NCT01922635

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 12, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2022

Completed
Last Updated

May 18, 2023

Status Verified

May 1, 2023

Enrollment Period

8.5 years

First QC Date

August 12, 2013

Last Update Submit

May 16, 2023

Conditions

Primary Lymhedema

Keywords

Primary lymphedema quality of life, genetic research

Outcome Measures

Primary Outcomes (1)

  • Validation of the metrological properties of questionnaire of quality of life LYMPHOQOL

    3 Years

Study Arms (1)

1

OTHER
Other: Valadation of the metrological properties of questionnaire of quality of life

Interventions

Valadation of the metrological properties of questionnaire of quality of lifeOTHER
1

Eligibility Criteria

Age6 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Primary lymphedema, stage 2 or 3 ISL

You may not qualify if:

  • Primary lymphedema stage 1, secondary lymphedema, Minimum 6 years, maximum 25

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Montpellier

Montpellier, Herault, 34295, France

Location

Related Publications (1)

  • 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.

    PMID: 33625888DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2013

First Posted

August 14, 2013

Study Start

July 1, 2013

Primary Completion

January 13, 2022

Study Completion

January 13, 2022

Last Updated

May 18, 2023

Record last verified: 2023-05

Locations

FR(1)