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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Lymphoblastic Leukemia. Acute Myeloblastic Leukemia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Acute lymphoblastic leukemia prognostic factor pharmacogenetics.

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

one cohort

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* Patients not candidate to receive methotrexate or cytarabine.

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

DR. MYRNA CANDELARIA

Clinical researcher.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

myrna candelaria, md

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Cancerología Mexico

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Instituto Nacional de Cancerologia

Mexico City, Mexico City, Mexico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Mexico

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

010/020/ICI

Identifier Type: -

Identifier Source: org_study_id