NCT05323370

Brief Summary

This is a physiopathological case-control, non-interventional, monocentric study of adult patients with lymphangioleiomyomatosis. The controls are patients followed in neurology at the CHU of Tours for a tuberous sclerosis complex without lymphangioleiomyomatosis, the healthy volunteers are women with neither pulmonary nor renal pathology and recruited at the clinical investigation centre of the CHU of Tours.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 4, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 31, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

April 4, 2022

Last Update Submit

March 28, 2023

Conditions

LymphangioleiomyomatosisTuberous Sclerosis Complex

Keywords

urine

Outcome Measures

Primary Outcomes (2)

  • urine cathepsin K proteins levels

    comparison of urine cathepsin K protein levels in the 3 groups

    inclusion visit

  • urine cathepsin K activity

    comparison of urine cathepsin K activity in the 3 groups

    inclusion visit

Secondary Outcomes (7)

  • urinary quantity of cystatin C

    inclusion visit

  • urinary quantity C and N-telopeptides of type 1 collagen

    inclusion visit

  • serum level of chondroitin sulphates

    inclusion visit

  • renal angiolipomas

    inclusion visit

  • FEV1 measurement

    inclusion visit

  • +2 more secondary outcomes

Study Arms (3)

Patientes with lymphangioleiomyomatosis

no intervention administered. Recruitment in pneumology department

Other: 24h urineOther: urine sample

Patientes with tuberous sclerosis complex without Lymphangioleiomyomatosis

no intervention administered. Recruitment in neurology department

Other: 24h urineOther: urine sample

Healthy women volunteers

no intervention administered. Recruitment in clinical investigation centre

Other: 24h urineOther: urine sample

Interventions

24h urineOTHER

Urine samples will be collected at home over 24 hours

Healthy women volunteersPatientes with lymphangioleiomyomatosisPatientes with tuberous sclerosis complex without Lymphangioleiomyomatosis
urine sampleOTHER

A urine sample of 20cc will be collected

Healthy women volunteersPatientes with lymphangioleiomyomatosisPatientes with tuberous sclerosis complex without Lymphangioleiomyomatosis

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult female patients with lymphangioleiomyomatosis or with tuberous sclerosis complexwithout AML or healthy volunteers

You may qualify if:

  • Age ≥ 18 years
  • Female carrier of lymphangioleiomyomatosis according to ERS criteria
  • Age ≥ 18 years
  • Women with no history of lymphangioleiomyomatosis, pulmonary, renal or osteoporotic disease
  • Age ≥ 18 years
  • Woman followed for tuberous sclerosis complex for whom a chest CT scan less than 3 years old does not objectify a pulmonary cyst. (= without lymphangioleiomyomatosis)
  • Woman under judicial protection
  • Woman with a urinary tract infection within 15 days
  • Person who objected to the data processing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital

Tours, 37044, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine

MeSH Terms

Conditions

LymphangioleiomyomatosisTuberous Sclerosis

Interventions

Urination

Condition Hierarchy (Ancestors)

LymphangiomyomaNeoplasm, Lymphatic TissueNeoplasms by Histologic TypeNeoplasmsPerivascular Epithelioid Cell NeoplasmsNeoplasms, Connective and Soft TissueLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHamartomaNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryMalformations of Cortical Development, Group IMalformations of Cortical DevelopmentNervous System MalformationsNervous System DiseasesNeurocutaneous SyndromesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Sylvain MARCHAND-ADAM

    University Hospital, Tours

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2022

First Posted

April 12, 2022

Study Start

May 31, 2022

Primary Completion

October 30, 2022

Study Completion

October 30, 2022

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations

FR(1)