Status:
RECRUITING
Exploration of Adaptive Antitumoral Immune Cells Through Lymphapheresis in Cancer Patients : ALCYTA
Lead Sponsor:
Institut Curie
Conditions:
Cancer
Immune System or Toxicities Suspected
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study will evaluate the detection of tumor-antigen specific immune cells in cancer patients in whom the role of the immune system is suspected.
Eligibility Criteria
Inclusion
- Patient aged 18 or over,
- Patient presenting an invasive tumor pathology (proven or suspected). The location and / or stage of which are defined for each cohort through an amendment to the protocol,
- Patient treated with immune-modulators or other treatments likely to modify immunological parameters,
- Suspicion of immune mediated response or toxicities (assessed by the immunologists),
- Peripheral venous capital usable and compatible with the realization of 2 venous accesses for lymphapheresis and absence of cardiovascular problem (heart failure, arrhythmia ...), per investigator assessement,
- Total circulating lymphocytes\> 1000 / mm3,
- Availability of DNA and RNA from the tumor,
- Information to the patient and signature of informed consent or his legal representative,
- Affiliated with a social security scheme or such a scheme.
Exclusion
- Inability to undergo study follow-up for geographical, social or psychological reasons,
- Infection with HIV or hepatitis B or C viruses,
- Patients on high dose corticosteroid treatment (\> 1 mg / kg continuously),
- Any concomitant serious illness that may interfere with participation in the study or significantly affect the results of the study (pulmonary, heart or liver disease),
- Contraindication to performing lymphapheresis (coagulation disorder, cardiovascular problems, venous access, hypocalcemia, psychological inability to undergo extracorporeal circulation, cachexia, etc.),
- Pregnant patient or of childbearing age without effective contraception,
- Persons deprived of their liberty, under guardianship or legal protection.
Key Trial Info
Start Date :
August 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 3 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05354765
Start Date
August 31 2022
End Date
September 3 2026
Last Update
January 24 2025
Active Locations (2)
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1
Institut Curie
Paris, France, 75005
2
Institut Curie
Saint-Cloud, France, 92210