Status:
RECRUITING
Tuberous Sclerosis Complex and Lymphangioleiomyomatosis Pregnancy Registry (TSC-LAM Registry)
Lead Sponsor:
David M. Ritter
Conditions:
Tuberous Sclerosis Complex
Lymphangioleiomyomatosis
Eligibility:
FEMALE
Brief Summary
This study is an observational registry designed to gather information about Tuberous Sclerosis Complex (TSC) and Lymphangioleiomyomatosis (LAM) in pregnant women and their child.
Detailed Description
Tuberous sclerosis complex (TSC) is caused by mutations in tuberous sclerosis complex 1 (TSC 1) and tuberous sclerosis complex 2 (TSC 2) leading to overactivation of the mammilian target of rapamycin ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06160310
Start Date
July 1 2023
End Date
July 1 2029
Last Update
January 15 2025
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229