NCT05049148

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
41mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Oct 2022Oct 2029

First Submitted

Initial submission to the registry

August 18, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 17, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 27, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

3.9 years

First QC Date

August 18, 2021

Last Update Submit

December 30, 2025

Conditions

Keywords

Platelets activation

Outcome Measures

Primary Outcomes (1)

  • Platelet detection in excised brain/medurally tumors

    biopsy: Presence of neo-vessels

    1 hour

Study Arms (1)

Patients requirering brain/medullary tumors excision

OTHER

All patients requirering a surgery for brain or medullar excision

Other: Platelet count in excised tumors

Interventions

Tumors excised in patients requirering a brain or medullary surgery will be assess to determine their platelet count.

Patients requirering brain/medullary tumors excision

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Tumor sample volume not allowing the performance of additional analyzes
  • Patient benefiting from a legal protection measure
  • Pregnant or breastfeeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation A De Rothschild

Paris, France

RECRUITING

MeSH Terms

Conditions

GliomaInflammationBrain Neoplasms

Interventions

Platelet Count

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissuePathologic ProcessesPathological Conditions, Signs and SymptomsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Blood Cell CountCell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsPlatelet Function TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Pierre BOURDILLON, MD

    Fondation A. de Rothschild

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amélie YACHITZ, MD

CONTACT

Vivien VASSEUR

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2021

First Posted

September 17, 2021

Study Start

October 27, 2022

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2029

Last Updated

January 5, 2026

Record last verified: 2025-12

Locations