In-depth Characterization of Circulating and Infiltrating Immune Subsets and Tumor Cells in Cancer Patients (FUTURE)

February 13, 2025 updated by: Assistance Publique Hopitaux De Marseille

In-depth Characterization of Circulating and Infiltrating Immune Subsets and Tumor Cells in Cancer Patients.

The aim of this study is to describe the tumor microenvironment of solid tumors and to understand the changes induced by anti-cancer treatments, particularly those developed by Innate Pharma. Innate Pharma is a biotechnology company which discovers and develops therapeutic antibodies that exploit the innate immune system to improve cancer treatment. Thanks to this study, it will be possible to correlate clinical and immunological characteristics with the patient's clinical features. The analyses generated will contribute to the design and improvement of innovative therapeutic antibodies acting on the immune system

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Rationale:

The purpose of this study is to characterize the tumor and immune contexture and its circulating counterpart in cancer patients and to understand changes induced by anti-cancer treatments. We will therefore be able to correlate clinical and immunological characteristics with patient clinical status. We expect that the data generated will be used as a decision-support tool for the design and evaluation of new or improved immunotherapy.

Study objectives:

  • Primary objectives:
  • Identification and functional characterization of circulating and infiltrating immune subsets and tumor cells in cancer patients.
  • Discovery and preclinical evaluation of new therapeutic targets in oncology.

Secondary objectives:

  • To evaluate and compare the frequency, phenotype and functionality of leukocytes subsets in the tumor microenvironment, tumor-adjacent tissue and in peripheral blood.
  • To evaluate the expression of proteins targeted by therapeutic antibodies on circulating and tissue-resident cells in cancer patients.
  • To assess the impact of anti-cancer treatments (including but not limited to therapeutic antibodies or chemotherapy) on the tumor and peripheral microenvironment (e.g. frequency and phenotype of leukocyte subsets; expression of targeted proteins or their ligands).
  • To identify correlation between tumor biomarkers / blood biomarkers and biological or clinical characteristics of cancer patients as well as their clinical response to treatment.
  • To characterize ex vivo the modes of action of several anti-cancer treatments.

Study Design:

During this study, patients will not receive any investigational product. Patients are included within their usual schedule of appointments with their surgeon or oncologist. Treatment strategy (surgery, chemotherapy, immunotherapy…) will vary from indication to indication and will not be impacted by participation to this study.

Screening and sampling Period

For patients with solid tumor undergoing surgery (cohort 1), a maximum of 3 visits are planned during this period:

  • A Screening visit for patient evaluation and inclusion/exclusion criteria review
  • Visit 1: For blood sampling specifically for the study;
  • Visit 2: For tumor sampling and blood sampling if not done at Visit 1. Fresh solid tumor lesions and normal adjacent tissue will be macroscopically selected from the resected tumor material by a pathologist. Samples will be collected according to decision of May 3, 2017 establishing a list of researches as mentioned by article L1121-1, paragraph 2° of the French public Health code, and will therefore only concern blood samples, as well tissues collected during surgeries.

The Screening visit and the Visit 1 could occur on the same day.

For patients with solid tumor registered for anti-PD1/PD-L1-based treatment and not undergoing surgery (cohort 2), a maximum of 3 visits are planned during this period:

  • A Screening visit for patient evaluation and inclusion/exclusion criteria review.
  • A Baseline (pre-treatment) visit for blood sampling specifically for the study.
  • A Post-treatment (after immunotherapy administration) for blood sampling specifically for the study.

The Screening and Baseline visits could occur on the same day.

For hematological malignancies (cohort 3), a maximum of 2 visits are planned during this period:

  • A Screening visit;
  • Visit 1: for blood sampling specifically for the study. The Screening visit and the Visit 1 could occur on the same day.

Target patient population:

Age ≥ 18 years with one of the following cancer indication:

  • Lung cancer,
  • Head and neck cancer,
  • Urologic cancer,
  • Liver cancer,
  • Colorectal and gastric cancer,
  • Breast cancer,
  • Lymphoma and leukemia

Study Type

Observational

Enrollment (Estimated)

640

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 Contact Backup

Study Locations

  • France
      • Marseille, France, 13385
        • Hopital Timone enfants - plateforme d'Immunoprofiling
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient from hospitals in Assistance Public Hopitaux de Marseille : Nord, Conception and Timone

Description

Inclusion Criteria:

  • 18 years of age or older
  • Histologic, cytologic or imaging confirmation of a malignancy in accordance with targeted indications
  • Written informed consent signed from subject prior to performing any protocol-related procedures

Exclusion Criteria:

  • Use of any investigational agent within 14 days prior first visit;
  • Patient under guardianship/trusteeship or legally incapacitated person;
  • Patient unable to understand read and/or sign an informed consent;
  • Uncooperative or potentially non-compliant for the study or study procedures patient, or with foreseeable regular follow-up difficulties;
  • Patient without Health insurance scheme or Universal Medical Coverage (CMU) or any equivalent scheme;
  • Patients who are known to be HIV positive

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1 - Patients with solid tumor undergoing surgery

Cohort 1 (patients with solid tumor undergoing surgery):

  • Head and neck cancer: up to 80 patients
  • Urologic cancer: up to 160 patients
  • Liver cancer: up to 80 patients
  • Colorectal and gastric cancer: up to 80 patients
  • Breast cancer: up to 80 patients

A maximum of 3 visits are planned :

  • Screening visit for patient evaluation and inclusion/exclusion criteria review
  • Visit 1: For blood sampling specifically for the study
  • Visit 2: For tumor sampling and blood sampling if not done at Visit 1 Fresh solid tumor lesions and normal adjacent tissue will be macroscopically selected from the resected tumor material by a pathologist. Samples will be collected according to decision of May 3, 2017 establishing a list of researches as mentioned by article L1121-1, paragraph 2° of the French public Health code, and will therefore only concern blood samples, as well tissues collected during surgeries.

The Screening visit and the Visit 1 can occur on the same day.
Procedure: blood collection
Blood sampling is performed during Scrrening / visit 1 for patients enrolled in cohort 1, cohort 2 and cohort 3
Procedure: tissue specimen collection
In Cohort 1- patients with solid tumor undergoing surgery, fresh tissue specimen is collected during surgery
Cohort 2 - Patients with solid tumor with anti-PD1/PD-L1 treatment and no surgery
  • Lung cancer: up to 40 patients
  • Head and neck cancer: up to 40 patients a maximum of 3 visits are planned during this period:
  • A Screening visit for patient evaluation and inclusion/exclusion criteria review.
  • A Baseline visit (pre-treatment) visit for blood sampling specifically for the study
  • A post-treatment visit (after immunotherapy administration) for blood sampling specifically for the study The Screening and Baseline visits can occur on the same day.
Procedure: blood collection
Blood sampling is performed during Scrrening / visit 1 for patients enrolled in cohort 1, cohort 2 and cohort 3
Cohort 3 - Patients with hematological malignancies

- Lymphoma and leukemia: up to 80 patients

A maximum of 2 visits are planned during this period:

  • A Screening visit
  • Visit 1: for blood sampling specifically for the study The Screening visit and the Visit 1 could occur on the same day.
Procedure: blood collection
Blood sampling is performed during Scrrening / visit 1 for patients enrolled in cohort 1, cohort 2 and cohort 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of circulating and infiltrating tumor cells .
Time Frame: From screening to end of study at 8 weeks
Caracterization of tumor cells immuno-phenotyping and gene signature.
From screening to end of study at 8 weeks

Collaborators and Investigators

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

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Principal Investigator: Frederic VELY, Dr, Assistance Publique Hopitaux de Marseille

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 (Estimated)

April 30, 2025

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

August 28, 2024

First Submitted That Met QC Criteria

February 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 13, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCAPHM23-0388
  • 2023-A02198-37 (Registry Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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