Deciphering Mechanisms Underlying Cancer Immunogenicity (DECIDE)

July 21, 2023 updated by: Institut Claudius Regaud

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Toulouse, France, 31059
      • Toulouse, France
      • Toulouse, France, 31059

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional 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
Patient receiving an anticancer treatment in the context of their standard care.
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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2020

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

May 20, 2019

First Submitted That Met QC Criteria

May 20, 2019

First Posted (Actual)

May 21, 2019

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19 GENE 13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cervical Cancer

Clinical Trials on Blood samples, tumor biopsy specimens and ascites samples will be collected.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe