Understanding Your Participation

Understanding Your Participation

For the purpose of this Consent “the participant” will refer to the person diagnosed with lymphangiomatosis or Gorham's disease or any of these Eligible Diagnoses. “You” will refer to the person entering the information. This may be the participant or a family member or guardian of the participant (the person legally responsible for the care and maintenance of the participant).
 
We are asking you to enter personal and other information into the International LGDA Registry for Lymphatic Malformations (which we will call The Registry). It is important that we explain what is involved and what will be done with the information you provide. This section contains answers to questions about the information we want, why we want the information, how it might benefit you, and possible risks of giving us this information. After you have reviewed “Understanding Your Participation” you will be directed to the Registration and Consent form where you will create an account and asked a series of questions. If you answer, “yes” to these questions regarding participation and use of the information you are providing you will have “consented.” Participation is optional. If you have questions that are not answered in this document, please contact the registry coordinator at: This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

What is a registry and what is its value?

Scientific advances have led to valuable improvements in diagnosis and treatment of many disorders. Unfortunately, these advances have not yet led to better diagnosis and treatment for lymphangiomatosis & Gorham’s disease. One reason for this is because lymphangiomatosis & Gorham’s disease are so rare that most doctors have never seen a case.    

A patient registry is a place where medical information, family history, and other related information about patients is collected and stored for use in medical research. To get researchers interested in studying lymphangiomatosis and Gorham’s disease, and other lymphatic malformations and osteolytic bone diseases, it is critically important to have as much information as possible about a large group of patients affected by these diseases collected together in a single registry database.    

One of the most important steps towards finding effective treatments for a disease is to uncover its natural history. Natural history is a term that refers to the ways diseases behave: what kinds of symptoms are commonly seen and if there is any pattern in the ways in which they appear; how the symptoms progress; if any disabilities result; if the patients have any other conditions in common; and what complications arise.    

As more is learned about lymphangiomatosis and Gorham’s disease, new potential treatments will emerge and it will become necessary to test them in what are known as clinical trials. When a clinical trial is planned, it is very important that patients eligible for the trial be found and contacted quickly so the clinical trial can be implemented; having a central patient registry makes this possible.

Who is eligible to join the Registry?

Individuals eligible to join the International LGDA Registry for Lymphatic Malformations include those persons diagnosed with lymphangiomatosis and/or Gorham's disease or any of these several names by which these conditions are known.

The registry is also open to those diagnosed with non-specific lymphatic malformations and osteolytic bone diseases including, but not limited to, lymphangiectasia, Hypophosphatasia (HPP), and Osteogenesis Imperfecta. If you are interested in joining the Registry but not sure if your diagnosis is eligible email the Registry Coordinator ( This e-mail address is being protected from spambots. You need JavaScript enabled to view it ) and we will help you determine if you can join.

The registry seeks to include both living patients and those who have died from complications of these conditions or other causes. Data collected about patients who have died is extremely important in helping to understand the natural history of these diseases and we encourage parents (or other surviving family members) of these individuals to join the Registry.

Do I have to live in or receive treatment in the United States to participate in the Registry?

No. The International LGDA Registry for Lymphatic Malformations is open to patients from every country in the world.  The LGDA currently communicates with patients in Africa, Asia, Australia, Europe, North America. and South America.

How can I participate in the Registry?

Patients who have reached the legal age of being an adult, based on local laws (18 years in most U.S. states) who can understand the consent form (and who do not have a legal guardian) can join the Registry on their own. Otherwise, the parent, legal guardian, or custodian of the patient must give consent and enter the patient’s information in the Registry. When the patient turns reaches the age of adulthood and if he or she is able or no longer requires a guardian, consent will be obtained directly from the patient so he or she can continue to participate in the Registry. Some adults with lymphangiomatosis and Gorham’s disease may need someone’s help to answer the questions – it’s okay to provide that help.    

A parent, spouse, or child of a patient who has died of lymphangiomatosis or Gorham’s disease may also create an account and create a Patient Profile in the Registry.

What type of information will be collected in the Registry?

In addition to basic demographic information about the patient (and the patient’s parent/guardian, where applicable), the Registry will collect the following information about the patient:

  • information about both the patient’s general health and the lymphangiomatosis/ Gorham’s disease diagnosis,         
  • the patient’s daily activities and how they are impacted by the diagnosis, and    
  • the care the patient receives or has received.     

This registry does not involve any treatment; just the collection of information. 

What happens to the information I put in my profile and who has access to it?

The goal of the Registry is to create a central bank of information that fosters research, while maintaining the highest standards for protecting your privacy. This is done by “de-identifying” the information you have entered. De-identifying data removes anything that could be used to identify the patient and the registered account holder, including name, address, and other personal information that would allow someone to discover who you are and where you live and replaces it with a code number that is stored in a secure place and protected with a password. De-identified data shields the identities of the people the data is about, so that it cannot be traced to a person.    Only authorized Registry staff will know that you have entered information or be able to see your contact information. Your identifiable information will not be shared with anyone outside the Registry (unless you give your permission to share it).

From time to time de-identified data reports from the Registry may be made available to the lymphangiomatosis and Gorham’s disease community. For example, a chart showing the number of people in the Registry in a given age range or who have the same type of symptoms or are taking a certain medication may be included in newsletters or on the LGDA website. De-identified data will also be provided to the medical community in the hope that the information will lead to improvements in patient care and breakthroughs for new treatments.    

How is my privacy protected?

The information you enter in the Registry will be maintained in a secure database stored on secure servers located in the USA. The Registry uses a web-based software program built by Innolyst, Inc./PatientCrossroads, a US software company which is the authorized contractor for the NIH/NCATS/ORDR in the development of rare disease global registries. The program was designed in accordance with applicable US privacy protection provisions of HIPAA (Health Insurance Portability and Accountability Act of 1996). Innolyst, Inc., has developed and secured over 200 disease registries for the National Institutes of Health, patient advocacy groups, and other disease research organizations.

Any personal information that could be used to identify you or your family is labeled with a special code. The code is securely stored with a password. Only authorized Registry staff will be able to access the code and contact you if needed. Information in the Registry that has had all of the personally identifying information changed to a code is called “de-identified.”

The Lymphangiomatosis & Gorham’s Disease Alliance (LGDA) owns the information contained within the Registry. To ensure that the rights and welfare of participants will be protected, an independent ethics committee, Chesapeake Research Review, Inc. (Chesapeake IRB), has approved the International LGDA Registry for Lymphatic Malformations Registry informed consent process.

Located in Columbia, Maryland, USA, Chesapeake IRB has been providing independent IRB services for major pharmaceutical companies, universities, individual researchers, academic medical centers, and community hospitals since 1993. Chesapeake IRB is accredited by The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP).

How is the information in the Registry shared with researchers?        

Your de-identified data will be shared with other research databases, including the Global Rare Disease Patient Registry and Data Repository (GRDR), to help develop global knowledge of lymphangiomatosis/Gorham’s disease/lymphatic malformations that may lead to new research studies, clinical trials, and improved care.

Scientists, researchers, and clinicians whose projects have been approved by an institutional review board (IRB) and comply with the legal requirements for patients’ protection will be allowed to see the de-identified information in the Registry and may search the de-identified data for patients for their studies.

If a patient looks like a good match for a study and the researcher wants to contact you, he or she can do so only through the Registry. The researcher will submit a contact request form to the Registry staff who will then provide you with the researcher’s contact information. You can then choose to contact the researcher directly if you want to learn more. The Registry will not release your name or any other information that may reveal your identity to the researcher. If you choose to contact the researcher, they can answer any questions you have about the study and determine if you or your child (or family member) are eligible to participate.         

Your participation in the Registry does not guarantee that you will be accepted into any research study or clinical trial.

Will I need to provide the Registry with additional information in the future?

Yes. The Registry is most valuable for research when it is up-to-date. Your Patient Profile can be updated at any time, for example if the patient moves; there is a change in the patient’s health, medications, or a new symptom; or the patient changes doctors or adds a new one. New sets of questions may be added to the Registry periodically to deepen the level of information being collected about lymphangiomatosis and Gorham’s disease and how it affects patients. You will also be able to upload test results to your profile or send them to the Research Coordinator to be entered manually.

The Registry will update you periodically about new developments in the lymphangiomatosis and Gorham’s disease community, new research, and clinical trials. We ask that you update your registry information at least once per year. The registry will send you a reminder at least once each year. Please update your profile if you move, change your email address or phone number.      

I am creating a  profile for my child who is under age 18. What happens when my child turns 18?

When a minor Participant reaches age 18 (or age of adulthood per local laws) and no longer requires a guardian, consent shall be obtained directly from the Participant so he or she can continue to participate in the registry. Should the Participant then choose not to re-consent his or her data will be removed from the Registry. However, data previously assigned to research projects cannot be retrieved.

Are there any costs to participate in the Registry?

No.

Am I required to participate in the Registry?

No. Participation in this registry is entirely voluntary and you are free to withdraw from the registry at any time without having to provide any explanation. Simply contact the registry and all of your data will be removed from the database. Data accessed or assigned to a specific study prior to your request for removal cannot be retrieved from researchers that have already accessed it. Failure to update a profile shall not result in the deletion of the profile and will not be considered a withdrawal of consent to use the data contained therein in the manner described in the consent.
        
How will I benefit from participating in the Registry?

Participants may receive information about opportunities to participate in research, clinical trials, information about medical advances, and other news from the Registry.

Participation may not benefit you personally or medically. No one is paid for their participation in the registry. However, your participation may help you or your child and others with lymphangiomatosis and Gorham’s disease or other diseases by increasing the understanding of lymphangiomatosis and Gorham’s disease. Collected data may help speed up research by collecting information scientists can use. Researchers may learn whether and how treatments work. Medical professionals may be able to improve how they diagnose and treat these diseases.

Are there any risks involved in participating in the registry?        

There is minimal risk in taking part in the registry. The registry includes questions that can be sensitive and you may feel uncomfortable answering. You do not have to share any information you do not want to. Another unlikely risk is potential breaches in the computer system. In the unlikely event there is a breach in the registry’s computer system all participants will be notified.   

I want to be involved in a clinical trial. If I register, is this guaranteed?

Although one of the main goals of the Registry is to make it easier for affected individuals to participate in research, there is no guarantee that those participants will be eligible for a trial.         

Please note that even if the coordinators of a clinical trial believe that you might be eligible for the trial, based on the data about you stored in the Registry, it is still possible that later on it will turn out that you do not meet the trial requirement criteria after all. Please also be aware that if we inform you about the existence of a trial, this does not imply that we endorse it. In order to participate in any trial, you will need to discuss with the research staff about the trial and fill out a separate informed consent form.     

I don’t want to be involved in a clinical trial. Should I still register?

Absolutely. We hope that you will still be willing to register even if you don’t want to take part in a trial. Information about each and every patient with lymphangiomatosis and Gorham’s disease is critically important to researchers who are trying to learn more about how these diseases behave in order to discover their cause.

What are my options if I do not want to be in the Registry?

You do not have to join this registry. Participation is voluntary. You do not need to participate in this Registry to remain a member of the lymphangiomatosis and Gorham’s disease community. Your decision to participate in this registry or not will not affect your healthcare.   

Is there a tissue bank connected to the Registry?

Yes.  The LGDA has partnered with the National Disease Research Institute (NDRI) to store biospecimens such as blood and tissue donated by patients with lymphangiomatosis and Gorham’s disease. The NDRI is the United States’ premier source of research tissue. By serving as the liaison between tissue and organ donors and the scientific community, NDRI is uniquely positioned to support breakthrough research in rare diseases like lymphangiomatosis and Gorham’s disease.

Through the donation of blood, bodily fluids, and tissue collected when a patient is undergoing a procedure (for example having a biopsy performed, draining fluid from the chest, or routine blood draw) Registry participants can impact scientific breakthroughs. There’s no cost, and your donation could make the difference for those with lymphangiomatosis and Gorham’s disease and many other rare and as-of-now untreatable diseases.                

If you would like more information about blood and tissue donation contact the Registry at This e-mail address is being protected from spambots. You need JavaScript enabled to view it .
    
Do I have to donate tissue to NDRI to participate in the Registry?

No. Providing your information to the registry, contributing blood or other samples, and participating in the Registry is voluntary. However, we encourage all participants to donate biospecimens as these are essential to research into the causes and potential treatments of these rare diseases. If you decide to donate your samples, you will need to provide separate consent for the biobank (lab).

Who do I contact with questions?    

If you have any questions about the registration process or about participation in the registry, please contact the Registry at This e-mail address is being protected from spambots. You need JavaScript enabled to view it . For additional information regarding the terms and conditions of this web site or the privacy policy please go to Terms and Conditions and Privacy Policy sections of this website.

If you have any questions or complaints about your rights as a research participant contact Chesapeake IRB, at 410-884-2900 (collect), by email at This e-mail address is being protected from spambots. You need JavaScript enabled to view it , or by mail at Study Subject Adviser, Chesapeake IRB, 7063 Columbia Gateway Drive, Suite 110, Columbia, MD 21046. An  IRB  (Institutional Review Board) is a group of people who review research studies to protect the rights and welfare of research participants.

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