Exploring immune cells in cancer patients through blood sampling
Exploration of Adaptive Antitumoral Immune Cells Through Lymphapheresis in Cancer Patients : ALCYTA
This study is testing how immune cells in the blood of cancer patients respond to treatment to help improve future therapies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Curie Academic / other |
| Locations | 2 sites (Paris and 1 other locations) |
| Trial ID | NCT05354765 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the presence of tumor-antigen specific immune cells in patients with invasive tumors, where the immune system's role is suspected. Participants will undergo lymphapheresis to collect blood samples for analysis. The study focuses on patients who are being treated with immune-modulating therapies or have suspected immune-mediated responses. The goal is to better understand the immune response in cancer patients and its implications for treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and over with invasive tumor pathologies and suspected immune system involvement.
Not a fit: Patients who are unable to undergo follow-up due to geographical, social, or psychological reasons may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of immune responses in cancer, potentially leading to more effective treatments.
How similar studies have performed: Other studies exploring immune responses in cancer have shown promise, indicating that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Paris and 1 other locations
- Institut Curie — Paris, France (Recruiting)
- Institut Curie — Saint-Cloud, France (Recruiting)
Study contacts
- Study coordinator: Cyrine EZZILI, PhD
- Email: cyrine.ezzili@curie.fr
- Phone: 0033147111657
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.