RecruitingOBSERVATIONAL

TSC Biosample Repository and Natural History Database

This project, called the TSC Biosample Repository and Natural History Database, is gathering samples such as blood, DNA, and tissues from people with Tuberous Sclerosis Complex (TSC) or a condition called Lymphangioleiomyomatosis (LAM). These samples are stored and can be shared with scientists worldwide for their research. We also collect health information over time to see how the conditions affect people's bodies. The main goal is to learn more about TSC and LAM, which could lead to new ways to treat problems affecting organs like the brain, kidneys, heart, lungs, and skin. By providing samples and information, you'd be helping researchers better understand these conditions.

At a glance

Status

Recruiting

Sponsor

National Tuberous Sclerosis Association

Enrolment target

5,000

Start

01 Jan 2016

Estimated completion

01 Dec 2050

Tuberous Sclerosis Lymphangioleiomyomatosis

What is this study about?

This project is a big effort to learn more about Tuberous Sclerosis Complex (TSC) and a related lung condition called Lymphangioleiomyomatosis, or LAM. Think of it like building a huge library of information and materials.

First, there's the 'Biosample Repository'. This is where physical samples are collected, such as blood, DNA (which carries your genetic information), and even small pieces of tissue if you're having a routine medical procedure. These samples are stored carefully in a special bank. Then, there's the 'Natural History Database'. This part collects health information about people with TSC or LAM, sometimes from past medical records and sometimes by keeping track of their health over many years. All the samples are linked to this health information.

The main idea is that by having lots of different samples and detailed health information all in one place, scientists around the world can ask to use them. This helps them study TSC and LAM in new ways. By combining these samples with health details, they hope to get a much clearer picture of how these conditions affect different parts of the body, like the brain, kidneys, heart, lungs, and skin. This deeper understanding is crucial for finding new and better treatments in the future.

Key takeaways

This project aims to understand Tuberous Sclerosis Complex (TSC) and LAM better.
It collects blood, DNA, and tissue samples.
It also gathers health information over time.
Your samples and data will help scientists worldwide.
Participation involves low risk and helps future medical advancements.
Your privacy is protected, and you can withdraw anytime.

Who may be eligible?

To take part in this project, you need to have received a diagnosis of Tuberous Sclerosis Complex (TSC) from your doctor. Also, people who have been diagnosed with a condition called Lymphangioleiomyomatosis (LAM) can join.

There are no specific reasons that would stop you from taking part, other than not having one of these diagnoses. The project welcomes people of all ages and genders.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have a doctor's diagnosis of Tuberous Sclerosis Complex (TSC)?
Or, do I have a doctor's diagnosis of Lymphangioleiomyomatosis (LAM)?
Am I willing to provide blood or cheek swab samples?
Am I comfortable with my health information being used for research (with personal details removed)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be asked to provide some biological samples. This might involve giving a blood sample, similar to what you might do for a regular check-up. You might also be asked for a cheek swab, which is a simple and painless way to collect cells from the inside of your mouth. For some people, if you are already having a routine medical procedure that involves removing tissue, you might be asked if a small part of that tissue can also be used for this project.

Beyond providing samples, the project also collects information about your health over time. This data might come from your existing medical records or by collecting new information as you go about your life. There are no specific visits or medications required just for this study; it's mostly about providing samples and allowing your health information to be included. The samples can be collected at a special clinic, at your home, or even at an educational meeting. This project aims to collect information over a long period, potentially over your lifetime, to understand the conditions better.

Potential risks and benefits

The main benefit of taking part is contributing to a better understanding of Tuberous Sclerosis Complex and LAM, which could lead to new treatments for future patients. The risks are generally low, mainly involving the minor discomfort of a blood draw or providing a cheek swab. Your genetic information will be part of the samples, but all your personal details that could identify you will be removed before scientists use the information. You have the right to withdraw from the project at any time without giving a reason, and this will not affect your medical care.

Locations (26)

University of Alabama Birmingham
Verified postcode
Birmingham, United States· Recruiting
Loma Linda University Children's Hospital
Verified postcode
Loma Linda, United States· Recruiting
University of California Los Angeles
Verified postcode
Los Angeles, United States· Recruiting
Jack & Julia Center for TSC, Oakland Children's Hospital and Research Center
Verified postcode
Oakland, United States· Completed
The Children's Hospital
Verified postcode
Denver, United States· Recruiting
Nicklaus Children's Hospital
Verified postcode
Miami, United States· Recruiting
Chicago Comer Children's Hospital Neurogenetic Clinic, University of Chicago
Verified postcode
Chicago, United States· Recruiting
University of Iowa Hospitals and Clinics
Verified postcode
Iowa City, United States· Recruiting
TSC Alliance
Verified postcode
Silver Spring, United States· Recruiting
Boston Children's Hospital
Verified postcode
Boston, United States· Recruiting
Massachusetts General Hospital
Verified postcode
Boston, United States· Recruiting
Minnesota Epilepsy Group
Verified postcode
Roseville, United States· Recruiting

Common questions

What is the main goal of this project?

The main goal is to collect samples and health information from people with Tuberous Sclerosis Complex (TSC) or LAM to help scientists understand these conditions better and find new treatments.

What kind of samples will be collected?

They will collect samples like blood, DNA (from a cheek swab), and potentially tissue if you're having a routine medical procedure.

Will my personal details be kept private?

Yes, all personal identifying details will be removed from your health information and samples before scientists use them for research.

Do I need to visit a special clinic repeatedly?

Not necessarily. Samples can be collected at clinics, your home, or other locations. There are no special follow-up visits or medications required for the study.

Can I stop participating if I change my mind?

Yes, you can choose to withdraw from the project at any time, and it will not affect your medical care.

How to find out more

Elizabeth Cassidy, MPH

ecassidy@tscalliance.org 301-562-9890 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.