Platelets Activation in Brain Neoplasms (Platon)
Primary Purpose
Glioma, Blood Platelets, Inflammation
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Platelet count in excised tumors
Sponsored by
About this trial
This is an interventional other trial for Glioma focused on measuring Platelets activation
Eligibility Criteria
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
Sites / Locations
- Fondation A De RothschildRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients requirering brain/medullary tumors excision
Arm Description
All patients requirering a surgery for brain or medullar excision
Outcomes
Primary Outcome Measures
Platelet detection in excised brain/medurally tumors
biopsy: Presence of neo-vessels
Secondary Outcome Measures
Full Information
NCT ID
NCT05049148
First Posted
August 18, 2021
Last Updated
February 16, 2023
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
1. Study Identification
Unique Protocol Identification Number
NCT05049148
Brief Title
Platelets Activation in Brain Neoplasms
Acronym
Platon
Official Title
Observation of Platelets in Primary and Secondary Tumors of the Central Nervous System and Association With Survival: a Prospective Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2022 (Actual)
Primary Completion Date
January 20, 2025 (Anticipated)
Study Completion Date
January 20, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Detailed Description
This is a descriptive study that did not include any intervention other than tumor tissue preservation and blood sampling.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma, Blood Platelets, Inflammation, Brain Neoplasms
Keywords
Platelets activation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients requirering brain/medullary tumors excision
Arm Type
Other
Arm Description
All patients requirering a surgery for brain or medullar excision
Intervention Type
Other
Intervention Name(s)
Platelet count in excised tumors
Intervention Description
Tumors excised in patients requirering a brain or medullary surgery will be assess to determine their platelet count.
Primary Outcome Measure Information:
Title
Platelet detection in excised brain/medurally tumors
Description
biopsy: Presence of neo-vessels
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amélie YACHITZ, MD
Phone
(0)148036454
Ext
+33
Email
ayavchitz@for.paris
First Name & Middle Initial & Last Name or Official Title & Degree
Vivien VASSEUR
Phone
(0)148036440
Ext
+33
Email
vvasseur@for.paris
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre BOURDILLON, MD
Organizational Affiliation
Fondation A. de Rothschild
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondation A De Rothschild
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Bourdillon, MD
Email
pbourdillon@for.paris
First Name & Middle Initial & Last Name & Degree
Gregory Torkomian
Email
gtorkomian@for.paris
12. IPD Sharing Statement
Learn more about this trial
Platelets Activation in Brain Neoplasms
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