Clinical trial · Observational
Tuberous Sclerosis Complex and Lymphangioleiomyomatosis Pregnancy Registry (TSC-LAM Registry)
Tuberous Sclerosis Complex and Lymphangioleiomyomatosis Pregnancy Registry
NCT06160310CI-TRIAL-00101515recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is an observational registry designed to gather information about Tuberous Sclerosis Complex (TSC) and Lymphangioleiomyomatosis (LAM) in pregnant women and their child.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphangioleiomyomatosis | Lymphangioleiomyomatosis | ONTOLOGY_EXACT | 0.98 |
| Tuberous Sclerosis Complex | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (7)
- measure
- Safety of mTOR inhibitor in Pregnancy -- mTOR inhibitor adherence
- timeFrame
- During pregnancy (up to 40 weeks) through 6 months post-delivery
- description
- Assess number of days participant takes mTOR inhibitor in relation to number of days participant was supposed to take mTOR inhibitor.
- measure
- Safety of mTOR inhibitor in Pregnancy -- mTOR inhibitor dosing
- timeFrame
- During pregnancy (up to 40 weeks) through 6 months post-delivery
- description
- Review mTOR inhibitor dosing for each participant.
- measure
- Safety of mTOR inhibitor in Pregnancy -- side effects
- timeFrame
- During pregnancy (up to 40 weeks) through 6 months post-delivery
- description
- Monitor side effects of mTOR inhibitor experienced by participant.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.