NCT00837681

Brief Summary

The purpose of this study is to determine risk factors associated with the development of lung disease after hematopoietic stem cell transplantation. Depending on the results and findings of this study, it may be possible to predict who is at higher risk of serious complications and ultimately develop therapies to prevent or treat this lung disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2009

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2016

Completed
Last Updated

February 27, 2017

Status Verified

July 1, 2016

Enrollment Period

10.8 years

First QC Date

February 4, 2009

Last Update Submit

February 24, 2017

Conditions

Lung Disease

Keywords

Bone Marrow Transplanthematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

  • To determine factors contributing to the development of lung disease after hematopoietic stem cell transplantation (HSCT

    end of study

Secondary Outcomes (1)

  • 1b) To identify the mechanisms by which CD8+ regulatory cells suppress the alloimmune response.

    end of study

Study Arms (1)

lung disease

hematopoietic stem cell transplantation (HSCT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients scheduled to undergo hematopoietic stem cell transplantation (HSCT)

You may qualify if:

  • \. All patients scheduled to undergo hematopoietic stem cell transplantation (HSCT)

You may not qualify if:

  • Patients whose ability to give informed consent is in question.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood draw will be 10cc of blood, analysis includes % of CD8+CD57+ and CD8+CD28-. On one occasion, after the 6 mo. post transplant timepoint the subject will be asked to donate a larger amount of blood (50cc) if they are not anemic. \*\*\*Respiratory Specimens of extra BAL or biopsy specimens will be collected at any point a study patient undergoes a clinically warranted bronchoscopy or lung biopsy procedure and the diagnostic physician feels there is adequate specimen to use extra sample for research purposes.

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Karen Wood, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Karen Wood M.D.

Study Record Dates

First Submitted

February 4, 2009

First Posted

February 5, 2009

Study Start

October 1, 2005

Primary Completion

July 8, 2016

Study Completion

July 8, 2016

Last Updated

February 27, 2017

Record last verified: 2016-07

Locations

US(1)