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UNIVERSITY OF CALIFORNIA, IRVINE

CONSENT TO ACT AS A HUMAN RESEARCH SUBJECT

 

Assessing clonal hematopoiesis in Myeloproliferative Neoplasm families

 

Lead Researcher

Angela G. Fleischman M.D. Ph.D.

Department of Medicine

949-824-4144

 

STUDY LOCATION(S):

Sprague Hall B100

 

STUDY SPONSOR(S):

UC Irvine Health

 

 

Important Note: The information below includes a summary of key information about the research, presented first as required by the federal regulations.

 

Participation is Voluntary

You are being asked to participate in a research study.  Participation is completely voluntary.  Please read the information below and ask questions about anything that you do not understand.  A researcher listed above will be available to answer your questions.

 

Study Purpose

The purpose of this research study is to determine whether family members of patients with myeloproliferative neoplasm are more likely to have cells in their blood with mutations than people their age without family members with myeloproliferative neoplasm.

 

Study Procedures

You will be asked to fill out a survey about your medical history and family history, this can be done online, on the phone, or in person. You will then be asked to have blood drawn for genetic analysis. You will also be asked to provide a few fingernail clippings for genetic analysis as well. We ask for both blood and fingernails to identify genetic changes that are only in the blood but not in other tissues. You will also be asked to provide a stool sample.

  

Expected Duration

Participation will last approximately 1 hour to complete paperwork and draw blood. Both can be done at the same visit. We offer an optional follow-up visit to share your results with you. 

 

Risks of Participation

You are very unlikely to have side effects while on the study.  However, researchers don't know all the side effects that may happen.  Below is a description of potential side effects and risks of the study:

·       Mild discomfort or bruising from a blood draw

·       Slight discomfort from taking a small fingernail clipping

·       Emotional stress from learning genetic information about yourself

 

Benefits to Participants

You will not directly benefit from participation in this study.

 

Benefits to Others or Society

This study will help researchers learn more about myeloproliferative neoplasm, and it is hoped that this information will help in the prevention and treatment of future patients with blood cancers.

 

Alternative Procedures or Treatments

There are no alternative treatments or procedures available.  The only alternative is not to participate in this study.

 

 

WHY IS THIS RESEARCH STUDY BEING DONE?

The purpose of this research study is to determine whether family members of patients with myeloproliferative neoplasm are more likely to have cells in their blood with mutations than people their age without family members with myeloproliferative neoplasm.

 

We are asking for your permission to collect samples and health information from you for a research study to help determine why some blood cancers run in families. Your blood and tissue samples contain DNA, which makes up the genes that serve as the "instruction book" for the cells in our bodies. Your samples and health information will help us study why blood diseases run in families. Specifically, in blood cancers cells which have mutations expand and take over the blood system and crowd out healthy blood cells. However, we are learning now that it is common (about 10-15% of people over age 65) for people to have cells in their blood that have acquired mutations without blood cancer. Why blood cells with mutations sometimes develop into a blood cancer and other times do not is unknown, and we are trying to understand this. We predict that the tendency to develop mutations in the blood may run in families and that people in the same family may develop similar mutations. To do this we will perform DNA sequencing on your blood and also on non-blood cells from fingernail clippings.  This will allow us to identify acquired mutations in your blood by seeing what DNA sequences are different in your blood cells than your non-blood cells. We will store your samples, genomic data, and health information, and share them, now and in the future, with researchers who are studying a variety of different topics or diseases. We hope that this knowledge could be used to identify why blood cancers such as myeloproliferative neoplasm run in families and we are hoping this work may lead to therapeutic strategies to prevent the development of myeloproliferative neoplasm and other blood cancers. This study is being performed by UC Irvine. The DNA sequencing is being provided by Tempus, Inc.

We have created an instructional video with more background information about our study here: 

You can learn more about this study, including major findings resulting from the research, on our websites www.wearempn.org or www.mpnlab.org

 

HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY? 

Approximately 150 participants will take part in the research at UCI.

 

AM I ELIGIBLE TO PARTICIPATE IN THIS STUDY?

Please note this may not be a complete list of eligibility criteria. We have included a few examples of study criteria to help you better understand how your eligibility in the study will be determined; your study team will go through the study eligibility criteria with you to verify if you qualify for participation in this study.

 

Any adult who belongs to a family containing at least two members with myeloproliferative neoplasm, or one family member with myeloproliferative neoplasm (MPN) and another member with a different malignancy. myeloproliferative neoplasm is a blood condition where people produce too many blood cells such as red blood cells, platelets, or white blood cells. Myeloproliferative neoplasms include polycythemia vera (PV), essential thrombocytosis (ET), and myelofibrosis (MF).

 

The choice to participate in this research by contributing your samples, genomic data and health information is completely up to you. No matter what you decide to do, your decision will not affect the medical care or benefits to which you are otherwise entitled. 

 

You can participate in this study if you:

·       Are at least 18 years old,

·       Belong to a family with at least two family members with myeloproliferative neoplasm or one member with myeloproliferative neoplasm and another with a different malignancy, and

·       Are willing to provide a blood sample as well as a urine or fingernail clipping sample.