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What is the Alpha-1 Research Registry?

The Alpha-1 Research Registry is a confidential database made up of individuals diagnosed with Alpha-1 Antitrypsin Deficiency (Alpha-1) and individuals identified as Alpha-1 carriers. The Registry was established to facilitate research initiatives and promote the development of improved treatments and a cure for Alpha-1. Located at the Alpha-1 Foundation, Miami, FL, the Registry employs procedures that ensure the most stringent confidentiality of participants. The Registry is under the direction of Jeanine D’Armiento, Chair of the Alpha-1 Foundation’s Board of Directors and is guided by an Advisory Committee comprised of leaders in the medical, ethical, scientific and Alpha communities. Individuals enrolled in the Registry have the ongoing opportunity to participate directly in clinical trials of new therapeutic approaches in addition to other research opportunities.

Who is eligible to enroll in the Registry?

  • Individuals of all ages who are diagnosed with Alpha-1.
  • Individuals identified as carriers of Alpha-1.
  • The Alpha-1 Research Registry is currently open to residents of the United States only. International individuals are not eligible to join at this time.

How do I enroll in the Registry?

Individuals interested in joining the Alpha-1 Research Registry can enroll in one of three ways: via the Registry Portal, via hard copy or via DocuSign™.

OPTION 1: Alpha-1 Research Registry Portal

To join the Alpha-1 Research Registry, visit the Registry Portal page by clicking on the following link:  Research Registry Portal

STEP 1: Complete the Registration Form

  • All participants interested in joining the Alpha-1 Research Registry must complete a registration form.
  • If you are the parent or guardian who will be enrolling your child or minor in the Research Registry, please provide your contact information.

STEP 2: Read and Sign the Adult or Parental Informed Consent

  • Please read and review the informed
  • If you are the parent or guardian enrolling a child or minor in the Alpha-1 Research Registry, please provide your email address and provide your child or minor’s name.
  • You will have an opportunity to review your informed consent and response.
  • After you have reviewed your information, you will have the option of downloading and/or printing your informed consent and keeping a copy for your records. If you would like a copy of your fully signed informed consent please contact the Alpha-1 Foundation at 877-228-7321 ext. 252 or email at alpha1registry@alpha1.org.

STEP 3: Complete the Questionnaire

  • Answer all the questions to the best of your ability.
  • You will have the option to save your response and return to the questionnaire at any time if you are unable to complete the questionnaire in one sitting.
  • At the end of the questionnaire, you will have the option to download a copy of your completed questionnaire for your records.

STEP 4: Provide Medical Tests and Labs

  • We request that you provide up to 5 reports of each medical test and lab listed below. If you don’t have 5 reports for each test, we will accept whatever you can provide:
    • Pulmonary Function Test reports
    • Liver biopsy reports
    • Fibroscan reports
    • Lung and/or liver radiology imaging reports (reports from the scans or images, not the scans or images themselves)
    • Exercise test/6 minute walk test reports
    • Lab reports that include INR, GGT, total cholesterol, triglycerides, HDL and LDL.
  • You do not need to conduct any new tests. We request the reports from tests and labs already conducted
  • You can upload electronic copies, screenshots or pictures of your reports to the Portal.
  • You can also email or mail copies, screenshots or pictures of your reports to an Alpha-1 Registry Coordinator.
  • When applicable, you may submit your test and lab reports in-person to a Registry Coordinator.
  • Your reports will be securely uploaded into the Registry database by Alpha-1 Foundation Research Registry Coordinators.
  • Here is a link to learn how to obtain your medical tests and labs from your physician or healthcare organization: http://bok.ahima.org/doc?oid=300996#.Xs_5MxNKhTZ
  • You may incur a fee when obtaining the reports of your medical tests and labs from your physician or healthcare organization. The Alpha-1 Foundation will reimburse you up to and no more than $25 for the expense. The reimbursement will be made after you upload, email or mail the reports of your medical tests and labs.

 

If you have any questions, please call the Alpha-1 Research Registry at 877-228-7321 ext. 252 or email at alpha1registry@alpha1.org.

OPTION 2: Request a Hard Copy

  • If you are unable to complete the informed consent and questionnaire through the patient portal and would like to request a hard copy of the informed consent or questionnaire, you can call the Alpha-1 Research Registry department at 1-877-228- 7321 ext. 252 or email at alpha1registry@alpha1.org.
  • After you have signed an informed consent and completed the questionnaire, you will be asked to submit the reports of various medical tests and labs.
  • We request that you provide up to 5 reports of each medical test and lab listed below. If you don’t have 5 reports for each test, we will accept whatever you can provide:
    • Pulmonary Function Test reports
    • Liver biopsy reports
    • Fibroscan reports
    • Lung and/or liver radiology imaging reports (reports from the scans or images, not the scans or images themselves)
    • Exercise test/6 minute walk test reports
    • Lab reports that include INR, GGT, total cholesterol, triglycerides, HDL and LDL.
  • You do not need to conduct any new tests. We request the reports from tests and labs already conducted
  • You can upload electronic copies, screenshots or pictures of your reports to the Portal.
  • You can also email or mail copies, screenshots or pictures of your reports to an Alpha-1 Registry Coordinator.
  • When applicable, you may submit your test and lab reports in person to a Registry Coordinator.
  • Your reports will be securely uploaded into the Registry database by Alpha-1 Foundation Research Registry Coordinators.
  • Here is a link to learn how to obtain your medical tests and labs from your physician or healthcare organization: http://bok.ahima.org/doc?oid=300996#.Xs_5MxNKhTZ
  • You may incur a fee when obtaining the reports of your medical tests and labs from your physician or healthcare organization. The Alpha-1 Foundation will reimburse you up to and no more than $25 for the expense. The reimbursement will be made after you upload, email or mail the reports of your medical tests and labs.

OPTION 3: DocuSign™ and Download Questionnaire

Simply sign the informed consent and complete the Contact Information Form contained in one the following links. We are using DocuSign™ as the means to sign informed consents online. DocuSign™ is a HIPAA compliant partner.

STEP 1: Instructions for signing the informed consent and completing the Contact Information Form:

Click on one of the following links:

Subjects who are 18 years or older: Adult Informed Consent

Parental Consent for subjects who are less than 18 years old: Informed Consent

  1. You will be prompted to provide your name and email address. Enter each and click Begin
  2. You will be prompted to verify your email address. Check your email account for an email from DocuSign™ containing a validation code. Copy the validation code and go back to the screen that asked for the validation code. Enter the validation code and click Validate
  3. After your email is validated, you will be brought to the informed
  4. Read the electronic record and signature disclosure policy contained in the link. If you agree, check the box that you agree to use electronic records and signatures and click
  5. Read the informed
  6. If you agree to participate in the Alpha-1 Research Registry, answer the questions by clicking the appropriate check
  7. Click on the Sign sticky. A computer-generated signature will be created for you. Click Adopt and
  8. Complete the Alpha-1 Research Registry Contact Information Form on the last page.
  9. After you have answered the questions, signed the informed consent and completed the Contact Information Form, click Finish at the bottom of the
  10. You will be prompted with the option of printing or downloading the partially signed informed
  11. The Alpha-1 Foundation Research Registry staff will receive a copy of the partially signed consent. The Foundation’s Registry staff will sign the informed consent and a fully signed copy of your informed consent will be emailed to
  12. You are now a participant in the Alpha-1 Research Registry! The next step is to complete the Alpha-1 Research Registry Questionnaire.

 

STEP 2: Complete the Alpha-1 Research Registry Questionnaire

  1. Click the following link: Alpha-1 Research Registry Questionnaire
  2. Print the questionnaire and answer all of the
  3. Mail the completed questionnaire to the following address:

Alpha-1 Research Registry c/o
Alpha-1 Foundation Attn:
Registry Staff
3300 Ponce de Leon Boulevard
Coral Gables, FL 33134

The Alpha-1 Foundation’s Registry staff will input the data you provided in the questionnaire into the Registry database. We are in process of developing the medical records portion of the portal. We will inform you when it is available.

 

STEP 3: Submit Medical Tests and Labs:

  • We request that you provide up to 5 reports of each medical test and lab listed below. If you don’t have 5 reports for each test, we will accept whatever you can provide:
    • Pulmonary Function Test reports
    • Liver biopsy reports
    • Fibroscan reports
    • Lung and/or liver radiology imaging reports (reports from the scans or images, not the scans or images themselves)
    • Exercise test/6 minute walk test reports
    • Lab reports that include INR, GGT, total cholesterol, triglycerides, HDL and LDL.
  • You do not need to conduct any new tests. We request the reports from tests and labs already conducted
  • You can upload electronic copies, screenshots or pictures of your reports to the Portal.
  • You can also email or mail copies, screenshots or pictures of your reports to an Alpha-1 Registry Coordinator.
  • When applicable, you may submit your test and lab reports in person to a Registry Coordinator.
  • Your reports will be securely uploaded into the Registry database by Alpha-1 Foundation Research Registry Coordinators.
  • Here is a link to learn how to obtain your medical tests and labs from your physician or healthcare organization: http://bok.ahima.org/doc?oid=300996#.Xs_5MxNKhTZ
  • You may incur a fee when obtaining the reports of your medical tests and labs from your physician or healthcare organization. The Alpha-1 Foundation will reimburse you up to and no more than $25 for the expense. The reimbursement will be made after you upload, email or mail the reports of your medical tests and labs.

Frequently Asked Questions

Who will have access to my name? How confidential is this database?

Your questionnaire will go directly to the Registry Coordinating Center at the Alpha-1 Foundation. There is strict adherence to established confidentiality procedures that are intended to protect the identity of those who participate. The Registry is required to conceal a member’s identity and personal information from researchers and organizations unless consent is granted by the Registry member. The database is kept under tight security at all times. This means that it is password protected and inaccessible from the Internet. Also, all hard copies of personal information are kept under lock and key. Only the Registry staff at the Alpha-1 Foundation have access to a member’s personal information.

 

How can my participation help promote research?

One of the largest obstacles in Alpha-1 research is finding a sufficient number of volunteers to participate in studies. By establishing a database of thousands of people with Alpha-1 and promoting its use to the Alpha-1 research community, the Registry will allow new therapies and important research studies to be evaluated. Participation in research is voluntary and Registry members are always given the option to accept or decline research invitations.

 

The benefits of joining the Alpha-1 Research Registry:

  • Participate in clinical trials for new treatments.
  • Be part of survey studies to determine health care costs, environmental risks, and assist in collection of other specific data to advance scientific and medical knowledge about Alpha-1.
  • Access to experts in Alpha-1 clinical care.
  • Update Newsletter with information on latest research activities.

 

What should I do if I have signed an informed consent since June 2019?

Individuals who have signed an informed consent since June of 2019 either at the Alpha-1 National Conference, via DocuSign™, or via mail, your informed consent is on file at the Alpha-1 Foundation. A separate email will be sent to you with a link to register for the Alpha-1 Research Registry and complete the patient questionnaire.

If I was enrolled in the registry at the Medical University of South Carolina, how does that affect my participation in the new Alpha-1 Research Registry at the Alpha-1 Foundation?

Even if you were enrolled in the Alpha-1 Registry at the Medical University of South Carolina, you will need to sign an informed consent to participate in the Alpha-1 Research Registry at the Alpha-1 Foundation. The Alpha-1 Research Registry is collecting more robust data that may be valuable to researchers and investigators.

For more information, please contact the Alpha-1 Research Registry at 877-228-7321 ext. 252 or alpha1registry@alpha1.org

The Alpha-1 Coded Testing (ACT) Study

The goal of the ACT Study is to provide free, confidential testing services and facilitate research on genetic testing. The test is administered through a research study which evaluates perceived risks and benefits of genetic testing. Anyone can ask to be tested. The ACT Study provides a way for family members of Alphas and others at risk to learn their Alpha-1 genotype. Enrollment into the study may end at any time. The ACT Study is sponsored by the Alpha-1 Foundation. For more information, alpha1lab@alphaone.ufl.edu call toll free 1-855-476-1227.

For more information about the Alpha-1 Research Registry, please contact the Alpha-1 Foundation at 877-228-7321 ext. 252 or alpha1registry@alpha1.org. 

International listing of Alpha-1 research studies

The U.S. National Institutes of Health (NIH) lists Alpha-1 research studies in the United States and around the world at ClinicalTrials.gov.

The NIH describes the Clinical Trials site:

ClinicalTrials.gov is a registry of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov gives you information about a trial’s purpose, who may participate, locations, and phone numbers for more details. This information should be used in conjunction with advice from health care professionals.

You can find clinical trials for Alpha-1 by typing “Alpha-1 Antitrypsin Deficiency” into the search box. (You can just type “Alpha-1″ and get a lot of results — but many trials will appear that have nothing to do with Alpha-1 Antitrypsin Deficiency.)

Please note the important NIH caution if you should consider volunteering for one of these studies: “This information should be used in conjunction with advice from health care professionals.” It’s always a good idea for an Alpha to see a doctor who’s familiar with Alpha-1 and discuss the risks and benefits before joining a clinical trial.

Also keep in mind that many of these clinical trials will not be available in your area and that you may not qualify for them. If you are a member of the Alpha-1 Research Registry, that research is already done before you get a notice about a new trial.

For more information, please contact the Alpha-1 Research Registry at 877-228-7321 ext. 252 or alpha1registry@alpha1.org. Call or email us to receive a free subscription to the Alpha-1 Research Registry Research Update.

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