Investigation of the Cylex® ImmuKnow® Assay | NCT00569842

Studies
Investigation of the Cylex® ImmuKnow® Assay

NCT00569842

Sponsor

Indiana University

Status

Completed

Last Update Posted

Sep 11, 2014Estimated

Enrollment

45Actual

Phase

Not provided

Conditions

Leukemia
Non-Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
Hodgkin's Disease
Multiple Myeloma
Myelodysplastic Syndromes
Myeloproliferative Disorders
Aplastic Anemia
Chronic Myelogenous Leukemia

Interventions

Not provided

Countries

United States

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

Sep 2014

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

Nov 2007

Primary Completion Date

Feb 2010Actual

Completion Date

Dec 2012Actual

First Submitted Date

Dec 5, 2007

First Submission Date that Met QC Criteria

Dec 6, 2007

First Posted Date

Dec 7, 2007Estimated

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

Sep 10, 2014

Last Update Posted Date

Sep 11, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Currently, there is no accurate way of predicting the occurrence of Graft vs Host Disease (GvHD) or infection. The purpose of this study is to analyze blood with the ImmuKnow® Assay to see if doctors can detect which patients are at risk for GvHD and for getting an infection before they occur.

Detailed Description

Not provided

Conditions Module

Conditions

Leukemia
Non-Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
Hodgkin's Disease
Multiple Myeloma
Myelodysplastic Syndromes
Myeloproliferative Disorders
Aplastic Anemia
Chronic Myelogenous Leukemia

Keywords

Not provided

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

45Actual

Label	Type	Description	Intervention Names
observational

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who are undergoing allogeneic HSCT using a myeloablative preparative regimen for any of the following disorders are eligible:

Acute leukemia
Non-Hodgkin's Lymphoma
Chronic lymphocytic leukemia
Hodgkin's disease
Multiple myeloma
Myelodysplastic Syndromes
Myeloproliferative Disorders
Aplastic Anemia
Chronic myelogenous leukemia

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 who are undergoing allogeneic HSCT using a myeloablative preparative regimen for any of the following disorders are eligible:

Acute leukemia
Non-Hodgkin's Lymphoma
Chronic lymphocytic leukemia
Hodgkin's disease
Multiple myeloma
Myelodysplastic Syndromes
Myeloproliferative Disorders
Aplastic Anemia
Chronic myelogenous leukemia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sherif Farag, MD, PhD	Indiana University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Indiana Universtiy Simon Cancer Center		Indianapolis	Indiana	46202	United States

Condition Browse Module

MeSH Terms

ID	Term
D007938	Leukemia
D008228	Lymphoma, Non-Hodgkin
D015451	Leukemia, Lymphocytic, Chronic, B-Cell
D006689	Hodgkin Disease
D009101	Multiple Myeloma
D009190	Myelodysplastic Syndromes
D009196	Myeloproliferative Disorders
D000741	Anemia, Aplastic
D015464	Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided