Clinical trial NCT05223608: Prospective Cohort With Clinic-biologic Database of Patients Treated by Immunotherapy
Official title: Prospective Cohort With Clinic-biologic Database of Patients Treated by Immunotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Solid Tumor, Adult
Keywords: Prospective cohort
Clinic-biologic database
Solid tumor
Immunotherapy
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2022-02-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Observational study model with additional blood samples and urine collection
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

* Describe overall survival, progression-free survival, response to immunotherapy (in particular hyper-progression, pseudo-progression) considering the first tumor assessment and the best response, prolonged response
* Identifying prognostic factors of overall survival, progression-free survival, hyper-progression, best response under immunotherapy
* Describe AEs (Adverse Events) potentially associated with immunotherapy, their kinetics of appearance, from the start of treatment and after the end of treatment in order to assess the risk of delayed appearance
* To identify factors associated with increased risk of severe adverse event (grade \> 2 or leading to end of treatment) potentially related to immunotherapy, from the beginning of immunotherapy to 1 year after this start of the treatment, in patients who received at least 4 doses or who stopped the treatment earlier (before 4 doses) due to toxicity.
* Identifying delayed adverse events potentially related to immunotherapy, occurring between 90 days and 1 year after the treatment discontinuation, in patients who received at least 4 doses or who stopped the treatment earlier (before 4 doses) due to toxicity.
* To identify and describe rare toxicities
* To evaluate the association between co-medications and disease evolution
* To evaluate the association between co-medications and toxicities occurrence

Translational research objectives:

* To identify biomarkers that might be associated with tumor response and/or toxicity of immunotherapy from:

  * Establishment of serum and plasma bank which will be used for diverse works;
  * A systematic analysis of the lymphocyte profile
* To study the impact of tabagism on efficacy and toxicity of immunotherapy from systematic collection of urinary cotinine.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Beginning a first immunotherapy by immune checkpoint inhibitor - anti-PD1 (Programmed cell Death protein-1), anti-PDL1 (Programmed cell Death protein-1 ligand), anti-CTLA4 (Cytotoxic T-Lymphocyte associated protein 4), as monotherapy or in combination, in the Centre Oscar Lambret (COL)
* In neo-adjuvant, adjuvant, recurrence or metastatic situation
* Suffering from solid tumor histologically documented
* Signed written informed consent
* Patient covered by the French " "Social Security" regime If the patient is already enrolled in clinical trial involving immunotherapy, the agreement of the sponsor of this new trial will be sought before his/her inclusion.

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patient already treated by immunotherapy by immune checkpoint inhibitor
* Person under guardianship
* Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons)

Primary outcomes:
measure: Number of patients treated by immunotherapy and registered in the database.
timeFrame: 5 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 6 years
measure: Progression-Free Survival
timeFrame: 6 years
measure: Tumor response
timeFrame: 6 years
measure: Co-medications
timeFrame: 6 years
measure: Toxicity of immunotherapy
timeFrame: 6 years
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
state: Hauts-de-France
Study officials:
affiliation: Centre Oscar Lambret
name: Alexandra FORESTIER, MD
role: PRINCIPAL_INVESTIGATOR
References: