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Blood Collection Protocol for the Analysis of Exosomes in Patients with Breast Cancer

UCI Specialty Area: Cancer
Principal Investigator: Ritesh Parajuli
Official Title: Blood Collection Protocol for the Analysis of Exosomes in Patients with Breast Cancer
A Study On:
Breast

Study Description

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

and find tests that could detect recurrence early on. The purpose of this research study is to determine

a group of particles in the blood called exosomes that may be associated with response to treatment

or could predict recurrence and side effects.

Eligibility

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.

You can participate in this study if you:

  • Are female
  • Over the age of 18
  • Ability to understand and the willingness to sign a written informed consent document
  • Consent to be in the study, signed and dated an approved consent form, which conforms to federal and institutional guidelines.
  • For cancer patients, you must have either Stage I, Stage II, Stage III or Stage IV Breast cancer
  • For cancer patients, you must have either hormone Receptor +, Her-2 receptor positive, triple

positive or triple negative breast cancer

You cannot participate in this study if you

  • Are physically or mentally incapable to give verbal or written consent
  • For cancer patients: have other active cancers expect for cured skin and in situ cervical cancer
  • For non-cancer participants: history of cancer diagnosis or prior exposure to chemotherapy

agents

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.

Privacy Policy

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? An Institutional Review Board (IRB) is a committee made up of scientists and nonscientists. The IRB’s role is to protect the rights and welfare of human subjects involved in research. The IRB also assures that the research complies with applicable regulations, laws, and institutional policies. UCI