RECRUITING

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

Conditions

Tuberous Sclerosis Complex Lymphangioleiomyomatosis TSC LAM

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Tuberous Sclerosis Complex and Lymphangioleiomyomatosis Pregnancy Registry

Quick Facts

Study Start:2023-07-01

Study Completion:2029-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06160310

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Molly S Griffith, BA

CONTACT

513-636-9669

molly.griffith@cchmc.org

Adrienne Victory

CONTACT

513-636-8016

adrienne.victory@cchmc.org

Principal Investigator

David M Ritter, MD, PhD

PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Study Locations (Sites)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Collaborators and Investigators

Sponsor: David M. Ritter

David M Ritter, MD, PhD, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-01

Study Completion Date2029-07-01

Study Record Updates

Study Start Date2023-07-01

Study Completion Date2029-07-01

Terms related to this study

Keywords Provided by Researchers

Tuberous Sclerosis Complex
TSC
Lymphangioleiomyomatosis
LAM

Additional Relevant MeSH Terms

Tuberous Sclerosis Complex
Lymphangioleiomyomatosis