RFC and MTHFR SNPs & hENT1- dCK Expression as Prognostic... | NCT01307241

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

NCT01307241

Sponsor

National Institute of Cancerología

Status

Unknown status

Last Update Posted

Nov 15, 2013Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Acute Lymphoblastic Leukemia.
Acute Myeloblastic Leukemia

Interventions

Not provided

Countries

Mexico

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

Nov 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Feb 28, 2011

First Submission Date that Met QC Criteria

Feb 28, 2011

First Posted Date

Mar 2, 2011Estimated

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

Nov 14, 2013

Last Update Posted Date

Nov 15, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

DR. MYRNA CANDELARIA, Clinical researcher., National Institute of CancerologíaPrincipal Investigator

Lead Sponsor

National Institute of CancerologíaOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
one cohort		Adult patients with ALL attending at the Instituto Nacional de Cancerologia Mexico.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	December 2012
Clinical responses in relation with SNP's or gene expression		clinical response.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with acute lymphoblastic leukemia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
myrna candelaria, md	Instituto Nacional de Cancerología Mexico	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Nacional de Cancerologia		Mexico City	Mexico City	14080	Mexico

Condition Browse Module

MeSH Terms

ID	Term
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D015470	Leukemia, Myeloid, Acute

Ancestor Terms

ID	Term
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided