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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05813418
Other study ID # PI2019_843_0078
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 2, 2021
Est. completion date July 2024

Study information

Verified date April 2023
Source Centre Hospitalier Universitaire, Amiens
Contact Gwladys BOURDENET, DR
Phone 03.22.08.70.72
Email bourdenet.gwladys@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In the last decades, cancer treatment was based on surgery, radiotherapy and chemotherapy. Recently, treatments have largely evolved, first with targeted therapies (notably tyrosin kinase inhibitors, TKI) and then with immune checkpoint inhibitors (ICPI, notably anti-CTLA-4 and anti- PD1). The last ones can induce durable anti-tumoral responses in patients, even if metastases are present. Their mechanisms of action are focused on the activation of immune system in order to eliminate the tumor. ICPI, because of their mechanisms of action, target immune tolerance key components and can induce important immune toxicities (colitis, hepatitis, dermatitis, thyroiditis ...), leading to early discontinuation of treatment, severe or chronic morbidity, and can sometimes be lethal. It is of importance to detect patient at risk of irAEs, because of the increasing use of ICPI and the long- term response capacity in treated patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date July 2024
Est. primary completion date July 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patient with cancer, whatever initial tumoral histology and disease stage under ICPI treatment (anti-PD1 and/or anti-CTLA-4) - age > 18 - followed in oncology, pneumology, dermatology, gastroenterology departments of Amiens-Picardie University Hospital or Saint Quentin hospital - who received verbal and written information, and signed the consent form for the study Exclusion Criteria: - non ICPI treated patients - patient who received a first line of ICPI treatment - patient who received or is receiving MEK inhibitors as a treatment (because of possible lower response to ICPI treatment when associated)

Study Design


Intervention

Biological:
blood retriewal
blood retriewal for cytokine concentration measurement

Locations

Country Name City State
France CHU Amiens Picardie Amiens Picardie

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens Central Hospital Saint Quentin

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Variation from baseline of IL6 concentration in riAEs patients Variation from baseline of IL6 concentration (pG/mL) in riAEs patients 6 months
Primary Variation from baseline of IL10 concentration in riAEs patients Variation from baseline of IL10 concentration (pG/mL) in riAEs patients 6 months
Primary Variation from baseline of IL15 concentration in riAEs patients Variation from baseline of IL15 concentration (pG/mL) in riAEs patients 6 months
Primary Variation from baseline of IL8 concentration in riAEs patients Variation from baseline of IL8 concentration (pG/mL) in riAEs patients 6 months
Primary Variation from baseline of INFgamma concentration in riAEs patients Variation from baseline of INFgamma concentration (pG/mL) in riAEs patients 6 months
Primary Variation from baseline of MCP-1 concentration in riAEs patients Variation from baseline of MCP-1 concentration (pG/mL) in riAEs patients 6 months
Primary Variation from baseline of MIP 1 alpha concentration in riAEs patients Variation from baseline of MIP 1 alpha concentration (pG/mL) in riAEs patients 6 months
Primary Variation from baseline of MIP 1 beta concentration in riAEs patients Variation from baseline of MIP 1 beta concentration (pG/mL) in riAEs patients 6 months
Primary Variation from baseline of sIL2R concentration in riAEs patients Variation from baseline of sIL2R concentration (U/mL) in riAEs patients 6 months
Primary Variation from baseline of sIL6R concentration in riAEs patients Variation from baseline of sIL6R concentration (µG/mL) in riAEs patients 6 months
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