Creating a database for patients treated with immunotherapy for solid tumors
Prospective Cohort With Clinic-biologic Database of Patients Treated by Immunotherapy
This study is creating a database to track how well immunotherapy works and its side effects in patients with solid tumors over five years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 651 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Oscar Lambret Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Lille, Hauts-de-France) |
| Trial ID | NCT05223608 on ClinicalTrials.gov |
What this trial studies
This study aims to establish a prospective clinic-biologic database over five years for patients undergoing immunotherapy for solid tumors. It will collect data on overall survival, progression-free survival, and responses to treatment, including adverse events associated with immunotherapy. The database will facilitate translational research to assess the effectiveness and safety of immunotherapy in real-world settings. Additionally, it will identify prognostic factors and delayed adverse events related to treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are beginning their first immunotherapy treatment with immune checkpoint inhibitors for solid tumors.
Not a fit: Patients who have previously received immunotherapy or are currently pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of immunotherapy's effectiveness and safety, leading to improved treatment strategies for patients with solid tumors.
How similar studies have performed: Other studies have shown success in using similar approaches to assess immunotherapy, but this specific database initiative is novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Lille, Hauts-de-France
- Centre Oscar Lambret — Lille, Hauts-de-France, France (Recruiting)
Study contacts
- Principal investigator: Alexandra FORESTIER, MD — Centre Oscar Lambret
- Study coordinator: Julien THERY
- Email: promotion@o-lambret.fr
- Phone: +330320295918
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.