Amyotrophic Lateral SclerosisNCT00337402
Effects of Gastrostomy on Amyotrophic Lateral Sclerosis
An observational study of Amyotrophic Lateral Sclerosis, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Results about effects of symptomatic treatment on QoL appears conflicting in ALS patients. Moreover no clear effects of gastrotomy have be shown on survival. Prospective study on effect of tube feeding, QoL and survival is performed in 17 teaching hospitals in France (observational study) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- How many people
- 380 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2002to Jun 2005
- 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
Who may be able to join
- patients > 18 years-old
- ALS certain or probable
- vital capacity (respiratory) > 70 %
- under riluzole
Who cannot join
- ALS in family
- other conditions affected survival and QoL
- cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Gastrostomy on Quality of Life and Survival in Patients With Amyotrophic Lateral Sclerosis
Results about effects of symptomatic treatment on QoL appears conflicting in ALS patients. Moreover no clear effects of gastrotomy have be shown on survival. Prospective study on effect of tube feeding, QoL and survival is performed in 17 teaching hospitals in France (observational study)
Read the detailed description
Following data have been recorded each three months: QoL (MOS-SF 36 and ALSAQ), bodily mass index, testing and ALS-FRS scale, functional respiratory measures, impedance analysis, and the time for tube feeding procedure, the conditions of the acceptance and side-effects of gastrotomy
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Gastrostomy, Quality of life
- Medical subject headings
- Amyotrophic Lateral Sclerosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2006 (estimated)
- Study startJan 2002
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 380 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Angers, University Hospital, Bordeaux, University Hospital, Caen, University Hospital, Grenoble, University Hospital, Lille, University Hospital, Limoges, Neurological department of Lyon University Hospital, University Hospital, Marseille, University Hospital, Montpellier, Central Hospital, Nancy, France, Centre Hospitalier Universitaire de Nice, University Hospital, Paris, University Hospital, Strasbourg, University Hospital, Toulouse, University Hospital, Tours
- Investigators
- Pierre Clavelou, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337402
- Sponsor's protocol ID
- CHU63-0001
- Status last verified
- Jun 2006
- First submitted
- 15 Jun 2006
- Last updated
- 22 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Gastrostomy on Quality of Life and Survival in Patients With Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT00337402
- Acronym / sponsor ID
- CHU63-0001
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Gastrostomy, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 380 participants
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- University Hospital, Angers, University Hospital, Bordeaux, University Hospital, Caen, University Hospital, Grenoble, University Hospital, Lille, University Hospital, Limoges, Neurological department of Lyon University Hospital, University Hospital, Marseille, University Hospital, Montpellier, Central Hospital, Nancy, France, Centre Hospitalier Universitaire de Nice, University Hospital, Paris, University Hospital, Strasbourg, University Hospital, Toulouse, University Hospital, Tours
- Study start
- Jan 2002
- Study completion
- Jun 2005
- First posted
- 16 Jun 2006 (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.
Results about effects of symptomatic treatment on QoL appears conflicting in ALS patients. Moreover no clear effects of gastrotomy have be shown on survival. Prospective study on effect of tube feeding, QoL and survival is performed in 17 teaching hospitals in France (observational study)
Detailed description
Following data have been recorded each three months: QoL (MOS-SF 36 and ALSAQ), bodily mass index, testing and ALS-FRS scale, functional respiratory measures, impedance analysis, and the time for tube feeding procedure, the conditions of the acceptance and side-effects of gastrotomy
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients > 18 years-old
- ALS certain or probable
- vital capacity (respiratory) > 70 %
- under riluzole
Key exclusion criteria (3 listed)
- ALS in family
- other conditions affected survival and QoL
- cognitive impairment
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
Not reported in the source record.
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 22 Nov 2006.
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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.
Pierre Clavelou principal investigator
University Hospital, Clermont-Ferrand
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 Amyotrophic Lateral Sclerosis, run by University Hospital, Clermont-Ferrand 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 4 inclusion and 3 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 22 Nov 2006. 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.
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 22 Nov 2006.