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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05323370
Other study ID # DR220020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 31, 2022
Est. completion date October 30, 2022

Study information

Verified date March 2023
Source University Hospital, Tours
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date October 30, 2022
Est. primary completion date October 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion criteria for patients with lymphangioleiomyomatosis - Age = 18 years - Female carrier of lymphangioleiomyomatosis according to ERS criteria Inclusion criteria for healthy female volunteers - Age = 18 years - Women with no history of lymphangioleiomyomatosis, pulmonary, renal or osteoporotic disease Inclusion criteria for tuberous sclerosis complex patients without lymphangioleiomyomatosis - 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) Non-inclusion criteria - Woman under judicial protection - Woman with a urinary tract infection within 15 days - Person who objected to the data processing

Study Design


Intervention

Other:
24h urine
Urine samples will be collected at home over 24 hours
urine sample
A urine sample of 20cc will be collected

Locations

Country Name City State
France University hospital Tours

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary urine cathepsin K proteins levels comparison of urine cathepsin K protein levels in the 3 groups inclusion visit
Primary urine cathepsin K activity comparison of urine cathepsin K activity in the 3 groups inclusion visit
Secondary urinary quantity of cystatin C comparison of urine cystacin C quantity in the 3 groups inclusion visit
Secondary urinary quantity C and N-telopeptides of type 1 collagen comparison in the 3 groups inclusion visit
Secondary serum level of chondroitin sulphates measurement in lymphangioleiomyomatosis patients inclusion visit
Secondary renal angiolipomas measurement of the size of renal angiomyolipomas in lymphangioleiomyomatosis patients inclusion visit
Secondary FEV1 measurement most recent FEV1 measurement as % of predicted value in lymphangioleiomyomatosis patients inclusion visit
Secondary VEGF-D measurement most recent measurement of VEGF-D blood levels in lymphangioleiomyomatosis patients inclusion visit
Secondary T-score measurement T-score measurement of the most recent bone densitometry in lymphangioleiomyomatosis patients inclusion visit
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