Brief Title
Deciphering Mechanisms Underlying Cancer Immunogenicity
Official Title
Deciphering Mechanisms Underlying Cancer Immunogenicity
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.
Study Type
Interventional
Primary Outcome
Percentage of CD4 and CD8 T cells expressing PD-1
Secondary Outcome
Rate of patients presenting a high Trm (Tissue resident memory) infiltrate in tumor samples
Condition
Head and Neck Cancer
Intervention
Blood samples, tumor biopsy specimens and ascites samples will be collected.
Study Arms / Comparison Groups
Patient with local and/or metastatic solid malignant tumor
Description: Patient receiving an anticancer treatment in the context of their standard care.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
900
Start Date
January 17, 2020
Completion Date
September 2029
Primary Completion Date
September 2029
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, +33 5 31 15 53 66, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT03958240
Organization ID
19 GENE 13
Responsible Party
Sponsor
Study Sponsor
Institut Claudius Regaud
Study Sponsor
, ,
Verification Date
July 2022