Primary LymhedemaLYMPHOQOLNCT01922635
Validation of Metrological Properties of Lymphoqol
A study testing Valadation of the metrological properties of questionnaire of quality of life in people with Primary Lymhedema, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The constitutional lymphœdema is a rare disease with an annual incidence before the age of 20 years considered at 1,15/100 000. This chronic, incurable disease without hiring directly the prognosis for survival, alter the body image imposing a "visible" deformity and of which the treatment which aims at reducing and… Read more about this study
- Who is it for?
- Ages 6 to 25 years
- Conditions the study is for
- Primary Lymhedema
- What is being tested?
- Valadation of the metrological properties of questionnaire of quality of life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to 13 Jan 2022
- Phase
- Interventional
- 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 6 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Primary lymphedema, stage 2 or 3 ISL
Who cannot join
- Primary lymphedema stage 1, secondary lymphedema, Minimum 6 years, maximum 25
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Metrological Properties of Questionnaire of Quality of Life LYMPHOQOL
The constitutional lymphœdema is a rare disease with an annual incidence before the age of 20 years considered at 1,15/100 000. This chronic, incurable disease without hiring directly the prognosis for survival, alter the body image imposing a "visible" deformity and of which the treatment which aims at reducing and at stabilizing the physical deformation is binding and expensive. The lymphœdema is a crippling disease of the child. As such, it rings on the everyday life of the child and on the family environment. This question is all the more important, that all the studies show that the success of the treatment bases on the compliance in the concentration and in the care of hygiene. The parameters of the success of these treatments at the child are not known.
Read the detailed description
In the literature we find no specific information on the psychic and social repercussions of the lymphœdema for the child who is affected. If the psychic and social repercussions of the secondary lymphœdema in the breast cancer are well known, very few things are it on those of the primary lymphœdema. Some studies estimate globally the quality of life of the patients with a lymphœdema whatever is the origin and the etiologie. These studies of money groups suggest that the psychic difficulties and of therapeutic care are not identical. A single study approaches the specific question of the lymphœdema of the child by focusing on the real-life experience of expanding child of a primary lymphœdema.The construction and the validation of a tool measuring the quality of life of the children and the young adults affected by lymphœdema congenital appears as a starting point. A tool which would first of all allow to make the current situation for the regional level, and then can envisage national actions common. According to recent studies, the evolution of the lymphoedema is different according to the forms of initial clinical expression of the lymphoedema, we wish we can thus know during this study the impact of these various clinical forms on the quality of life of the patients. A genetic collection will be realized for that purpose (genetic research).
- Conditions
- Primary Lymhedema
- Being tested
- Valadation of the metrological properties of questionnaire of quality of life
- Keywords
- Primary lymphedema quality of life, genetic research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valadation of the metrological properties of questionnaire of quality of lifeOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Other: Valadation of the metrological properties of questionnaire of quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the metrological properties of questionnaire of quality of life LYMPHOQOL
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startJul 2013
- Primary completion13 Jan 2022
- Study completion13 Jan 2022
Why it stopped: Modification the study with a new questionnaire was not successful.
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 Primary LymhedemaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Marseille
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922635
- Sponsor's protocol ID
- 8967
- Acronym
- LYMPHOQOL
- Status last verified
- May 2023
- First submitted
- 12 Aug 2013
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Quere I, Stasi E, Mestre S, Roessler J, Roccatello D, Moffatt C. International Camps for Children with Lymphedema and Lymphatic Anomalies: When Education Links with Psychosocial Research. Lymphat Res Biol. 2021 Feb;19(1):36-40. doi: 10.1089/lrb.2020.0095.
PubMed 33625888
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Metrological Properties of Questionnaire of Quality of Life LYMPHOQOL
- ClinicalTrials.gov ID
- NCT01922635
- Acronym / sponsor ID
- LYMPHOQOL / 8967
- Conditions
- Primary Lymhedema
- Keywords
- Primary lymphedema quality of life, genetic research
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Modification the study with a new questionnaire was not successful.
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- University Hospital, Marseille
- Study start
- Jul 2013
- Primary completion
- 13 Jan 2022 (actual)
- Study completion
- 13 Jan 2022 (actual)
- First posted
- 14 Aug 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.
The constitutional lymphœdema is a rare disease with an annual incidence before the age of 20 years considered at 1,15/100 000. This chronic, incurable disease without hiring directly the prognosis for survival, alter the body image imposing a "visible" deformity and of which the treatment which aims at reducing and at stabilizing the physical deformation is binding and expensive. The lymphœdema is a crippling disease of the child. As such, it rings on the everyday life of the child and on the family environment. This question is all the more important, that all the studies show that the success of the treatment bases on the compliance in the concentration and in the care of hygiene. The parameters of the success of these treatments at the child are not known.
Detailed description
In the literature we find no specific information on the psychic and social repercussions of the lymphœdema for the child who is affected. If the psychic and social repercussions of the secondary lymphœdema in the breast cancer are well known, very few things are it on those of the primary lymphœdema. Some studies estimate globally the quality of life of the patients with a lymphœdema whatever is the origin and the etiologie. These studies of money groups suggest that the psychic difficulties and of therapeutic care are not identical. A single study approaches the specific question of the lymphœdema of the child by focusing on the real-life experience of expanding child of a primary lymphœdema.The construction and the validation of a tool measuring the quality of life of the children and the young adults affected by lymphœdema congenital appears as a starting point. A tool which would first of all allow to make the current situation for the regional level, and then can envisage national actions common. According to recent studies, the evolution of the lymphoedema is different according to the forms of initial clinical expression of the lymphoedema, we wish we can thus know during this study the impact of these various clinical forms on the quality of life of the patients. A genetic collection will be realized for that purpose (genetic research).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Valadation of the metrological properties of questionnaire of quality of life |
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Primary lymphedema, stage 2 or 3 ISL
Key exclusion criteria (1 listed)
- Primary lymphedema stage 1, secondary lymphedema, Minimum 6 years, maximum 25
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 |
|---|---|---|
| Valadation of the metrological properties of questionnaire of quality of life | Other | 1 |
Primary outcome
Validation of the metrological properties of questionnaire of quality of life LYMPHOQOL
Time frame: 3 Years
Results and safety
The study was stopped early (reason given: Modification the study with a new questionnaire was not successful.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Derived from this study: PubMed 33625888Quere I, Stasi E, Mestre S, Roessler J, Roccatello D, Moffatt C. International Camps for Children with Lymphedema and Lymphatic Anomalies: When Education Links with Psychosocial Research. Lymphat Res Biol. 2021 Feb;19(1):36-40. doi: 10.1089/lrb.2020.0095.
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?
A study testing Valadation of the metrological properties of questionnaire of quality of life in people with Primary Lymhedema, run by University Hospital, Montpellier 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 1 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: stopped early, as of the sponsor's last update on 18 May 2023. 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: Modification the study with a new questionnaire was not successful.). 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?
Validation of the metrological properties of questionnaire of quality of life LYMPHOQOL (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 NCT01922635, 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 18 May 2023.