Lung TransplantationNCT04667806
Health Related Quality of Life in Lung Transplantation in Strasbourg
An observational study of Lung Transplantation, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The aim of this study is to study the quality of life in lung transplant patients. The cohort includes all of the surviving and transplanted patients at the New Civil Hospital in Strasbourg between 2008 and 2018. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplantation
- What is being tested?
- Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2021to Apr 2022
- 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: Transplants survivors in Strasbourg hospital between 2008 et 2018
Who may be able to join
- Transplants survivors in Strasbourg hospital between 2008 et 2018
- Patient able to answer a questionnaire in french
Who cannot join
- Pregnancy
- Vulnerability
- Safeguard of justice, curatorship or tutorship
- Emergency situation
- Difficilty in understanding
Trial locations and contacts
1 site in 1 country.
France1 site
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
Lina JAZERLI, +33 3 69 55 16 22, lina.jazaerli@chru-strasbourg.fr
Lina JAZERLI
About this study
Official title: Study of the Quality of Life in Surviving Lung Transplant Patients Between 2008 and 2018 by SF36 and St Georges's Questionnaires
The aim of this study is to study the quality of life in lung transplant patients. The cohort includes all of the surviving and transplanted patients at the New Civil Hospital in Strasbourg between 2008 and 2018. The main objective is to assess the quality of life of this cohort by two questionnaires which are the SF36 (generic score) and the saint Georges's questionnaire (specific score).
The secondary objectives are the measurement of survival after lung transplantation, the comparison of the quality of life of these patients with that of the general population by the SF36 questionnaire, the search for perioperative factors influencing the quality of life and finally the search for an association between quality of life and socio-professional life.
- Conditions
- Lung Transplantation
- Being tested
- Questionnaires
- Keywords
- Health related quality of life, Lung transplantation, SF36, St Georges's Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Use questionnaires ( SF36 questionnaire (generic score) and St Georges's questionnaire (specific score))
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life
Score obtained by a questionnaire : SF36
Measured: 12 month
Health related quality of life
Score obtained by a questionnaire : St Georges
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study startApr 2021 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionApr 2022 (estimated)
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.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667806
- Sponsor's protocol ID
- 7952
- Status last verified
- Mar 2021
- First submitted
- 24 Nov 2020
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Quality of Life in Surviving Lung Transplant Patients Between 2008 and 2018 by SF36 and St Georges's Questionnaires
- ClinicalTrials.gov ID
- NCT04667806
- Acronym / sponsor ID
- 7952
- Conditions
- Lung Transplantation
- Keywords
- Health related quality of life, Lung transplantation, SF36, St Georges's Respiratory
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 16 Dec 2020 (actual)
- 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.
The aim of this study is to study the quality of life in lung transplant patients. The cohort includes all of the surviving and transplanted patients at the New Civil Hospital in Strasbourg between 2008 and 2018. The main objective is to assess the quality of life of this cohort by two questionnaires which are the SF36 (generic score) and the saint Georges's questionnaire (specific score).
The secondary objectives are the measurement of survival after lung transplantation, the comparison of the quality of life of these patients with that of the general population by the SF36 questionnaire, the search for perioperative factors influencing the quality of life and finally the search for an association between quality of life and socio-professional life.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Transplants survivors in Strasbourg hospital between 2008 et 2018
Key inclusion criteria (2 listed)
- Transplants survivors in Strasbourg hospital between 2008 et 2018
- Patient able to answer a questionnaire in french
Key exclusion criteria (5 listed)
- Pregnancy
- Vulnerability
- Safeguard of justice, curatorship or tutorship
- Emergency situation
- Difficilty in understanding
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 |
|---|---|---|
| QuestionnairesUse questionnaires ( SF36 questionnaire (generic score) and St Georges's questionnaire (specific score)) | Behavioural | – |
Primary outcome
Health related quality of life
Time frame: 12 month
Score obtained by a questionnaire : SF36
Health related quality of life
Time frame: 12 month
Score obtained by a questionnaire : St Georges
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- 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.
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 University Hospital, Strasbourg, France 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 5 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: status not confirmed, as of the sponsor's last update on 30 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lina JAZAERLI (+ 33 3 69 55 16 22, lina.jazaerli@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life (time frame: 12 month). The study lists 2 primary outcomes in all. 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 30 Mar 2021.