Exploring endothelial cell dysfunction in blood cancers
The Endothelial Cell Dysfunction and Outcome Project for Hematological Neoplasms (EndoCDO-H). A Prospective Registry Study on Endothelial Functional Profile, Intervention Type and Clinical Outcome in Patients With Hematological Neoplasms
University Hospital Heidelberg · NCT05502887
This study is trying to see how blood cancer treatments affect the tiny blood vessel cells in patients and if this can help predict complications and improve care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Heidelberg (other) |
| Drugs / interventions | CART |
| Locations | 1 site (Heidelberg, Baden-Wurttemberg) |
| Trial ID | NCT05502887 on ClinicalTrials.gov |
What this trial studies
This observational project investigates the role of endothelial cell dysfunction in patients with hematological neoplasms. It focuses on understanding how anti-neoplastic and immune therapies affect the endothelial layer and the associated risks of endothelial complications. The study utilizes sublingual in vivo microscopy with the Glycocheck microscope to assess endothelial vulnerability markers and their prognostic significance for treatment-related mortality. By examining the relationship between endothelial activation and stress index (EASIX) and patient outcomes, the research aims to enhance diagnostic criteria for endothelial complications following hematological therapies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a suspected or confirmed diagnosis of hematological neoplasms.
Not a fit: Patients with severe neurological or psychiatric disorders that impair their ability to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management and outcomes of patients with hematological neoplasms by identifying critical biomarkers for endothelial dysfunction.
How similar studies have performed: While the concepts of endothelial vulnerability and dysfunction have been explored in previous studies, this specific approach using EASIX and in vivo microscopy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Suspected or proven diagnosis of hematological neoplasms according to the WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues; * Age ≥18 years; * Ability to understand nature and individual consequences of the registry; * Written informed consent; * Subjects who are physically or mentally capable of giving consen. Exclusion Criteria: \- Severe neurological or psychiatric disorder interfering with the ability to give written informed consent.
Where this trial is running
Heidelberg, Baden-Wurttemberg
- Department of Internal Medicine V, Heidelberg University Hospital — Heidelberg, Baden-Wurttemberg, Germany (RECRUITING)
Study contacts
- Principal investigator: Prof. Dr. Thomas Luft — Heidelberg University
- Study coordinator: Prof. Dr. Thomas Luft
- Email: Thomas.Luft@med.uni-heidelbe
- Phone: +49 06221/56 8030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hematological Neoplasm, Endothelial Dysfunction, endothelial cells, biomarkers, endothelial activation and stress index, endothelial complications, non-relapse mortality, in vivo microscopy