Tuberous Sclerosis Complex and Lymphangioleiomyomatosis Pregnancy Registry (TSC-LAM Registry)
Recruiting · NCT06160310 · Observational (researchers observe without assigning treatment) · Lead sponsor: David M. Ritter
View the official record on ClinicalTrials.gov →What this trial is about
This study is an observational registry designed to gather information about Tuberous Sclerosis Complex (TSC) and Lymphangioleiomyomatosis (LAM) in pregnant women and their child.
Who can take part
Age range
No age limits stated
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- A pregnant woman with a clinical or genetic diagnosis of TSC as determined by the 2021 Consensus Guidelines (1)
- 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.
Exclusion criteria
- A pregnant woman without TSC who has used preimplantation genetic testing for TSC unless qualifies under inclusion criteria #4.
- Infants diagnosed with TSC whose birth mother was not enrolled.
Where it is running
1 location listed across 1 US state.
- Cincinnati Children's Hospital Medical Center - Cincinnati, Ohio, United States