Pulmonary ComplicationsALLOPULMNCT01219972
Pulmonary Complications of Allografts
An observational study of Pulmonary Complications, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This is a prognostic study of the late lung complications arising at the patient's having received an allograft of hematopoetic stem cells. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Complications
- How many people
- 245 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2006to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent a allogeneic blood stem cell transplantation, alive at 100 days post-transplantation
Who may be able to join
- Allogeneic Blood stem cell transplantation
- Alive at day 100 post-transplant
Who cannot join
- Non informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Cohort Study of Late Pulmonary Complications in Patients Who Received Allogeneic Hematopoietic Stem Cells Transplantation: Estimation of Incidence and Identification of Distinct Nosologic Entities
This is a prognostic study of the late lung complications arising at the patient's having received an allograft of hematopoetic stem cells.
Read the detailed description
- Objectives To estimate the incidence of late (at least occurring 100 days after transplantation) pulmonary complications following allogeneic blood stem cells transplantation
- Study Design Prospective Cohort Study All follow-up data were actualiized in September, 2016.
- Sample Size 200 transplanted patients
- Main Endpoint Non infectious pulmonary complications within the first 3 years
- Conditions
- Pulmonary Complications
- Keywords
- Bone marrow transplant, Pulmonary complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Allografted patients | * All consecutive patients who underwent an allogeneic blood stem cells transplantation performed at saint Louis hospital during the study recruitment period * if alive at 100 days post-transplant * and who gave informed consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non infectious pulmonary complication
Measured: 3 years
Secondary outcomes (3)
Survival after non infectious pulmonary complication
Measured: 3 years and 10 years
Overall survival
Measured: 3 years and 10 years
Long term time course of Pulmonary Function Tests (PFTs)
Measured: 3 years and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startJan 2006
- Primary completionFeb 2009
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary ComplicationsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Bergeron - Laffaurie,, PhDMD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219972
- Sponsor's protocol ID
- CRC 04118
- Acronym
- ALLOPULM
- Status last verified
- Dec 2016
- First submitted
- 11 Oct 2010
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Bergeron A, Chevret S, Peffault de Latour R, Chagnon K, de Margerie-Mellon C, Riviere F, Robin M, Mani J, Lorillon G, Socie G, Tazi A. Noninfectious lung complications after allogeneic haematopoietic stem cell transplantation. Eur Respir J. 2018 May 3;51(5):1702617. doi: 10.1183/13993003.02617-2017. Print 2018 May.
PubMed 29650555
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Late Pulmonary Complications in Patients Who Received Allogeneic Hematopoietic Stem Cells Transplantation: Estimation of Incidence and Identification of Distinct Nosologic Entities
- ClinicalTrials.gov ID
- NCT01219972
- Acronym / sponsor ID
- ALLOPULM / CRC 04118
- Conditions
- Pulmonary Complications
- Keywords
- Bone marrow transplant, Pulmonary complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Oct 2010 (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 is a prognostic study of the late lung complications arising at the patient's having received an allograft of hematopoetic stem cells.
Detailed description
- Objectives To estimate the incidence of late (at least occurring 100 days after transplantation) pulmonary complications following allogeneic blood stem cells transplantation
- Study Design Prospective Cohort Study All follow-up data were actualiized in September, 2016.
- Sample Size 200 transplanted patients
- Main Endpoint Non infectious pulmonary complications within the first 3 years
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allografted patients | – | –* All consecutive patients who underwent an allogeneic blood stem cells transplantation performed at saint Louis hospital during the study recruitment period * if alive at 100 days post-transplant * and who gave informed consent |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent a allogeneic blood stem cell transplantation, alive at 100 days post-transplantation
Key inclusion criteria (2 listed)
- Allogeneic Blood stem cell transplantation
- Alive at day 100 post-transplant
Key exclusion criteria (1 listed)
- Non informed consent
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
Non infectious pulmonary complication
Time frame: 3 years
3 secondary outcomes
Survival after non infectious pulmonary complication
Time frame: 3 years and 10 years
Overall survival
Time frame: 3 years and 10 years
Long term time course of Pulmonary Function Tests (PFTs)
Time frame: 3 years and 10 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 4 Jan 2017.
- Derived from this study: PubMed 29650555Bergeron A, Chevret S, Peffault de Latour R, Chagnon K, de Margerie-Mellon C, Riviere F, Robin M, Mani J, Lorillon G, Socie G, Tazi A. Noninfectious lung complications after allogeneic haematopoietic stem cell transplantation. Eur Respir J. 2018 May 3;51(5):1702617. doi: 10.1183/13993003.02617-2017. Print 2018 May.
- Individual participant dataSharing planned: Undecided
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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.
Anne Bergeron - Laffaurie,, PhDMD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Pulmonary Complications, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 1 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 4 Jan 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 France. 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?
Non infectious pulmonary complication (time frame: 3 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 NCT01219972, which also lists 1 linked publication.
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 4 Jan 2017.