Deciphering Mechanisms Underlying Cancer Immunogenicity
DECIDE
1 other identifier
interventional
1,100
1 country
3
Brief Summary
This trial is a translational, open-label, multicentric, prospective cohort study of 1100 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable head-and-neck-cancer
Started Jan 2020
Longer than P75 for not_applicable head-and-neck-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2019
CompletedFirst Posted
Study publicly available on registry
May 21, 2019
CompletedStudy Start
First participant enrolled
January 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2033
September 15, 2025
September 1, 2025
13 years
May 20, 2019
September 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of CD4 and CD8 T cells expressing PD-1
5 years for each patient
Secondary Outcomes (1)
Rate of patients presenting a high Trm (Tissue resident memory) infiltrate in tumor samples
5 years for each patient
Study Arms (1)
Patient with local and/or metastatic solid malignant tumor
OTHERPatient receiving an anticancer treatment in the context of their standard care.
Interventions
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) for a maximum follow-up period of 5 years from baseline: * 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, additional samples will be collected, and optionally at the time of the following progressions or recurrences (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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Hopital Larrey
Toulouse, 31059, France
Hopital Rangueil
Toulouse, 31059, France
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2019
First Posted
May 21, 2019
Study Start
January 17, 2020
Primary Completion (Estimated)
January 1, 2033
Study Completion (Estimated)
January 1, 2033
Last Updated
September 15, 2025
Record last verified: 2025-09