NCT02254798

Brief Summary

Validation of already described biomarkers on acute GVHD prediction and severity Fecal calprotectin and alpha 1 anti-trypsin, plasmatic RER3a, IL-8, Elafin, TNFaR1, IL-2R alpha, HGF

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
315

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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 Start

First participant enrolled

January 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 2, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 2, 2014

Status Verified

September 1, 2014

Enrollment Period

3.4 years

First QC Date

September 17, 2014

Last Update Submit

September 29, 2014

Conditions

Acute GVH Disease

Outcome Measures

Primary Outcomes (2)

  • Number of patients with an Acute Graft-versus-Host disease

    Evaluation of fecal and plasmatic markers as diagnostic markers of GVHD

    The 6 first months after transplantation

  • Number of patients with an Acute Graft-versus-Host disease refractory to steroids

    to evaluate the potential of these markers as risk factors for steroid-refractory acute GVHD occurrence

    14 days after acute graft-versus-host disease

Study Arms (1)

Transplanted patients

No intervention Prospective registration of patients receiving an allogeneic hematopoietic stem cell transplant

Other: no intervention

Interventions

no interventionOTHER

this is a non interventional study

Transplanted patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adult patients receiving an allogeneic transplant

You may qualify if:

  • adult patients receiving an allogeneic transplant
  • informed consent signed

You may not qualify if:

  • patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Saint-Louis

Paris, France

RECRUITING

Hôpital Saint-Louis

Paris, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood sample on day 7, 14, 21, 28 and at GVHD onset

Study Officials

  • Marie Robin

    Hôpital Saint-Louis

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Robin, MD, PhD

CONTACT

33142494724marie.robin@sls.aphp.fr

marie-Hélène Schlageter, PHD

CONTACT

marie-helene.schlageter@sls.aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2014

First Posted

October 2, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

October 2, 2014

Record last verified: 2014-09

Locations

FR(2)