Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06160310
Status:
RECRUITING
Last Update Posted:
2023-12-07
First Post:
2023-10-16
Brief Title:
Tuberous Sclerosis Complex and Lymphangioleiomyomatosis Pregnancy Registry TSC-LAM Registry
Sponsor:
David M Ritter
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Tuberous Sclerosis Complex and Lymphangioleiomyomatosis Pregnancy Registry
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mTOR pathway resulting in multiorgan disease Specifically patients are at risk for autism epilepsy intellectual disability renal cysts tuberous sclerosis associated neuropsychiatric disorder TAND lymphangioleiomyomatosis LAM and benign tumors throughout the body including subependymal giant cell astrocytomas SEGAs renal and liver angiomyolipomas AMLs and cardiac rhabdomyomas rhabdomyomas
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 healthmedication changes and other care For infants enrolled after birth clinical data will be collected and reviewed for up to 5 years of age
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 healthmedication changes and other care For infants enrolled after birth clinical data will be collected and reviewed for up to 5 years of age
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None