- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05049148
Platelets Activation in Brain Neoplasms (Platon)
Observation of Platelets in Primary and Secondary Tumors of the Central Nervous System and Association With Survival: a Prospective Cohort Study
Platelets are primarily known for their central role in primary hemostasis. However, they are increasingly recognized for their participation in various non-hemostatic processes, such as cancer progression and clinical expression. Experimental and clinical data indicate that the involvement of platelets in the pathophysiology of cancer goes far beyond the realm of cancer-associated thrombosis.
Several experimental studies have shown that platelets can promote the metastatic process by various mechanisms. However, while it has been shown in vitro that direct contact with platelets initiates tumor cells for metastasis, it remains unclear whether such contacts occur in solid tumors. In addition to their ability to promote metastasis, platelets have been shown to stimulate angiogenesis and play a crucial role in lymphangiogenesis.
Considering that blood vessels, lymphatics and immune cells are major components of the tumor ecosystem, our hypothesis is that platelets contribute to the development and / or regulation of the tumor microenvironment. This is because platelets stabilize tumor blood vessels by permanently repairing vascular damage caused by immune cells infiltrating tumors. Targeting platelets destabilizes tumor vessels, causing intra-tumor hemorrhage, which allows intra-tumor accumulation of intravenously administered anti-tumor drugs such as paclitaxel and improves their efficacy.
Studies have also reported the role of platelets in several pathogenic mechanisms of cancer: thrombocytosis is a paraneoplastic syndrome which suggests a poor prognosis in patients with solid tumors; a negative correlation between the platelet count and the response to chemotherapy has been reported in several types of cancer; histological analyzes of esophageal cancer suggested a possible association between the presence of platelets in the tumor stroma and the level of tumor lymphangiogenesis and lymphovascular invasion; finally, a recent study reported the expression of one of the main targets of immunotherapies, PD-L1, on the platelets of patients suffering from different types of solid cancers.
All of these data support our hypothesis that platelets are components and / or regulators of the tumor microenvironment and therefore potential targets for the improvement of anti-tumor therapies. In this context, the objectives of our project are to determine whether platelets are components of the microenvironment of tumors of the central nervous system, and to study the possible correlations between the intratumoral presence of platelets and the evolution of patients with central nervous system tumors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vivien VASSEUR
- Phone Number: +33 (0)148036440
- Email: vvasseur@for.paris
Study Contact Backup
- Name: Amélie YACHITZ, MD
- Phone Number: +33 (0)148036454
- Email: ayavchitz@for.paris
Study Locations
-
-
-
Paris, France
- Recruiting
- Fondation A de Rothschild
-
Contact:
- Pierre Bourdillon, MD
- Email: pbourdillon@for.paris
-
Contact:
- Gregory Torkomian
- Email: gtorkomian@for.paris
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient to undergo excision or biopsy of a brain or medullary tumor
- Patient over 18 years old
- Express consent to participate in the study
- Affiliate member of the Social Security system
Exclusion Criteria:
- Tumor sample volume not allowing the performance of additional analyzes
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
Study Plan
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: Patients requirering brain/medullary tumors excision
All patients requirering a surgery for brain or medullar excision
|
Tumors excised in patients requirering a brain or medullary surgery will be assess to determine their platelet count.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Platelet detection in excised brain/medurally tumors
Time Frame: 1 hour
|
biopsy: Presence of neo-vessels
|
1 hour
|
Collaborators and Investigators
Investigators
- Principal Investigator: Pierre BOURDILLON, MD, Fondation A. de Rothschild
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Pathological Conditions, Signs and Symptoms
- Inflammation
- Glioma
- Brain Neoplasms
- Investigative Techniques
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Cell Count
- Cytological Techniques
- Hematologic Tests
- Cell Physiological Phenomena
- Blood Physiological Phenomena
- Circulatory and Respiratory Physiological Phenomena
- Platelet Function Tests
- Blood Cell Count
- Platelet Count
Other Study ID Numbers
- PBN_2021_6
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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