalTrials) | |||
Pôle de Médecine 2 - Centre Hospitalier Andrée Rosemon - 97306 - Cayenne - France | Contact (sur clinicalTrials) | ||||
Service de Dermatologie - Hôpital l'Archet - 06202 - Nice - France | Alexandra PICARD, MD | Contact (sur clinicalTrials) | |||
Service de dermatologie - Hôpital St Joseph - 13285 - Marseille - France | Frank TOLLINCHI, MD | Contact (sur clinicalTrials) | |||
Service de Médecine Interne - Centre Hospitalier de Martigues - 13695 - Martigues - France | Rolande COHEN VALENSI, MD | Contact (sur clinicalTrials) | |||
Service de Médecine interne - Hôpital Antoine Béclère - 92141 - Clamart - France | Jean-François BOUE, MD | Contact (sur clinicalTrials) | |||
Service de Médecine Interne - Hôpital d'Instruction des Armées Saint Anne - 83041 - Toulon - France | Jean-Pierre DE JAUREGUIBERRY, MD | Contact (sur clinicalTrials) | |||
Service de médecine interne Cancérologie - Hôpital l'Archet - 06202 - Nice - France | Eric ROSENTHAL, MD | Contact (sur clinicalTrials) | |||
Service de Médecine interne-Immunologie clinique - Hôpital Bicêtre - 94276 - Le Kremlin-Bicêtre - France | Olivier LAMBOTTE, MD | Contact (sur clinicalTrials) | |||
Service de Pneumologie - Hôpital St Joseph - 13285 - Marseille - France | Christina AUDOLY, MD | Contact (sur clinicalTrials) | |||
Service de pneumologie - Hôpital Victor Dupouy - 95100 - Argenteuil - France | Laure BELMONT, MD | Contact (sur clinicalTrials) | |||
Service de pneumologie - Hôpital Yves Le Foll - 22000 - Saint-Brieuc - France | Gwenaëlle LE GARFF, MD | Contact (sur clinicalTrials) | |||
Service dermatologie/vénéréologie - Hôpital de la Timone - 13385 - Marseille - France | Jean-Jacques GROB, MD | Contact (sur clinicalTrials) | |||
Service des Maladies Infectieuses - Hôpital Saint-Louis - 75475 - Paris - France | Diane PONSCARME, MD | Contact (sur clinicalTrials) | |||
Service des Maladies Infectieuses et du Voyageur - Centre Hospitalier de Tourcoing - 59208 - Tourcoing - France | Faïza AJANA, MD | Contact (sur clinicalTrials) | |||
Service des Maladies Infectieuses et Tropicales - Hôpital de la Croix Rousse - 69317 - Lyon - France | Laurent COTTE, MD | Contact (sur clinicalTrials) | |||
Service des Maladies Infectieuses et Tropicales - Hôpital Gabriel Montpied - 63000 - Clermont-Ferrand - France | Christine JACOMET, MD | Contact (sur clinicalTrials) | |||
Service des Maladies Infectieuses et Tropicales - Hôpital Gui de Chauliac - 34295 - Montpellier - France | Alain MAKINSON, MD | Contact (sur clinicalTrials) | |||
Service des Maladies Infectieuses et Tropicales - Hôpital Jean Minjoz - 25030 - Besançon - France | Catherine CHIROUZE, MD | Contact (sur clinicalTrials) | |||
Service des Maladies Infectieuses et Tropicales - Hôpital l'Archet - 06202 - Nice - France | Alissa NAQVI, MD | Contact (sur clinicalTrials) | |||
Service des Maladies Infectieuses et Tropicales - Hôpital Pitié-Salpêtrière - 75651 - Paris - France | Christine KATLAMA, MD | Contact (sur clinicalTrials) | |||
Service des Maladies Infectieuses et Tropicales - Hôpital Purpan - 31059 - Toulouse - France | Pierre DELOBEL, MD | Contact (sur clinicalTrials) | |||
Service d'hématologie - Hôpital Gabriel Montpied - 63000 - Clermont-Ferrand - France | Cécile MOLUCON-CHABROT, MD | Contact (sur clinicalTrials) | |||
Service d'Hématologie Oncologie - Centre Hospitalier du Pays d'Aix - 13616 - Aix-en-Provence - France | Thierry ALLEGRE, MD | Contact (sur clinicalTrials) | |||
Service d'hématologie-Cisih - Hôpital Sainte Marguerite - 13274 - Marseille - France | Isabelle POIZOT-MARTIN, MD | Contact (sur clinicalTrials) | |||
Service d'Immunologie - Hôpital Felix Guyon - 97405 - La Réunion - Saint-Denis - France | Catherine GAUD, MD | Contact (sur clinicalTrials) | |||
Service d'immuno-pathologie clinique - Hôpital Saint-Louis - 75475 - Paris - France | Laurence GERARD, MD | Contact (sur clinicalTrials) | |||
Service d'Onco-Hématologie Immunodépression - Hôpital Henri Duffaut - 84000 - Avignon - France | Gilles PICHANCOURT, MD | Contact (sur clinicalTrials) | |||
Service d'Oncologie médicale - Hôpital de la Timone - 13385 - Marseille - France | Jean-Laurent DEVILLE, MD | Contact (sur clinicalTrials) | |||
Service d'Oncologie Médicale - Hôpital Pitié-Salpêtrière - 75651 - Paris - France | Jean-Philippe SPANO, MD | Contact (sur clinicalTrials) | |||
Service d'oncologie multidiscliplinaire - Hôpital Nord - 13915 - Marseille - France | Laurent GREILLIER, MD | Contact (sur clinicalTrials) | |||
Service Hématologie Clinique - Hôpital Pitié-Salpêtrière - 75651 - Paris - France | Sylvain CHOQUET | Contact (sur clinicalTrials) | |||
Service Infectiologie - Hôpital de l'Hôtel-Dieu - 75101 - Paris - France | Dominique SALMON-CERON, MD | Contact (sur clinicalTrials) | |||
Service Médecine interne - Maladies Infectieuses - Hôpital Yves Le Foll - 22000 - Saint-Brieuc - France | Corinne DANIEL, MD | Contact (sur clinicalTrials) | |||
Service Oncologie Hématologie - Hôpital Yves Le Foll - 22000 - Saint-Brieuc - France | Corinne ALLEAUME, MD | Contact (sur clinicalTrials) | |||
Servide de Dermatologie - Hôpital Saint-Louis - 75475 - Paris - France | Céleste LEBBE, MD | Contact (sur clinicalTrials) |
Critères
Tous
Study Population for Cohort
Inclusion criteria :
- Age ≥ 18 years
- Documented HIV-1 infection treated or untreated with antiretrovirals
- Cancer histologically and /or cytologically proven
- Person treated for less than 30 days or who should be treated with anti-PD-1 or
anti-PDL-1 or anti-CTLA4 according to current recommendations
- Signed informed consent
Exclusion Criteria
- Subject participating in clinical trials "CHIVA 2" (Lung Cancer- IFCT) and "HANOVRE"
(Hodgkin's disease - LYSA)
Study Population for the Physiopathological Substudy "OncoVIRIM":
Inclusion criteria:
- Participant included in the observatory
- Stable antiretroviral therapy (ART) with controlled HIV-RNA plasma viral load ≤ 50
copies/mL
- Beneficiary of a Social Security program (State Medical Aid or AME is not a Social
Security program), article L1121-11 of the Public health code...
- Signed informed consent.
Non Inclusion Criteria
- Brain or lung radiotherapy < 30 days
- Transplant organ or bone marrow transplant
- Corticosteroid > 10 mg per day
- Participant who started ICPi treatment prior to inclusion in the observatory
Inclusion criteria :
- Age ≥ 18 years
- Documented HIV-1 infection treated or untreated with antiretrovirals
- Cancer histologically and /or cytologically proven
- Person treated for less than 30 days or who should be treated with anti-PD-1 or
anti-PDL-1 or anti-CTLA4 according to current recommendations
- Signed informed consent
Exclusion Criteria
- Subject participating in clinical trials "CHIVA 2" (Lung Cancer- IFCT) and "HANOVRE"
(Hodgkin's disease - LYSA)
Study Population for the Physiopathological Substudy "OncoVIRIM":
Inclusion criteria:
- Participant included in the observatory
- Stable antiretroviral therapy (ART) with controlled HIV-RNA plasma viral load ≤ 50
copies/mL
- Beneficiary of a Social Security program (State Medical Aid or AME is not a Social
Security program), article L1121-11 of the Public health code...
- Signed informed consent.
Non Inclusion Criteria
- Brain or lung radiotherapy < 30 days
- Transplant organ or bone marrow transplant
- Corticosteroid > 10 mg per day
- Participant who started ICPi treatment prior to inclusion in the observatory