Analysis of Genetic Factors Related to Predisposition and... | NCT00159003

Studies
Analysis of Genetic Factors Related to Predisposition and Prognosis of Hematological Malignancies in Israel

NCT00159003

Sponsor

Deborah Rund

Status

Completed

Last Update Posted

Aug 10, 2017Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Acute Myeloid Leukemia
Chronic Lymphocytic Leukemia
Chronic Myelogenous Leukemia

Interventions

Not provided

Countries

Israel

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

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 1998Actual

Primary Completion Date

Jul 1, 2017Actual

Completion Date

Jul 1, 2017Actual

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 8, 2005

First Posted Date

Sep 12, 2005Estimated

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

Aug 9, 2017

Last Update Posted Date

Aug 10, 2017Actual

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

There are naturally occuring variations in the genetic makeup of all of us. Some of these variations may contribute to a change in susceptibility toward different diseases or change the prognosis.

We are studying these genetic variations in patients with leukemia. The genes we are studying are those which influence detoxification of drugs and toxins.

Detailed Description

We have prepared DNA on patients with leukemia (AML, CML and CLL) and we are studying the influence of polymorphisms in drug metabolism and disposition genes on predisposition and prognosis of these types of leukemia. The genes we are studying include: MDR1, CYP3A4, NQO1, NAT1/2, GST, hOCT. We plan to study other genes that may be contributory.

Study includes comparing the frequency of polymorphisms in these genes with the frequency in the general population and the study of DNA biding proteins which bind at the sites of these polymorphisms.

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

Retention

Enrollment

100Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of acute myeloid leukemia or chronic lymphocytic leukemia

Exclusion Criteria:

under 18 years of age

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients admitted to Hadassah Hospital with AML or CLL.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Deborah G Rund, MD	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization		Jerusalem		IL91120	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14582082	Background	Chanock S. Genetic variation and hematology: single-nucleotide polymorphisms, haplotypes, and complex disease. Semin Hematol. 2003 Oct;40(4):321-8. doi: 10.1016/s0037-1963(03)00198-7.

ID	Term
D015470	Leukemia, Myeloid, Acute
D015451	Leukemia, Lymphocytic, Chronic, B-Cell
D015464	Leukemia, Myelogenous, Chronic, BCR-ABL Positive

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms