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

NCT06827639 | Not Yet Recruiting

• 2 other identifiers: RCAPHM23-03882023-A02198-37
• Study Type: observational
• Target: 640
• Locations: 1 country
• Sites: 1

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\'s clinical features. The analyses generated will contribute to the design and improvement of innovative therapeutic antibodies acting on the immune system

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

Outcome Measures

Primary Outcomes (1)

• Identification of circulating and infiltrating tumor cells .

  Caracterization of tumor cells immuno-phenotyping and gene signature.

  From screening to end of study at 8 weeks

Study Arms (3)

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; Procedure: tissue specimen collection

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

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

Interventions

blood collection PROCEDURE

Blood sampling is performed during Scrrening / visit 1 for patients enrolled in cohort 1, cohort 2 and cohort 3

Cohort 1 - Patients with solid tumor undergoing surgery; Cohort 2 - Patients with solid tumor with anti-PD1/PD-L1 treatment and no surgery; Cohort 3 - Patients with hematological malignancies

tissue specimen collection PROCEDURE

In Cohort 1- patients with solid tumor undergoing surgery, fresh tissue specimen is collected during surgery

Cohort 1 - Patients with solid tumor undergoing surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Hopital Timone enfants - plateforme d'Immunoprofiling

Marseille, 13385, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Blood samples will be retained for phenotyping by flow cytometry, immune cells isolation for functional tests, nucleic acids extraction, cell freezing and storage, serum, plasma and PBMC preparation, freezing and storage * Fresh tissues from surgical resections will be obtained according to planned, standard medical practice. Remaining biological material only will be used and retained for tissue sample dissociation, ex vivo functional assays, tissue freezing or fixation and storage

MeSH Terms

Conditions

Head and Neck Neoplasms; Urologic Neoplasms; Lung Neoplasms; Breast Neoplasms; Liver Neoplasms; Stomach Neoplasms; Lymphoma; Leukemia

Interventions

Blood Specimen Collection; Tissue Banks

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Biological Specimen Banks; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Frederic VELY, Dr

  Assistance Publique Hôpitaux de Marseille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederic VELY, Dr

CONTACT

0491384396; frederic.vely@ap-hm.fr

Mathilde LEFEVRE,, Director

CONTACT

0491382778; mathilde.lefevre@ap-hm.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: February 14, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)