Clinical trial NCT03958240: Deciphering Mechanisms Underlying Cancer Immunogenicity
Official title: Deciphering Mechanisms Underlying Cancer Immunogenicity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Keywords: Head and Neck Cancer
Ovarian Cancer
Cervical Cancer
Cervical Intraepithelial Neoplasia 3
Glioblastoma Multiforme of Brain Stem
Non Small Cell Lung Cancer
Anal Cancer
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Percentage of CD4 and CD8 T cells expressing PD-1
timeFrame: 5 years for each patient
Secondary outcomes:
measure: Rate of patients presenting a high Trm (Tissue resident memory) infiltrate in tumor samples
timeFrame: 5 years for each patient
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Hopital Larrey
city: Toulouse
country: France
facility: Hopital Rangueil
city: Toulouse
country: France
facility: Institut Universitaire du Cancer Toulouse - Oncopole
Study officials:
References: