NCT06022055

Brief Summary

The TIPI2 study is a blood and tissue collection protocol to create an annotated biorepository to support research in drug-resistant epilepsy. The aim of the study will be to identify new pathophysiological pathways. For this purpose, the investigators will investigate with a multimodal approach blood and brain samples from patients undergoing a surgery for focal drug-resistant epilepsy. The adult patients will be enrolled either during the pre-surgical evaluation or right before the surgery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
131mo left

Started Feb 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Feb 2024Feb 2037

First Submitted

Initial submission to the registry

May 22, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 1, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

February 29, 2024

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2030

Expected
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2037

Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

6 years

First QC Date

May 22, 2023

Last Update Submit

June 30, 2025

Conditions

Focal Drug-resistant Epilepsy

Keywords

Focal drug-resistant epilepsySurgeryBiorepositoryBiomarkers

Outcome Measures

Primary Outcomes (3)

  • Identification of new pathophysiological mechanisms leading to focal drug-resistant epilepsy : analysis by immuno-histological methods

    The investigator will identify inflammatory cells (astrocytes, microglia, lymphocytes and neutrophil polynuclear cells) in the post-operative brain tissue, and will calculate if there is an increase of a part of these cells in the area, defined as the seizure onset zone, as compared to the non-epileptic areas.

    At the day of surgery; analyses are based on the post-operative tissues

  • Identification of new pathophysiological mechanisms leading to focal drug-resistant epilepsy : analysis by electrophysiological methods

    The investigator will record local field potentials and neuronal firing rate from post-operative tissues, and we will research an increase of the rate of interictal epileptiform discharges and of the frequency of the neuronal firing in the seizure-onset zone, as compared to those in non-epileptic areas.

    At the day of surgery; analyses are based on the post-operative tissues

  • Identification of new pathophysiological mechanisms leading to focal drug-resistant epilepsy : analysis by RNA sequencing methods

    The investigator will measure the expression of mRNA in cells of different parts of the post-operative brain tissue, and we will research specific expression of mRNA in the Seizure onset zone, as compared to that in other non-epileptic areas.

    At the day of surgery; analyses are based on the post-operative tissues

Secondary Outcomes (4)

  • Identification of new pathophysiological mechanisms associated with the occurrence of a seizure : analysis of biomarkers by ELISA methods

    from inclusion day to 36 months after the surgery

  • Identification of new pathophysiological mechanisms associated with an active epilepsy : analysis of biomarkers by ELISA methods

    from inclusion day to 36 months after the surgery

  • Identification of new pathophysiological mechanisms associated with an active epilepsy : analysis of blood cell subtypes by flow cytometry

    from inclusion day to 36 months after the surgery

  • Identification of new pathophysiological mechanisms associated with an active epilepsy : analysis of inflammation biomarkers by digital ultra-sensitive quantitation of proteins methods

    from inclusion day to 36 months after the surgery

Study Arms (1)

epileptic patients

EXPERIMENTAL

All patients will be enrolled in the same arm. Patients can be enrolled during the pre-surgical evaluation (group 1) or in the days preceding the surgery (group 2).

Other: Blood and tissue collection

Interventions

Blood and tissue collectionOTHER

Blood will be collected for group 1 during (i) the enrolment visit, (ii) in the 24 hours following a seizure, (iii)before the surgery and (iv) in the 36 months following the surgery. The left-over tissue, not useful for diagnostic purpose, will be kept for research. Blood will be collected for group 2 right before the surgery and in the 36 months following the surgery. The left-over tissue not useful for diagnostic purpose will be kept for research.

epileptic patients

Eligibility Criteria

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

You may qualify if:

  • yo or above
  • patients with a focal drug-resistant epilepsy
  • patients hospitalized for a pre-surgical evaluation or for an epilepsy surgery
  • consent obtained from the patient, or legally authorized representative
  • affiliated to a social security system

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Epilepsy Unit, Pitié-Salpêtrière Hospital

Paris, 75013, France

RECRUITING

MeSH Terms

Interventions

Blood Specimen CollectionTissue Banks

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesBiological Specimen BanksHealth FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Vincent M. Navarro, MD, PHD

    APHP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent M. Navarro, MD, PHD

CONTACT

01 42 16 19 40Vincent.navarro@aphp.fr

Aurélie Ms Hanin, PharmD, PhD

CONTACT

01 57 27 40 56Aurelie.hanin@icm-institute.org

Study Design

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

Study Record Dates

First Submitted

May 22, 2023

First Posted

September 1, 2023

Study Start

February 29, 2024

Primary Completion (Estimated)

February 28, 2030

Study Completion (Estimated)

February 28, 2037

Last Updated

July 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor.
Access Criteria
Researchers who provide a methodologically sound proposal.

Locations

FR(1)