Clinical trial NCT06827639: In-depth Characterization of Circulating and Infiltrating Immune Subsets and Tumor Cells in Cancer Patients
Official title: In-depth Characterization of Circulating and Infiltrating Immune Subsets and Tumor Cells in Cancer Patients.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Head and Neck Cancer
Urologic Cancer
Lung Cancer
Breast Cancer
Liver Cancer
Keywords: Tumor microenvironment
Immuno-phenotyping
Immunohistochemistry
Ex-vivo functional assays
circulating tumor DNA
Gene sinatures
Breast cancer
Head and neck cancer
Urologic cancer
Liver cancer
Colorectal and gastric cancer
Lung cancer
lymphoma
leukemia
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 640
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient from hospitals in Assistance Public Hopitaux de Marseille : Nord, Conception and Timone

Brief summary: 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\&#39;s clinical features. The analyses generated will contribute to the design and improvement of innovative therapeutic antibodies acting on the immune system

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

Eligibility criteria: 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

Primary outcomes:
measure: Identification of circulating and infiltrating tumor cells .
timeFrame: From screening to end of study at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital Timone enfants - plateforme d&#39;Immunoprofiling
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Frederic VELY, Dr
role: PRINCIPAL_INVESTIGATOR
References: