4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Lipopolysaccharide Metabolism and Identification of Potential Biomarkers Predictive of Graft-versus-host Disease After Allogeneic Stem Cell Transplantation (MetAlloLip)

Lipopolysaccharide Metabolism and Identification of Potential Biomarkers Predictive of Graft-versus-host Disease After Allogeneic Stem Cell Transplantation (MetAlloLip)

Study Description
Brief Summary:
This study is designed to assess the hypothesis that the lipopolysaccharide (LPS) activity index can be quantified early after transplantation, as well as the the PhosphoLipid Transfer Protein (PLTP) activity and these both biological variables are independent variables for predicting the risk of severe Graft versus Host Disease (GVHD).

Condition or disease Intervention/treatment Phase
Hematologic Diseases Stem Cell Transplantation Other: Blood sample Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Study of Lipopolysaccharide Metabolism for Identification of New Biomarkers Predictive of Graft-versus-host Disease After Allogeneic Stem Cell Transplantation
Actual Study Start Date : September 6, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : September 2022
Arms and Interventions
Arm Intervention/treatment
All patients Other: Blood sample
blood samples (4 times; 14ml per visit)
Outcome Measures
Primary Outcome Measures :
  1. Area under the ROC curve for PLTP in the occurrence of GVHD [ Time Frame: 3 months ]
    Area under the ROC curve (AUCROC) for PLTP assessed at day 0 (day of transplantation) in the occurrence of GVHD (grade II-IV) at 3 months post-transplant.

  2. Area under the ROC curve for LPS in the occurrence of GVHD [ Time Frame: 3 months ]
    Area under the ROC curve (AUCROC) for LPS assessed at day 0 (day of transplantation) in the occurrence of GVHD (grade II-IV) at 3 months post-transplant.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hematologic malignancy in complete remission
  • Patients eligible for allogeneic hematopoietic cell transplantation from a related or unrelated donor and after myeloablative or non-myeloablative conditioning.
  • Regular follow-up in the center

Exclusion Criteria:

  • Treatment with a statin in progress
  • Umbilical cord blood transplantation
  • Hemoglobin level less than or equal to 8g / dl
  • Known chronic inflammatory bowel disease or gastroenteritis at the time of inclusion.
  • Chronic enteropathy with Clostridium Difficile
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Charline Vauchy, PhD +33381218875 cvauchy@chu-besancon.fr

Locations
Layout table for location information
France
Centre Hospitalier Universitaire de Besançon Recruiting
Besançon, France, 25000
Contact: Etienne Daguindau, MCU-PH         
Centre Hospitalier Universitaire de Nancy Not yet recruiting
Nancy, France, 54 000
Contact: Marie-Thérèse Rubio, PU-PH         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
Layout table for investigator information
Principal Investigator: Etienne Daguindau, MD CHU Besançon
Tracking Information
First Submitted Date  ICMJE April 15, 2019
First Posted Date  ICMJE April 17, 2019
Last Update Posted Date February 1, 2021
Actual Study Start Date  ICMJE September 6, 2019
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2019)
  • Area under the ROC curve for PLTP in the occurrence of GVHD [ Time Frame: 3 months ]
    Area under the ROC curve (AUCROC) for PLTP assessed at day 0 (day of transplantation) in the occurrence of GVHD (grade II-IV) at 3 months post-transplant.
  • Area under the ROC curve for LPS in the occurrence of GVHD [ Time Frame: 3 months ]
    Area under the ROC curve (AUCROC) for LPS assessed at day 0 (day of transplantation) in the occurrence of GVHD (grade II-IV) at 3 months post-transplant.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lipopolysaccharide Metabolism and Identification of Potential Biomarkers Predictive of Graft-versus-host Disease After Allogeneic Stem Cell Transplantation
Official Title  ICMJE Study of Lipopolysaccharide Metabolism for Identification of New Biomarkers Predictive of Graft-versus-host Disease After Allogeneic Stem Cell Transplantation
Brief Summary This study is designed to assess the hypothesis that the lipopolysaccharide (LPS) activity index can be quantified early after transplantation, as well as the the PhosphoLipid Transfer Protein (PLTP) activity and these both biological variables are independent variables for predicting the risk of severe Graft versus Host Disease (GVHD).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Hematologic Diseases
  • Stem Cell Transplantation
Intervention  ICMJE Other: Blood sample
blood samples (4 times; 14ml per visit)
Study Arms  ICMJE All patients
Intervention: Other: Blood sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 15, 2019) 		98
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Hematologic malignancy in complete remission
  • Patients eligible for allogeneic hematopoietic cell transplantation from a related or unrelated donor and after myeloablative or non-myeloablative conditioning.
  • Regular follow-up in the center

Exclusion Criteria:

  • Treatment with a statin in progress
  • Umbilical cord blood transplantation
  • Hemoglobin level less than or equal to 8g / dl
  • Known chronic inflammatory bowel disease or gastroenteritis at the time of inclusion.
  • Chronic enteropathy with Clostridium Difficile
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Charline Vauchy, PhD +33381218875 cvauchy@chu-besancon.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03918343
Other Study ID Numbers  ICMJE P/2018/387
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Besancon
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Besancon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Etienne Daguindau, MD CHU Besançon
PRS Account Centre Hospitalier Universitaire de Besancon
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯