Cancer, Immune System or Toxicities Suspected
Conditions
Keywords
tumor-antigen specific immune cells, circulating tumor DNA
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.
Interventions
OTHERblood sample
lymphapheresis before and during treatment, blood sample in CellSave® tubes (15mL) will be taken at baseline and three weeks, and EDTA tubes (15mL) will be taken at baseline, 3 weeks after treatment start and at progression
Sponsors
Institut Curie
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient aged 18 or over, 2. 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, 3. Patient treated with immune-modulators or other treatments likely to modify immunological parameters, 4. Suspicion of immune mediated response or toxicities (assessed by the immunologists), 5. 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, 6. Total circulating lymphocytes\> 1000 / mm3, 7. Availability of DNA and RNA from the tumor, 8. Information to the patient and signature of informed consent or his legal representative, 9. Affiliated with a social security scheme or such a scheme.
Exclusion criteria
1. Inability to undergo study follow-up for geographical, social or psychological reasons, 2. Infection with HIV or hepatitis B or C viruses, 3. Patients on high dose corticosteroid treatment (\> 1 mg / kg continuously), 4. 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), 5. Contraindication to performing lymphapheresis (coagulation disorder, cardiovascular problems, venous access, hypocalcemia, psychological inability to undergo extracorporeal circulation, cachexia, etc.), 6. Pregnant patient or of childbearing age without effective contraception, 7. Persons deprived of their liberty, under guardianship or legal protection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the presence of tumor-antigen specific T cells for Cohorts A | before treatment | Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs. |
| Evaluation of the presence of tumor-antigen specific T cells for Cohorts B | between 8 weeks and 18 months after the start of treatment | Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs. |
Countries
France
Contacts
CONTACTCyrine EZZILI, PhD
CONTACTFouzia AZZOUZ
Outcome results
None listed