LymphangioleiomyomatosisLAM-CAKNCT05323370
Lymphangioleiomyomatosis, a Study on Cathepsin K
An observational study of Lymphangioleiomyomatosis and Tuberous Sclerosis Complex, run by University Hospital, Tours at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lymphangioleiomyomatosis, Tuberous Sclerosis Complex
- What is being tested?
- 24h urine and urine sample
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2022to 30 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult female patients with lymphangioleiomyomatosis or with tuberous sclerosis complexwithout AML or healthy volunteers
Who may be able to join
- 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
Show all 9Show fewer
- Woman under judicial protection
- Woman with a urinary tract infection within 15 days
- Person who objected to the data processing
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of New Potential Biomarkers of Lymphangioleiomyomatosis: Determination of Cathepsin K, Cystatin C, Collagen Telopeptides and Chondroitin Sulfates
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.
- Being tested
- 24h urine, urine sample
- Keywords
- urine
- Medical subject headings
- Lymphangioleiomyomatosis, Tuberous Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24h urineOther
Urine samples will be collected at home over 24 hours
urine sampleOther
A urine sample of 20cc will be collected
| Study group | Role | What they receive |
|---|---|---|
| Patientes with lymphangioleiomyomatosis | no intervention administered. Recruitment in pneumology department Receives: Other: 24h urine; Other: urine sample | |
| Patientes with tuberous sclerosis complex without Lymphangioleiomyomatosis | no intervention administered. Recruitment in neurology department Receives: Other: 24h urine; Other: urine sample | |
| Healthy women volunteers | no intervention administered. Recruitment in clinical investigation centre Receives: Other: 24h urine; Other: urine sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
urine cathepsin K proteins levels
comparison of urine cathepsin K protein levels in the 3 groups
Measured: inclusion visit
urine cathepsin K activity
comparison of urine cathepsin K activity in the 3 groups
Measured: inclusion visit
Secondary outcomes (7)
urinary quantity of cystatin C
comparison of urine cystacin C quantity in the 3 groups
Measured: inclusion visit
urinary quantity C and N-telopeptides of type 1 collagen
comparison in the 3 groups
Measured: inclusion visit
serum level of chondroitin sulphates
measurement in lymphangioleiomyomatosis patients
Measured: inclusion visit
renal angiolipomas
measurement of the size of renal angiomyolipomas in lymphangioleiomyomatosis patients
Measured: inclusion visit
FEV1 measurement
most recent FEV1 measurement as % of predicted value in lymphangioleiomyomatosis patients
Measured: inclusion visit
VEGF-D measurement
most recent measurement of VEGF-D blood levels in lymphangioleiomyomatosis patients
Measured: inclusion visit
T-score measurement
T-score measurement of the most recent bone densitometry in lymphangioleiomyomatosis patients
Measured: inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start31 May 2022
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphangioleiomyomatosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain MARCHAND-ADAM, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323370
- Sponsor's protocol ID
- DR220020
- Acronym
- LAM-CAK
- Status last verified
- Mar 2023
- First submitted
- 4 Apr 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of New Potential Biomarkers of Lymphangioleiomyomatosis: Determination of Cathepsin K, Cystatin C, Collagen Telopeptides and Chondroitin Sulfates
- ClinicalTrials.gov ID
- NCT05323370
- Acronym / sponsor ID
- LAM-CAK / DR220020
- Keywords
- urine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patientes with lymphangioleiomyomatosis | – | Other: 24h urine, Other: urine sampleno intervention administered. Recruitment in pneumology department |
| Patientes with tuberous sclerosis complex without Lymphangioleiomyomatosis | – | Other: 24h urine, Other: urine sampleno intervention administered. Recruitment in neurology department |
| Healthy women volunteers | – | Other: 24h urine, Other: urine sampleno intervention administered. Recruitment in clinical investigation centre |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult female patients with lymphangioleiomyomatosis or with tuberous sclerosis complexwithout AML or healthy volunteers
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24h urineUrine samples will be collected at home over 24 hours | Other | Healthy women volunteers, Patientes with lymphangioleiomyomatosis, Patientes with tuberous sclerosis complex without Lymphangioleiomyomatosis |
| urine sampleA urine sample of 20cc will be collected | Other | Healthy women volunteers, Patientes with lymphangioleiomyomatosis, Patientes with tuberous sclerosis complex without Lymphangioleiomyomatosis |
Primary outcome
urine cathepsin K proteins levels
Time frame: inclusion visit
comparison of urine cathepsin K protein levels in the 3 groups
urine cathepsin K activity
Time frame: inclusion visit
comparison of urine cathepsin K activity in the 3 groups
7 secondary outcomes
urinary quantity of cystatin C
Time frame: inclusion visit
urinary quantity C and N-telopeptides of type 1 collagen
Time frame: inclusion visit
serum level of chondroitin sulphates
Time frame: inclusion visit
renal angiolipomas
Time frame: inclusion visit
FEV1 measurement
Time frame: inclusion visit
VEGF-D measurement
Time frame: inclusion visit
T-score measurement
Time frame: inclusion visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: Undecided
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TSC Biosample Repository and Natural History Database
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvain MARCHAND-ADAM principal investigator
University Hospital, Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphangioleiomyomatosis and Tuberous Sclerosis Complex, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urine cathepsin K proteins levels (time frame: inclusion visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.