Deciphering Mechanisms Underlying Cancer Immunogenicity

Study Overview
=================
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.

Official Title
-----------------
Deciphering Mechanisms Underlying Cancer Immunogenicity

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

Intervention / Treatment
-----------------
* Other: Blood samples, tumor biopsy specimens and ascites samples will be collected.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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) Age ≥ 18 years at the time of study entry Patient followed within a standard of care procedure or clinical trial ECOG Performance status 0-2 Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol Patient affiliated to a Social Health Insurance in France Patient may participate to other clinical trials Exclusion Criteria: Known history of positive test for Hepatitis B virus or Hepatitis C virus or Immunodeficiency Virus (HIV) or Hanta virus Any condition contraindicated with blood sampling procedures required by the protocol (including Hemoglobin < 8g/dl) Patient pregnant, or breast-feeding 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 Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient with local and/or metastatic solid malignant tumor<br>Patient receiving an anticancer treatment in the context of their standard care. | Other: Blood samples, tumor biopsy specimens and ascites samples will be collected.<br>* 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): 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, 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of CD4 and CD8 T cells expressing PD-1 |  | 5 years for each patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients presenting a high Trm (Tissue resident memory) infiltrate in tumor samples |  | 5 years for each patient | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Head and Neck Cancer, Ovarian Cancer, Cervical Cancer, Cervical Intraepithelial Neoplasia 3, Glioblastoma Multiforme of Brain Stem, Non Small Cell Lung Cancer, Anal Cancer