NCT03958240

Deciphering Mechanisms Underlying Cancer Immunogenicity

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,100 (estimated)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is a translational, open-label, multicentric, prospective cohort study of 1100 patients aiming to describe the PD-1 (programmed death) expression in T cells (T lymphocytes) in different solid tumors. The study will be conducted on a population of patients with local and/or metastatic malignant solid tumor and who are followed within a standard of care procedure or clinical trial. Patients with any of the following tumor types may be enrolled in the trial: * Head and neck cancer, * Ovarian cancer, * Cervical cancer, * Pre-invasive CIN III cervical cancer (Cervical Intra-epithelial Neoplasia III cervical cancer), * Other solid tumor types (including glioblastoma, NSCLC (Non-small cell lung cancer), anal cancer) Each tumor type will be considered as an independent cohort. For each included patient, biological specimen (tumor sample, blood samples and ascites samples if applicable) will be collected. Study participation of each patient will be 5 years.

Conditions

• Head and Neck Cancer
• Ovarian Cancer
• Cervical Cancer
• Cervical Intraepithelial Neoplasia 3
• Glioblastoma Multiforme of Brain Stem
• Non Small Cell Lung Cancer
• Anal Cancer

Interventions

Type	Name	Description
OTHER	Blood samples, tumor biopsy specimens and ascites samples will be collected.	Blood samples, tumor biopsy specimens and ascites samples will be collected at different time points (if feasible, according to the samples taken in the standard practice) for a maximum follow-up period of 5 years from baseline: * at Baseline. * at every surgical procedure or tumor biopsy. * every 6 months (± 2 months) (only blood sample). * at the time of the progression or recurrence, additional samples will be collected, and optionally at the time of the following progressions or recurrences (if applicable). For patients undergoing a RT treatment, blood samples will be collected before the RT (i.e. at the time of planning CT-scan), at the last session of RT (± 2 days) and 3 months after the end of the RT (± 2 weeks).

Timeline

• Start date: 2020-01-17
• Primary completion: 2033-01-01
• Completion: 2033-01-01
• First posted: 2019-05-21
• Last updated: 2025-09-15

Locations

3 sites across 1 country: France