Collection of Blood and Bone Marrow From Patients With Ap... | NCT01680055

Studies
Collection of Blood and Bone Marrow From Patients With Aplastic Anemia for Analysis of Adhesion Molecules, Chemokines and Their Receptors

NCT01680055

Sponsor

Shandong University

Status

Withdrawn

Last Update Posted

Apr 20, 2016Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Aplastic Anemia
Healthy

Interventions

Not provided

Countries

China

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 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No eligible patient was enrolled.

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Not provided

Completion Date

Nov 2012Estimated

First Submitted Date

Sep 3, 2012

First Submission Date that Met QC Criteria

Sep 3, 2012

First Posted Date

Sep 6, 2012Estimated

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

Apr 18, 2016

Last Update Posted Date

Apr 20, 2016Estimated

Description Module

Brief Summary

This study is designed to collect bone marrow and/or peripheral blood cells and plasma, for the analysis of adhesion molecules, chemokines and their receptors from newly-diagnosed aplastic anemia patients, and patients treated with antithymocyte globulin plus cyclosporine

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AA-ATG		Acquired Aplastic Anemia Patients Treated with Antithymocyte Globulin plus Cyclosporine

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hematologic response	hematologic response at 6 months following antithymocyte globulin plus cyclosporine treatment, defined as no longer meeting the criteria for severe aplastic anemia	6 months following antithymocyte globulin plus cyclosporine treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who fulfilled entry criteria of acquired aplastic anemia age range 16-70 years

Exclusion Criteria:

Patients complicated with diabetes, tumor, pregnancy, active infection, or connective tissue diseases, such as systemic lupus erythematosus.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients With Aplastic Anemia

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Qilu Hospital, Shandong University		Jinan	Shandong	250012	China

Condition Browse Module

MeSH Terms

ID	Term
D000741	Anemia, Aplastic

Ancestor Terms

ID	Term
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D000080983	Bone Marrow Failure Disorders

Browse Leaves

Not provided

Browse Branches

Not provided