Cognitive DysfunctionsNCT01818193
Neurological Complications - Pulmonary Transplant
An observational study of Cognitive Dysfunctions, run by Hopital Foch at 1 site in France.
Trial summary
A monocentric prospective open study to evaluate the frequency and nature of cognitive complications in the 3rd month post pulmonary transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Dysfunctions
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to Mar 2014
- 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: patients enregistered in the waiting list for lung transplant
Who may be able to join
- Patients more than 18 years of age.
- Enregistered in lung transplant waiting list
- Have given their agreement to be enrolled in the study
Who cannot join
- Patients had a previous lung transplant
- patients with insufficient level of french language that may affect the comprehension and answering the psychometric test
Trial locations and contacts
1 site in 1 country.
About this study
A monocentric prospective open study to evaluate the frequency and nature of cognitive complications in the 3rd month post pulmonary transplant.
- Conditions
- Cognitive Dysfunctions
- Keywords
- Pulmonary transplant
- Medical subject headings
- Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Rey auditory verbal learning test
Measured: 3 months
Rey complex figure test
Measured: 3 months
Boston naming test of 30 figures
Measured: 3 months
Visual construction skills
Measured: 3 months
Grooved Pegboard test
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startJun 2012
- Primary completionDec 2013
- Study completionMar 2014
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionsStudies 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
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818193
- Sponsor's protocol ID
- 2011/60
- Status last verified
- Oct 2016
- First submitted
- 13 Mar 2013
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological Complications - Pulmonary Transplant
- ClinicalTrials.gov ID
- NCT01818193
- Acronym / sponsor ID
- 2011/60
- Conditions
- Cognitive Dysfunctions
- Keywords
- Pulmonary transplant
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 26 Mar 2013 (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.
A monocentric prospective open study to evaluate the frequency and nature of cognitive complications in the 3rd month post pulmonary transplant.
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
- patients enregistered in the waiting list for lung transplant
Key inclusion criteria (3 listed)
- Patients more than 18 years of age.
- Enregistered in lung transplant waiting list
- Have given their agreement to be enrolled in the study
Key exclusion criteria (2 listed)
- Patients had a previous lung transplant
- patients with insufficient level of french language that may affect the comprehension and answering the psychometric test
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
Rey auditory verbal learning test
Time frame: 3 months
Rey complex figure test
Time frame: 3 months
Boston naming test of 30 figures
Time frame: 3 months
Visual construction skills
Time frame: 3 months
Grooved Pegboard test
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Individual participant dataSharing planned: No
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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 Cognitive Dysfunctions, run by Hopital Foch 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 3 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: stopped early, as of the sponsor's last update on 31 Oct 2016. 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 was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
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?
Rey auditory verbal learning test (time frame: 3 months). The study lists 5 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 31 Oct 2016.