Citrulline Allo. Evaluation of Citrullinemia as a Marker of Bowel Damage After Allogeneic Bone Marrow Transplantation in Children

January 18, 2011 updated by: University Hospital, Clermont-Ferrand

Evaluation of Citrullinemia as a Marker of Bowel Damage After Allogeneic Bone Marrow Transplantation in Children

determine the interest of the dosage of citrullinemia to monitor the bowel damage after allogeneic bone marrow transplantation in children.

Study Overview

Status

Unknown

Conditions

Detailed Description

30 children included. Dosage of citrullinemia on day -7, day 0 and every week up to 100 days after BMT. Histological examination and extensive infectious screening in case of persistent digestive symptoms (more than 3 days).

Two groups of patients regarding on digestive involvement. Comparison of the values of citrullinemia between these two groups.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • Etienne MERLIN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

screening

Description

Inclusion Criteria:

  • 0 to 18 years
  • allogeneic bone marrow transplantation for malignant or benign disease
  • affiliation to French sécurité sociale
  • parent's consent

Exclusion Criteria:

  • severe gastro-intestinal involvement before transplant
  • previous digestive surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Citrullinemia (weekly)
Time Frame: weekly
weekly

Secondary Outcome Measures

Outcome Measure
Time Frame
Gastro-intestinal complications in children following allogeneic bone marrow transplantation
Time Frame: following allogenic bone marrow transplantation
following allogenic bone marrow transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Merlin Etienne, Dr, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Anticipated)

September 1, 2009

Study Completion (Anticipated)

September 1, 2009

Study Registration Dates

First Submitted

September 9, 2008

First Submitted That Met QC Criteria

September 11, 2008

First Posted (Estimate)

September 12, 2008

Study Record Updates

Last Update Posted (Estimate)

January 19, 2011

Last Update Submitted That Met QC Criteria

January 18, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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