Centre Oscar Lambret
Lille, Hauts-de-France, 59, France
Location status: Recruiting
Location contact
Alexandra FORESTIER
CONTACT
Alexandra FORESTIER
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05223608
ImmuCCo-1905 is a monocentric interventional study on patients treated by immunotherapy, which consist in establishment of a prospective clinic-biologic database over 5 years, associated with a biobank. This database will allow carrying out works aiming at assessing immunotherapy in real life situation.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Lille, Hauts-de-France, 59, France
Location status: Recruiting
Alexandra FORESTIER
CONTACT
Alexandra FORESTIER
PRINCIPAL_INVESTIGATOR
The aim of this study is to establish a prospective clinic-biologic database of patients treated by immunotherapy. This database will allowed to carry out works (such as translational research) aiming at assessing immunotherapy in real life situation.
Other objectives of the study include:
Translational research objectives:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Blood sampling at initiation of immunotherapy, at the first tumor assessment, in case of severe toxicity. Urine collection at initiation of immunotherapy.
Time frame: 5 years
Number of patients treated by immunotherapy and registered in the database
Time frame: 6 years
Time between date of start of immunotherapy to date of death whatever the cause. Patients alive at last follow-up will be censored.
Time frame: 6 years
Time between start of immunotherapy to date of disease progression or death whatever the cause. Alive, non-progressive patients at last follow-up will be censored.
Time frame: 6 years
Tumor response will be based on the first tumor assessment performed during the immunotherapy. Objective response according to iRECIST (Response Evaluation Criteria in Solid Tumours for immunotherapy) criteria will be defined at the first tumor assessment and during the course of the treatment, meaning until disease progression of start of another systemic treatment.
Responses will be: Complete response (iCR), partial response (iPR), stability (iSD), progression, or pseudo-progression. Confirmed progressive disease (iCPD) will be distinguished from pseudo-progression (iUPD) according to control images. Hyper-progression will be defined as a progression according to iRECIST criteria and a doubling of tumor growth rate.
A prolonged tumor response will be defined as a progression free survival duration at least 3 time superior to median duration of progression free survival of patients of the study presenting the same disease.
Time frame: 6 years
All comedications given during the course of the study will be compiled
Time frame: 6 years
All Adverse events occuring from the start of the immunotherapy to the follow-up performed on year after the end of the immunotherapy will be notified, whatever the grade and the relationship with immunotherapy, apart from those undoubtfully related to the disease or the progression of the disease.The AE will also be notified in case of start of a second line of treatment, apart from thos undoubtfully related to this second line of treatment. The main analysis will be done on AE potentially related to immunotherapy. The relationship will be evaluated by a medical expert of immunotherapy. AE will be graded according to CTCAE v5.0 classification. Patients who received less than 4 doses will be considered non-evaluable for this outcome apart from those who discontinued treatment because they had a toxicity. Each AE with a grade > 2 and/or leading to treatment discontinuation will be considered as severe.
Contact information is provided by the study sponsor or research team.
Julien THERY
CONTACT
Marjane BELMIMOUN
CONTACT
Centre Oscar Lambret
Other
Acronym: ImmuCCo
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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