Head and Neck CancerFUTURENCT06827639
In-depth Characterization of Circulating and Infiltrating Immune Subsets and Tumor Cells in Cancer Patients
An observational study of Head and Neck Cancer and Urologic Cancer, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Urologic Cancer, Lung Cancer
- What is being tested?
- blood collection and tissue specimen collection
- Type of treatment
- Surgery or procedure
- How many people
- 640 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2025to 30 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient from hospitals in Assistance Public Hopitaux de Marseille : Nord, Conception and Timone
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hopital Timone enfants - plateforme d'Immunoprofiling
Marseille, 13385
Frederic VELY, Dr, 0491384396, frederic.vely@ap-hm.fr
About this study
Official title: 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
Read the 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
- Conditions
- Head and Neck Cancer, Urologic Cancer, Lung Cancer, Breast Cancer, Liver Cancer
- Being tested
- blood collection, tissue specimen collection
- 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
- Medical subject headings
- Head and Neck Neoplasms, Urologic Neoplasms, Lung Neoplasms, Breast Neoplasms, Liver Neoplasms, Stomach Neoplasms, Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood collectionProcedure or surgery
Blood sampling is performed during Scrrening / visit 1 for patients enrolled in cohort 1, cohort 2 and cohort 3
tissue specimen collectionProcedure or surgery
In Cohort 1- patients with solid tumor undergoing surgery, fresh tissue specimen is collected during surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of circulating and infiltrating tumor cells .
Caracterization of tumor cells immuno-phenotyping and gene signature.
Measured: From screening to end of study at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start30 Apr 2025 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic VELY, Dr, Principal investigator, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827639
- Sponsor's protocol ID
- RCAPHM23-0388
- Other IDs
- 2023-A02198-37
- Acronym
- FUTURE
- Status last verified
- Feb 2025
- First submitted
- 28 Aug 2024
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-depth Characterization of Circulating and Infiltrating Immune Subsets and Tumor Cells in Cancer Patients.
- ClinicalTrials.gov ID
- NCT06827639
- Acronym / sponsor ID
- FUTURE / RCAPHM23-0388
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 30 Apr 2025 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Patients with solid tumor undergoing surgery | – | Procedure: blood collection, Procedure: tissue specimen collectionCohort 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. |
| Cohort 2 - Patients with solid tumor with anti-PD1/PD-L1 treatment and no surgery | – | Procedure: blood collection* 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. |
| Cohort 3 - Patients with hematological malignancies | – | Procedure: blood collection- 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient from hospitals in Assistance Public Hopitaux de Marseille : Nord, Conception and Timone
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood collectionBlood sampling is performed during Scrrening / visit 1 for patients enrolled in cohort 1, cohort 2 and cohort 3 | Procedure or surgery | 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 collectionIn Cohort 1- patients with solid tumor undergoing surgery, fresh tissue specimen is collected during surgery | Procedure or surgery | Cohort 1 - Patients with solid tumor undergoing surgery |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frederic VELY, Dr principal investigator
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Urologic Cancer, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frederic VELY, Dr (0491384396, frederic.vely@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of circulating and infiltrating tumor cells . (time frame: From screening to end of study at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.