Lung TransplantationNCT00816257
Lung Transplant Specimen Repository and Data Registry Protocol
An observational study of Lung Transplantation, run by Karen Wood at 1 site in United States.
Trial summary
All patients enrolled in the registry will be recipients of single and double lung transplantation (bilateral sequential, heart-lung, or living related donor grafts). During the routine management of lung recipients frequent surveillance of the lung allograft is necessary. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplantation
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Nov 2013
- 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: lung transplant recipients
Who may be able to join
- recipients of single and double lung transplantation (bilateral sequential, heart-lung, or living related donor grafts).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
All patients enrolled in the registry will be recipients of single and double lung transplantation (bilateral sequential, heart-lung, or living related donor grafts). During the routine management of lung recipients frequent surveillance of the lung allograft is necessary. This routinely involves: measurement of pulmonary functions, chest radiography, collection of peripheral blood to assess other organ function and monitor therapeutic drug levels, and bronchoscopic evaluation allowing for collection of lung lavage fluid and lung tissue biopsy. This surveillance normally follows a set schedule during the first one to two years following the transplant procedure. Surveillance is routinely performed at weeks 2, 8, 12, 24, 36, and 52 during the first year following the transplant procedure. Additional surveillance may be performed at any time when clinically indicated for the optimal management of the recipient. Information and specimens collected from each of these encounters will be entered in the data registry and specimen repository.
Read the detailed description
The collection of disposable lung allograft (transplant tissue samples), blood samples and information from medical records for storage, future analysis and research. Stored samples will be available to other researchers who have obtained separate review and approval from an ethics committee called an Institutional Review Board.
Immediately prior to the transplant surgery, the surgeon or pulmonologist will routinely examine the lungs via bronchoscopy during which subjects will be medicated for pain.
The samples that are obtained during this and post-surgery (clinically scheduled) bronchoscopies, including bronchial lavage, are either sent to pathology or are discarded if they do not qualify to go to pathology. For this research, the researchers are asking that the samples that do not qualify for pathology be placed into the repository instead of being thrown away.
- Conditions
- Lung Transplantation
- Keywords
- lung tissue repository
What is being measured
The primary outcome is the main question the study is designed to answer.
data registry and lung tissue repository
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2009 (estimated)
- Study startNov 2005
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karen Wood
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Karen Wood, Ohio State University
- Investigators
- David Nunley, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816257
- Sponsor's protocol ID
- 2005H0101
- Status last verified
- Nov 2013
- First submitted
- 31 Dec 2008
- Last updated
- 20 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Transplant Specimen Repository and Data Registry Protocol
- ClinicalTrials.gov ID
- NCT00816257
- Acronym / sponsor ID
- 2005H0101
- Conditions
- Lung Transplantation
- Keywords
- lung tissue repository
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Karen WoodUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 1 Jan 2009 (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.
All patients enrolled in the registry will be recipients of single and double lung transplantation (bilateral sequential, heart-lung, or living related donor grafts). During the routine management of lung recipients frequent surveillance of the lung allograft is necessary. This routinely involves: measurement of pulmonary functions, chest radiography, collection of peripheral blood to assess other organ function and monitor therapeutic drug levels, and bronchoscopic evaluation allowing for collection of lung lavage fluid and lung tissue biopsy. This surveillance normally follows a set schedule during the first one to two years following the transplant procedure. Surveillance is routinely performed at weeks 2, 8, 12, 24, 36, and 52 during the first year following the transplant procedure. Additional surveillance may be performed at any time when clinically indicated for the optimal management of the recipient. Information and specimens collected from each of these encounters will be entered in the data registry and specimen repository.
Detailed description
The collection of disposable lung allograft (transplant tissue samples), blood samples and information from medical records for storage, future analysis and research. Stored samples will be available to other researchers who have obtained separate review and approval from an ethics committee called an Institutional Review Board.
Immediately prior to the transplant surgery, the surgeon or pulmonologist will routinely examine the lungs via bronchoscopy during which subjects will be medicated for pain.
The samples that are obtained during this and post-surgery (clinically scheduled) bronchoscopies, including bronchial lavage, are either sent to pathology or are discarded if they do not qualify to go to pathology. For this research, the researchers are asking that the samples that do not qualify for pathology be placed into the repository instead of being thrown away.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- lung transplant recipients
Key inclusion criteria (1 listed)
- recipients of single and double lung transplantation (bilateral sequential, heart-lung, or living related donor grafts).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
data registry and lung tissue repository
Time frame: ongoing
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 20 Nov 2013.
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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.
David Nunley, MD principal investigator
Ohio State University
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 Lung 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 1 inclusion and 0 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 20 Nov 2013. 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?
data registry and lung tissue repository (time frame: ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2013.