TSC Biosample Repository and Natural History Database
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorNational Tuberous Sclerosis Association
About this trial
The TSC Biosample Repository collects and stores samples of blood, DNA, and tissues that scientists can request to use in their research. The samples we collect are all linked to clinical data in the TSC Natural History Database. The TSC Natural History Database captures clinical data to document the impact of the disease on a person's health over his or her lifetime. This data may be collected retrospectively or prospectively.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of tuberous sclerosis complex or lymphangioleiomyomatosis (sporadic LAM).
Disqualifiers
None
Trial population
An individual must have a diagnosis of tuberous sclerosis complex, based on the current clinical and genetic diagnostic criteria. The individual may enroll if they have a diagnosis of sporadic LAM. All persons with tuberous sclerosis complex are eligible to participate, such as individuals with limited decisional capacity.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Phlebotomy
Procedure/SurgeryParticipants may elect to submit a blood sample to the Biosample Repository.
Buccal (cheek) swab
Procedure/SurgeryParticipants may elect to submit a buccal swab sample to the Biosample Repository.
Genetic Testing
GeneticBiosamples 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.
Tissue donation after routine clinical procedure
Other interventionParticipants may elect to submit a tissue sample to the Biosample Repository following a medical procedure.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Natural History data and biosamples including blood, tissue, or other types of biological samples from individuals with TSC
The purposes of this project are to: * Collect biosamples such as blood, tissue, fluid, or other types of bodily samples from people with TSC. * Collect information about people with TSC over their lifetime.
Time frame
Average 15 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov