NCT05333367

Brief Summary

The objective of this study is to describe the type of cell death induced by extracorporeal photochemotherapy, depending on the cell type, using a panel of complementary analysis techniques.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration 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

First Submitted

Initial submission to the registry

April 4, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

April 15, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

3.2 years

First QC Date

April 4, 2022

Last Update Submit

November 19, 2024

Conditions

Cutaneous T-Cell LymphomaGraft Vs Host DiseaseGraft Rejection

Keywords

Cell deathExtracorporeal Photochemotherapy

Outcome Measures

Primary Outcomes (3)

  • Type of cell death induced by 8-MOP sensitization and UVA irradiation

    Caspase-3 activation in Western blot

    24 hours

  • Type of cell death induced by 8-MOP sensitization and UVA irradiation

    Gasdermin D cleavage in Western blot

    24 hours

  • Type of cell death induced by 8-MOP sensitization and UVA irradiation

    MLKL (mixed lineage kinase domain-like pseudokinase) phosphorylation in Western blot

    24 hours

Study Arms (1)

Patients undergoing extracorporeal photochemotherapy

OTHER
Other: Samples collection

Interventions

Samples collectionOTHER

Sampling of 2 samples on the extracorporeal photochemotherapy circuit, before and after sensitization with 8-MOP and UVA irradiation (without additional puncture)

Patients undergoing extracorporeal photochemotherapy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients
  • Treated with ECP for at least 1 month, for control of GVHD in hematopoietic cell allograft (acute or chronic GVHD), treatment and control of cellular or humoral rejection in solid organ transplantation (heart, lung, kidney) or in the treatment of cutaneous T-cell lymphoma

You may not qualify if:

  • Subjects with limited legal capacity.
  • Subjects judged by the investigator to be unlikely to comply with study procedures
  • Subjects with no social security coverage.
  • Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Besançon

Besançon, 25000, France

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, CutaneousGraft vs Host Disease

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Charline VAUCHY, PhD

CONTACT

+33381218875cvauchy@chu-besancon.fr

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

April 4, 2022

First Posted

April 19, 2022

Study Start

April 15, 2022

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

November 21, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)