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BIOREPOSITORY PROTOCOL EXEMPT FROM NCI REPORTING

UCI Specialty Area: Cancer

Principal Investigator: Angela Fleischman

Official Title: [BIOREPOSITORY] Hematologic Malignancies Biorepository for human research

A Study On:

Hodgkin's Lymphoma

Leukemia other

Lymphoid Leukemia

Multiple Myeloma

Mycosis Fungoides

Myeloid and Monocytic Leukemia

Non-Hodgkin's Lymphoma

Other Hematopoietic

Study Description

UC Irvine Medical Center is both a treatment and a research hospital. As a patient here, you may be treated

by some doctors who are also researchers performing studies to improve treatments currently available.

Scientists and clinicians at this institution are working together to discover new ways to treat cancer and

new ways to make current treatments safer and more effective. In order to conduct this research, we need

to study samples of normal and disease tissue obtained from normal volunteers and our patients. In order

to minimize the discomfort and risk to subjects, we are seeking to collect tissue that is left over from studies

that are required for your evaluation and care and are already being done. In certain circumstances (blood

draw and bone marrow aspiration) we are seeking to collect a small amount of tissue in addition to the

sample that would be collected for your routine care. Except for giving samples of blood, you will not be

asked to undergo any procedure solely for the purpose of obtaining a sample for this study.

You are being asked to take part in this research study because you have or are being evaluated for a

hematologic malignancy, bone marrow disorder, or immune system disorder.

This research study involves the collection and storage of blood and other tissue for later research testing.

It is not currently known how samples donated to the repository will be used at this time. These research tests may be developed during the time you are a patient at UC Irvine Medical Center, or in some cases, years later. Any researcher at UCI or their collaborators (including for-profit entities) may request permission to use samples from the repository. Frozen de-identified samples will be provided to researchers after their plans have been evaluated and approved by the UCI review board that oversees human research (IRB). These tests may provide additional information that will be helpful in understanding cancer and other diseases, but it is unlikely that what we learn from these studies will benefit you directly.

These studies may benefit other patients in the future. The research performed on these samples may

include the study of genetics, including the subject’s DNA code, parts or the DNA code or even whole

genome sequencing. Samples from the repository will not be used to create cell lines.

Eligibility

You can participate in this study if you have or are being evaluated for a blood disorder

You cannot participate in this study if you are pregnant.

A female nurse attentively holds a tablet, ready to assist with patient care and medical information.

Interested in Participating in this Trial?

Thank you for your interest with our team.

One of our specialists will be in contact with you soon.

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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.

You are being asked to participate in a clinical research potential participant database to identify
potential clinical research studies you may be eligible for. Participation in this database is voluntary.
You may choose to skip any question. You may refuse to participate or discontinue your involvement
at any time without penalty or loss of benefits. You are free to withdraw from this database at any
time. If you decide to withdraw from this database you should notify the research team
immediately.

You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health

We would like to interview you to learn more about your eligibility for current clinical research studies at UCI. The interview will last about 5-30 minutes, depending on the extent of your medical history.

Possible risks/discomforts associated with the database are hearing about potential clinical research studies that may not be of interest to you, invasion of your privacy, or a potential breach of confidentiality.

There are no direct benefits from participation in the database. However, this database may help inform you on clinical research studies that you may be eligible for. Participation in UCI clinical research studies help us gain important data and knowledge that may lead to improved treatment options for people with similar conditions to you in the future.

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

There is no compensation for your participation in this database.

There is no cost to you for participation in this database.

All information collected will be stored confidentially in a world-class securely-hosted application, “RealTime CTMS,” with robust data protections and encryption. This application has HIPAA compliant architecture and application rules to ensure data privacy and regulatory compliance.

Researchers will use your information to assess your eligibility for current and future clinical research studies at UCI. You may opt out at any time.

The research team, authorized UCI personnel, and regulatory entities, may have access to your study records to protect your safety and welfare.

While the research team will make every effort to keep your personal information confidential, it is possible that an unauthorized person might see it. We cannot guarantee total privacy.

Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information

Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.

If, during the course of this study, significant new information becomes available that may relate to your willingness to continue to participate, this information will be provided to you by the research team listed at the top of the form.

If you have any comments, concerns, or questions regarding the conduct of this research please contact the researchers listed at the top of this form

Please contact the UCI Institutional Review Board by phone, (949) 824-8170, by e-mail at IRB@research.uci.edu or at 160 Aldrich Hall, Irvine, CA 92697-7600 if you are unable to reach the researchers listed at the top of the form and have general questions; have concerns or complaints about the research; have questions about your rights as a research subject; or have general comments or suggestions.

What is an IRB?