NCT00751452

Brief Summary

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

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

1 active site

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

April 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

January 19, 2011

Status Verified

January 1, 2011

Enrollment Period

1.4 years

First QC Date

September 9, 2008

Last Update Submit

January 18, 2011

Conditions

Benign Disease

Keywords

ChildrenAllogeneic bone marrow transplantationIntestinal damageCitrullineGraft versus Host Disease0 to 18 years old

Outcome Measures

Primary Outcomes (1)

  • Citrullinemia (weekly)

    weekly

Secondary Outcomes (1)

  • Gastro-intestinal complications in children following allogeneic bone marrow transplantation

    following allogenic bone marrow transplantation

Study Arms (2)

1

2

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

screening

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Etienne MERLIN

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Merlin Etienne, Dr

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lacarin Patrick

CONTACT

placarin@chu-clermontferrand.fr

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2008

First Posted

September 12, 2008

Study Start

April 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

January 19, 2011

Record last verified: 2011-01

Locations

FR(1)