Post Hematopoietic Stem Cell TransplantationNCT01420172
Pulmonary Disease in Patients Undergoing Hematopoietic Stem Cell Transplantation
An observational study of Post Hematopoietic Stem Cell Transplantation, run by Karen Wood at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Hematopoietic Stem Cell Transplantation
- What is being tested?
- Data Collection
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to 8 Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Age <18 years
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Medical Center
Columbus, Ohio, 43221
About this study
Official title: Pulmonary Disease in Patients Undergoing Hematopoietic Stem Cell Transplantation.
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.
- Being tested
- Data Collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data CollectionOther
Collection of data on patients who were seen at OSUMC at any time between 01Jan2000 and 30Jun2011 post hematopoietic stem cell transplantation
| Study group | Role | What they receive |
|---|---|---|
| Post hematopoietic stem cell transplantation | Patients who were seen post hematopoietic stem cell transplantation between 01Jan2000 and 30Jun2011 Receives: Other: Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
A retrospective diagnostic review on pulmonary disease related to hematopoietic stem cell transplantation.
To determine factors influencing pulmonary disease related to HSCT.
Measured: Up to 15 years
Secondary outcomes (1)
A retrospective treatment review on treatment strategies for pulmonary disease related to hematopoietic stem cell transplantation.
To review treatment strategies for pulmonary disease post transplant for effectiveness.
Measured: Up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startAug 2011
- Primary completion8 Jul 2016
- Study completion8 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Post Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karen Wood
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Karen Wood, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420172
- Sponsor's protocol ID
- 2011H0214
- Status last verified
- Oct 2015
- First submitted
- 16 Aug 2011
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11593314Williams 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.
PubMed 19602690Dudek 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.
PubMed 14569562Verleden 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.
PubMed 16741151Vos 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.
PubMed 20562124
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Disease in Patients Undergoing Hematopoietic Stem Cell Transplantation.
- ClinicalTrials.gov ID
- NCT01420172
- Acronym / sponsor ID
- 2011H0214
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Karen WoodUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- 8 Jul 2016 (actual)
- Study completion
- 8 Jul 2016 (actual)
- First posted
- 19 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post hematopoietic stem cell transplantation | – | Other: Data CollectionPatients who were seen post hematopoietic stem cell transplantation between 01Jan2000 and 30Jun2011 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Age <18 years
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data CollectionCollection of data on patients who were seen at OSUMC at any time between 01Jan2000 and 30Jun2011 post hematopoietic stem cell transplantation | Other | Post hematopoietic stem cell transplantation |
Primary outcome
A retrospective diagnostic review on pulmonary disease related to hematopoietic stem cell transplantation.
Time frame: Up to 15 years
To determine factors influencing pulmonary disease related to HSCT.
1 secondary outcome
A retrospective treatment review on treatment strategies for pulmonary disease related to hematopoietic stem cell transplantation.
Time frame: Up to 15 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Background: PubMed 11593314Afessa 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.
- Background: PubMed 19602690Williams 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.
- Background: PubMed 14569562Dudek 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.
- Background: PubMed 16741151Verleden 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.
- Background: PubMed 20562124Vos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Hematopoietic Stem Cell Transplantation, run by Karen Wood at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A retrospective diagnostic review on pulmonary disease related to hematopoietic stem cell transplantation. (time frame: Up to 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01420172, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017.