Deciphering Mechanisms Underlying Cancer Immunogenicity

Not Applicable

Recruiting

• Conditions: Head and Neck Cancer; Non Small Cell Lung Cancer; Cervical Intraepithelial Neoplasia 3; Ovarian Cancer; Glioblastoma Multiforme of Brain Stem; Anal Cancer; Cervical Cancer
• Interventions: Other: Blood samples, tumor biopsy specimens and ascites samples will be collected.

• Registration Number: NCT03958240
• Lead Sponsor: Institut Claudius Regaud

Brief Summary

This trial is a translational, open-label, multicentric, prospective cohort study of 900 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-20
• Study First Submitted QC: 2019-05-20
• Study First Posted: 2019-05-21
• Study Start: 2020-01-17
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-24
• Primary Completion: 2029-09
• Study Completion: 2029-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

1. Patient with histologically documented local or metastatic solid malignant tumor (head and neck, ovarian, cervical, and other tumor types including, but not limited to glioblastoma, NSCLC and anal cancer) or patients with pre-invasive cervical high grade dysplasia (CIN II or III)
2. Age ≥ 18 years at the time of study entry
3. Patient followed within a standard of care procedure or clinical trial
4. ECOG Performance status 0-2
5. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
6. Patient affiliated to a Social Health Insurance in France
7. Patient may participate to other clinical trials

Exclusion Criteria

1. Known history of positive test for Hepatitis B virus or Hepatitis C virus or Immunodeficiency Virus (HIV) or Hanta virus
2. Any condition contraindicated with blood sampling procedures required by the protocol (including Hemoglobin < 8g/dl)
3. Patient pregnant, or breast-feeding
4. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
5. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with local and/or metastatic solid malignant tumor	Blood samples, tumor biopsy specimens and ascites samples will be collected.	Patient receiving an anticancer treatment in the context of their standard care.

Primary Outcome Measures

Name	Time	Method
Percentage of CD4 and CD8 T cells expressing PD-1	5 years for each patient

Secondary Outcome Measures

Name	Time	Method
Rate of patients presenting a high Trm (Tissue resident memory) infiltrate in tumor samples	5 years for each patient

Trial Locations

Locations (3)

Hopital Larrey; 🇫🇷 Toulouse, France

Hopital Rangueil; 🇫🇷 Toulouse, France

Institut Universitaire du Cancer Toulouse - Oncopole; 🇫🇷 Toulouse, France