Lymphangioleiomyomatosis, a Study on Cathepsin K

NCT ID: NCT05323370

Last Updated: 2023-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-31

Study Completion Date

2022-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphangioleiomyomatosis Tuberous Sclerosis Complex

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patientes with lymphangioleiomyomatosis

no intervention administered. Recruitment in pneumology department

24h urine

Intervention Type OTHER

Urine samples will be collected at home over 24 hours

urine sample

Intervention Type OTHER

A urine sample of 20cc will be collected

Patientes with tuberous sclerosis complex without Lymphangioleiomyomatosis

no intervention administered. Recruitment in neurology department

24h urine

Intervention Type OTHER

Urine samples will be collected at home over 24 hours

urine sample

Intervention Type OTHER

A urine sample of 20cc will be collected

Healthy women volunteers

no intervention administered. Recruitment in clinical investigation centre

24h urine

Intervention Type OTHER

Urine samples will be collected at home over 24 hours

urine sample

Intervention Type OTHER

A urine sample of 20cc will be collected

Interventions

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24h urine

Urine samples will be collected at home over 24 hours

Intervention Type OTHER

urine sample

A urine sample of 20cc will be collected

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sylvain MARCHAND-ADAM

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Tours

Locations

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University hospital

Tours, , France

Site Status

Countries

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France

Other Identifiers

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DR220020

Identifier Type: -

Identifier Source: org_study_id

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