NCT01420172

Brief Summary

This will be a retrospective study and analysis of subjects who have undergone a hematopoietic stem transplant (either at OSUMC or external location) and were seen at OSUMC at any time between 01Jan2000 and 30Jun2011. This study will determine factors influencing pulmonary disease and associated treatment strategies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

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

August 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2011

Completed
4.9 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

October 1, 2015

Enrollment Period

4.9 years

First QC Date

August 16, 2011

Last Update Submit

February 24, 2017

Conditions

Post Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

  • A retrospective diagnostic review on pulmonary disease related to hematopoietic stem cell transplantation.

    To determine factors influencing pulmonary disease related to HSCT.

    Up to 15 years

Secondary Outcomes (1)

  • A retrospective treatment review on treatment strategies for pulmonary disease related to hematopoietic stem cell transplantation.

    Up to 15 years

Study Arms (1)

Post hematopoietic stem cell transplantation

Patients who were seen post hematopoietic stem cell transplantation between 01Jan2000 and 30Jun2011

Other: Data Collection

Interventions

Data CollectionOTHER

Collection of data on patients who were seen at OSUMC at any time between 01Jan2000 and 30Jun2011 post hematopoietic stem cell transplantation

Post hematopoietic stem cell transplantation

Eligibility Criteria

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

A patient record captured during 01Jan2000 and 30Jun2011 from the medical record at The Ohio State University Medical Center who were seen post hematopoietic stem transplant.

You may qualify if:

  • Adult patients who have undergone a hematopoietic stem transplant (either at OSUMC or external location) and were seen at OSUMC at any time between 01Jan2000 and 30Jun2011.
  • Age \> 18 years

You may not qualify if:

  • Age \<18 years
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43221, United States

Location

Related Publications (5)

  • Afessa B, Litzow MR, Tefferi A. Bronchiolitis obliterans and other late onset non-infectious pulmonary complications in hematopoietic stem cell transplantation. Bone Marrow Transplant. 2001 Sep;28(5):425-34. doi: 10.1038/sj.bmt.1703142.

    PMID: 11593314BACKGROUND

  • Williams KM, Chien JW, Gladwin MT, Pavletic SZ. Bronchiolitis obliterans after allogeneic hematopoietic stem cell transplantation. JAMA. 2009 Jul 15;302(3):306-14. doi: 10.1001/jama.2009.1018.

    PMID: 19602690BACKGROUND

  • Dudek AZ, Mahaseth H, DeFor TE, Weisdorf DJ. Bronchiolitis obliterans in chronic graft-versus-host disease: analysis of risk factors and treatment outcomes. Biol Blood Marrow Transplant. 2003 Oct;9(10):657-66. doi: 10.1016/s1083-8791(03)00242-8.

    PMID: 14569562BACKGROUND

  • Verleden GM, Vanaudenaerde BM, Dupont LJ, Van Raemdonck DE. Azithromycin reduces airway neutrophilia and interleukin-8 in patients with bronchiolitis obliterans syndrome. Am J Respir Crit Care Med. 2006 Sep 1;174(5):566-70. doi: 10.1164/rccm.200601-071OC. Epub 2006 Jun 1.

    PMID: 16741151BACKGROUND

  • Vos R, Vanaudenaerde BM, Verleden SE, De Vleeschauwer SI, Willems-Widyastuti A, Van Raemdonck DE, Schoonis A, Nawrot TS, Dupont LJ, Verleden GM. A randomised controlled trial of azithromycin to prevent chronic rejection after lung transplantation. Eur Respir J. 2011 Jan;37(1):164-72. doi: 10.1183/09031936.00068310. Epub 2010 Jun 18.

    PMID: 20562124BACKGROUND

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 16, 2011

First Posted

August 19, 2011

Study Start

August 1, 2011

Primary Completion

July 8, 2016

Study Completion

July 8, 2016

Last Updated

February 27, 2017

Record last verified: 2015-10

Locations

US(1)