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NCT Number: NCT05323370

Lymphangioleiomyomatosis, a Study on Cathepsin K

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.

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Key information

Conditions

Lymphangioleiomyomatosis Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hamartoma Hemic and Lymphatic Diseases Heredodegenerative Disorders, Nervous System Immune System Diseases Immunoproliferative Disorders Lymphangiomyoma Lymphatic Diseases Lymphoproliferative Disorders Malformations of Cortical Development Malformations of Cortical Development, Group I Neoplasm, Lymphatic Tissue Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Nervous System Diseases Nervous System Malformations Neurocutaneous Syndromes Neurodegenerative Diseases Perivascular Epithelioid Cell Neoplasms Tuberous Sclerosis Tuberous Sclerosis Complex

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University hospital

Tours, 37044, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

24h urine

Other

Urine samples will be collected at home over 24 hours

Urine sample

Other

A urine sample of 20cc will be collected

Primary outcomes

  1. urine cathepsin K proteins levels

    Time frame: inclusion visit

    comparison of urine cathepsin K protein levels in the 3 groups

  2. urine cathepsin K activity

    Time frame: inclusion visit

    comparison of urine cathepsin K activity in the 3 groups

Secondary outcomes

  1. urinary quantity of cystatin C

    Time frame: inclusion visit

    comparison of urine cystacin C quantity in the 3 groups

  2. urinary quantity C and N-telopeptides of type 1 collagen

    Time frame: inclusion visit

    comparison in the 3 groups

  3. serum level of chondroitin sulphates

    Time frame: inclusion visit

    measurement in lymphangioleiomyomatosis patients

  4. renal angiolipomas

    Time frame: inclusion visit

    measurement of the size of renal angiomyolipomas in lymphangioleiomyomatosis patients

  5. FEV1 measurement

    Time frame: inclusion visit

    most recent FEV1 measurement as % of predicted value in lymphangioleiomyomatosis patients

  6. VEGF-D measurement

    Time frame: inclusion visit

    most recent measurement of VEGF-D blood levels in lymphangioleiomyomatosis patients

  7. T-score measurement

    Time frame: inclusion visit

    T-score measurement of the most recent bone densitometry in lymphangioleiomyomatosis patients

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

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

Acronym: LAM-CAK

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 12, 2022
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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