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Status unknownNCT01307241Updated Nov 15, 2013

RFC and MTHFR SNPs & hENT1- dCK Expression as Prognostic Factors in ALL & hENT1- dCK Expression as Prognostic Factors in AML

An observational study in Acute Lymphoblastic Leukemia. and Acute Myeloblastic Leukemia, sponsored by National Institute of Cancerología. Status unknown at 1 site in Mexico. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2013-11-15.

Sponsored by National Institute of Cancerología · Observational

The sponsor has not verified this record recently (last verified Nov 2013), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
15 Years and older
Sex
All
01

Study summary

Results of actual treatment in ALL are not optimal. New prognostic factors, which may determine clinical \& molecular response are required. Hyper-CVAD is an internationally accepted schema for such patients. The objective of this pilot study is to evaluate polymorphisms regarding RFC (reduced folate carrier) and MTHFR enzyme, which may affect the function of these proteins, and therefore the intracellular bioavailability of methotrexate. Also, the expression levels of hENT1 and dCK will be evaluated, since such genes codify for citarabine intracellular transport and activation, respectively. Clinical characteristics will be tabulated and analyzed for responders \& non-responders patients. Uni- \& multivariate analysis will be done to evaluate factors influencing on response and survival.

02

Conditions studied

  • Acute Lymphoblastic Leukemia.
  • Acute Myeloblastic Leukemia

Keywords

  • Acute lymphoblastic leukemia
  • prognostic factor
  • pharmacogenetics.
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 50 is below the median of 120 across 744 observational studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

National Institute of Cancerología is the lead sponsor of 38 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with acute lymphoblastic leukemia

Inclusion criteria

  • Age: older than 15 years.
  • Male, female.
  • Normal renal \& liver functions.
  • Without previous treatment.
  • Candidate to be treated with hyperCVAD Schema (ALL patients).
  • Candidate to receive induction remission with cytarabine (AML patients)

Exclusion criteria

Exclusion Criteria:

  • Patients not candidate to receive methotrexate or cytarabine.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • one cohort

    Adult patients with ALL attending at the Instituto Nacional de Cancerologia Mexico.

06

What researchers measure

Primary outcomes

  1. To evaluate clinical response

    To evaluate clinical response after ending Hyper-CVAD schema for ALL patients. To evaluate clinical response \& DFS in relation with hENT1 \& dCK expression levels in AML patients.

    Time frame: December 2012

  2. Clinical responses in relation with SNP's or gene expression

    Time frame: clinical response.

07

Study locations

1 site
  • Instituto Nacional de Cancerologia
    Mexico city, DF 14080, Mexico
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01307241
Lead sponsor
National Institute of Cancerología
Responsible party
DR. MYRNA CANDELARIA (Clinical researcher., National Institute of Cancerología) — Principal investigator
First posted
Mar 2, 2011
Start date
Dec 2010
Primary completion
Dec 2014 (estimated)
Completion
Dec 2015 (estimated)
Last update
Nov 15, 2013

Study contacts

myrna candelaria, md
principal investigator · Instituto Nacional de Cancerología Mexico

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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