Tuberous Sclerosis Complex and Lymphangioleiomyomatosis Pregnancy Registry (TSC-LAM Registry)
NCT ID: NCT06160310
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
300 participants
OBSERVATIONAL
2023-07-01
2029-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
TSC Biosample Repository and Natural History Database
NCT05676099
Genetics of Neural Tube Defects
NCT01253746
The Genotype and Phenotype of Lymphangioleiomyomatosis
NCT06405997
Comprehensive HHT Outcomes Registry of the United States (CHORUS)
NCT06259292
Identification of Genetic and Cellular Markers Associated With Vascular Endothelial Modifications in Cutaneous Arteriovenous Malformations
NCT01774916
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Sporadic LAM occurs mostly in women and many patients with LAM have TSC gene mutations.
The purpose of this study is to gather information to help clinicians develop evidence-based guidance for the care of TSC and LAM patients during pregnancy and to provide screening recommendations for fetal TSC.
Participants will be asked to complete monthly online surveys screening for changes in the pregnancy, maternal health/medication changes, and other care. For infants enrolled after birth, clinical data will be collected and reviewed for up to 5 years of age.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* A pregnant woman with a diagnosis of LAM
* A pregnant woman with a variant of uncertain significance in TSC 1 or TSC 2
* A pregnant woman who is pregnant and the fetus has a 50% chance of TSC as deemed by the PI or Sub-Is
* A pregnant woman whose fetus is found to have concern for TSC secondary to rhabdomyomas, tubers, or congenital subependymal giant cell astrocytoma.
* An infant born to an enrolled individual.
* Infants diagnosed with TSC whose birth mother was not enrolled.
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
David M. Ritter
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
David M. Ritter
Sponsor/Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David M Ritter, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-0973
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.