Citrulline Allo. Evaluation of Citrullinemia as a Marker... | NCT00751452

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

NCT00751452

Sponsor

University Hospital, Clermont-Ferrand

Status

Unknown status

Last Update Posted

Jan 19, 2011Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Benign Disease

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Sep 2009Estimated

Completion Date

Sep 2009Estimated

First Submitted Date

Sep 9, 2008

First Submission Date that Met QC Criteria

Sep 11, 2008

First Posted Date

Sep 12, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2011

Last Update Posted Date

Jan 19, 2011Estimated

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Citrullinemia (weekly)		weekly

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

screening

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lacarin Patrick	Contact			placarin@chu-clermontferrand.fr

Overall Officials

Name	Affiliation	Role
Merlin Etienne, Dr	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Etienne MERLIN	Recruiting	Clermont-Ferrand		63003	France

Condition Browse Module

MeSH Terms

ID	Term
D006086	Graft vs Host Disease

Ancestor Terms

ID	Term
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided