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Tuberous Sclerosis Complex and Lymphangioleiomyomatosis Pregnancy Registry (TSC-LAM Registry)

Tuberous Sclerosis Complex and Lymphangioleiomyomatosis Pregnancy Registry

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study collects information about tuberous sclerosis complex (TSC) and lymphangioleiomyomatosis (LAM) during pregnancy. It is for pregnant women with these conditions or certain possible signs or risks of TSC in themselves or their unborn baby, and babies born to enrolled women.

This study is an observational registry designed to gather information about Tuberous Sclerosis Complex (TSC) and Lymphangioleiomyomatosis (LAM) in pregnant women and their child.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Pregnant women diagnosed with TSC through medical signs or genetic testing, using the 2021 diagnosis guidelines.
  • Pregnant women diagnosed with LAM.
  • Pregnant women with a change in the TSC1 or TSC2 gene whose meaning is not yet known.
  • Pregnant women whose unborn baby has a 50% chance of TSC, as judged by a study doctor.
  • Pregnant women whose unborn baby may have TSC because of heart tumors called rhabdomyomas, brain growths called tubers, or a brain tumor called a congenital subependymal giant cell astrocytoma.
  • Babies born to someone enrolled in the study.

Who can't join

  • Pregnant women without TSC who used embryo testing for TSC before pregnancy, unless a study doctor judges that the unborn baby has a 50% chance of TSC.
  • Babies diagnosed with TSC whose birth mother was not enrolled in the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

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