Deciphering Mechanisms Underlying Cancer Immunogenicity

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03958240
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Institut Claudius Regaud
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Head and Neck Cancer, Ovarian Cancer, Cervical Cancer, Cervical Intraepithelial Neoplasia 3, Glioblastoma Multiforme of Brain Stem, Non Small Cell Lung Cancer, Anal Cancer

Arms & Interventions

Arms

Other: Patient with local and/or metastatic solid malignant tumor

Patient receiving an anticancer treatment in the context of their standard care.

Interventions

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): 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).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hopital Larrey, Toulouse, France

Status

Recruiting

Address

Hopital Larrey

Toulouse, , 31059

Site Contact

Julien MAZIERES

[email protected]

05 67 77 18 37

Hopital Rangueil, Toulouse, France

Status

Recruiting

Address

Hopital Rangueil

Toulouse, , 31059

Site Contact

Rosine GUIMBAUD

[email protected]

05 61 32 21 42

Toulouse, France

Status

Recruiting

Address

Institut Universitaire du Cancer Toulouse - Oncopole

Toulouse, ,

Site Contact

Alejandra MARTINEZ

[email protected]

+33 5 31 15 53 66

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