NCT01484236

Brief Summary

RE-LAM-CE is a registry of lymphangioleiomyomatosis cases in France. its aim is to determine the incidence and prevalence of lymphangioleiomyomatosis in France, including demographic information and information concerning the timing and modalities of diagnosis. Based on the registry, we will set up a prospective cohort of patients. The database will include detailed medical information, particularly regarding progression of the respiratory function.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Jan 2012Dec 2026

First Submitted

Initial submission to the registry

November 30, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
13.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

13.9 years

First QC Date

November 30, 2011

Last Update Submit

March 11, 2025

Conditions

Lymphangioleiomyomatosis

Keywords

Lymphangioleiomyomatosis

Outcome Measures

Primary Outcomes (1)

  • Number of cases

    Determine incidence and prevalence of lymphangioleiomyomatosis.

    4 years

Secondary Outcomes (3)

  • localisation of cases

    4 years

  • Progression-free survival

    4 years

  • Progression-free survival

    4 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with lymphangioleiomyomatosis

You may qualify if:

  • Patients with sporadic lymphangioleiomyomatosis or associated with Tuberous sclerosis.
  • patients diagnosed or hospitalized or seen in consultation since 01/01/2008

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Louis Pradel

Lyon, 69677, France

RECRUITING

MeSH Terms

Conditions

Lymphangioleiomyomatosis

Condition Hierarchy (Ancestors)

LymphangiomyomaNeoplasm, Lymphatic TissueNeoplasms by Histologic TypeNeoplasmsPerivascular Epithelioid Cell NeoplasmsNeoplasms, Connective and Soft TissueLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Vincent Cottin, MD

    Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires, HCL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Cottin, MD

CONTACT

33-427-857-700

Raphaële Guelminger, CRA

CONTACT

33-472-357-074

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor V. Cottin

Study Record Dates

First Submitted

November 30, 2011

First Posted

December 2, 2011

Study Start

January 1, 2012

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)