Lymphangioleiomyomatosis, a Study on Cathepsin K

Tuberous Sclerosis Complex Clinical Trial

— LAM-CAK  

Official title:

Study of New Potential Biomarkers of Lymphangioleiomyomatosis: Determination of Cathepsin K, Cystatin C, Collagen Telopeptides and Chondroitin Sulfates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05323370
• Other study ID #: DR220020
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Lymphangioleiomyomatosis
• Tuberous Sclerosis
• Tuberous Sclerosis Complex

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