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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00822432
Other study ID # P061005
Secondary ID
Status Completed
Phase N/A
First received January 13, 2009
Last updated July 30, 2012
Start date October 2007
Est. completion date August 2011

Study information

Verified date January 2009
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial Summary

High dose methotrexate (MTX) is responsible of severe toxicity in patients in whom elimination from plasma is delayed. Factors responsible for MTX accumulation are partly known but some patients still experience toxicity despite adequate measures being taken. Our hypothesis is that renal tubular secretion may be impaired in these patients. This study aims at evaluating the performance of the UCP ratio (urinary ratio of coproporphyrins), a putative biomarker of tubular secretion, in predicting delayed MTX elimination.


Description:

MTX is a substrate of MRP2, a renal tubular transporter encoded by the ABCC2 gene. It has been shown that single nucleotide polymorphisms (SNPs) on the ABCC2 gene are associated with impairment of MTX elimination. Mutations on the ABCC2 gene are also responsible for the Dubin-Johnson syndrome, characterised by the absence of a functional MRP2 protein. Apart from hyperbilirubinaemia, the main biological perturbation observed in this disease is a typical increase of the urinary ratio of coproporphyrins I (I+ III) (UCP ratio). Our hypothesis is that the UCP ratio could be used as a biomarker of MRP2's activity, thus predicting MTX elimination. One hundred patients treated with high dose MTX will be recruited in this prospective study. Their UCP ratio will be measured before and after MTX administration and correlated with MTX clearance. A genetic analysis will be conducted to study the five more frequents SNPs of ABCC2 in each patient.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria :

- Patients receiving HDMTX (=1g/m2) for a primitive cerebral lymphoma, a large cell lymphoma, a lymphoblastic lymphoma, a Burkitt's lymphoma or an acute lymphoblastic leukaemia,

- over 18 years old,

- Signed informed consent.

- Affiliated to a medical assurance.

- Able to respect the protocol.

- Effective contraception for women.

Exclusion criteria :

- renal failure,

- liver failure,

- hepatic cytolysis,

- chronic respiratory deficiency,

- pregnancy,

- breast-feeding,

- Concomitant medication: phenytoin, probenecid, trimethoprim, phenylbutazone, salicylates, non steroid anti-inflammatory, yellow fever vaccine.

- Patient included in another study in the four weeks preceding his inclusion.

Study Design

Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
France Pitié-Salpêtrière Hospital Paris
France University Hospital Centre of Tours Tours

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary MTX concentrations at the end of MTX infusion and every 24-hours until concentrations reach 0,2µM. Yes
Secondary The UCP I/(I+III) ratio before and at the end of MTX infusion and at the end of hospitalisation. Yes
Secondary Five polymorphisms of the ABCC2 gene (-24C/T, 1249G/A, 3563T/A, 4544G/A) during the study Yes
Secondary Blood cells count . before MTX infusion and at the end of hospitalisation Yes
Secondary Renal function before MTX infusion and at the end of hospitalisation Yes
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