TSC Biosample Repository and Natural History Database

RecruitingOBSERVATIONAL
Enrollment

5,000

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

December 31, 2050

Study Completion Date

December 31, 2050

Conditions
Tuberous SclerosisLymphangioleiomyomatosis
Interventions
PROCEDURE

Phlebotomy

Participants may elect to submit a blood sample to the Biosample Repository.

PROCEDURE

Buccal (cheek) swab

Participants may elect to submit a buccal swab sample to the Biosample Repository.

GENETIC

Genetic Testing

Biosamples may be processed and analyzed for genetic variants using whole genome sequencing (WGS) or other sequencing methods. Participants whose samples are processed in this manner may be contacted and provided the option to receive TSC1 or TSC2 genetic variant results by opting in using Consent to Return of Genetic Results Form. Participants will be offered a one-time genetic counseling session to review their results, free of charge. CLIA-certified, TSC1 or TSC2 genetic variant results will be returned to participants who opt in to receive such results. Additionally, negative results and results not able to be clinically certified will also be offered to participants with a one-time genetic counseling session to review their results, free of charge using the Return of Genetic Research Results Template Letter. CSS will be responsible for informing clinic participants that their samples have been sequenced and offer to connect participant to the TSC Alliance for further information.

OTHER

Tissue donation after routine clinical procedure

Participants may elect to submit a tissue sample to the Biosample Repository following a medical procedure.

Trial Locations (24)

20910

RECRUITING

TSC Alliance, Silver Spring

63110

RECRUITING

Washington University in St. Louis, St Louis

77030

RECRUITING

Texas Childrens Hospital Baylor College of Medicine, Houston

90095

RECRUITING

University of California Los Angeles, Los Angeles

Unknown

RECRUITING

University of Alabama Birmingham, Birmingham

ACTIVE_NOT_RECRUITING

Loma Linda University Children's Hospital, Loma Linda

SUSPENDED

Jack & Julia Center for TSC, Oakland Children's Hospital and Research Center, Oakland

ACTIVE_NOT_RECRUITING

The Children's Hospital, Denver

RECRUITING

Nicklaus Children's Hospital, Miami

ACTIVE_NOT_RECRUITING

Chicago Comer Children's Hospital Neurogenetic Clinic, University of Chicago, Chicago

RECRUITING

University of Iowa Hospitals and Clinics, Iowa City

RECRUITING

Boston Children's Hospital, Boston

RECRUITING

Massachusetts General Hospital, Boston

RECRUITING

Minnesota Epilepsy Group, Roseville

RECRUITING

New York University Medical Center, New York

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

RECRUITING

Cleveland Clinic Foundation, Cleveland

ACTIVE_NOT_RECRUITING

University of Pennsylvania Medical Center, Philadelphia

RECRUITING

Le Bonheur Children's Hospital, Memphis

RECRUITING

Scottish Rite Hospital for Children, Dallas

RECRUITING

Memorial Hermann-Texas Medical Center (University of Texas Houston), Houston

RECRUITING

Children's National Medical Center, Fairfax

RECRUITING

Centre Hospitalier de L'Université de Montréal (Chum), Montreal

RECRUITING

Sainte-Justine Université de Montréal, Montreal

All Listed Sponsors
lead

National Tuberous Sclerosis Association

OTHER