Biorepository for Precision Genomics



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/4/2017
Start Date:August 27, 2015
End Date:May 31, 2021
Contact:Patrick Kiel, PharmD
Email:pkiel@iu.edu

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Collection of Specimens and Clinical Data to Create a Biorepository for Precision Genomics

This is a tissue collection protocol to create an annotated biorepository to support future
basic and translational research. The study protocol and consent will request patient
permission to allow their specimens to be stored for future use in other
laboratory/correlative studies without requiring a separate new consent at a future date. It
will include also a retrospective review of all patients who have been seen or treated by the
Precision Genomics Clinic (waiver of consent requested). No specific research studies/aims
are included directly in this proposal. Use of the samples, data, and other resources (cell
lines, etc.) created within this protocol will require review/approval by the majority of the
Precision Genomics Investigators and appropriate IRB approval.


Inclusion Criteria:

1. ≥ 18 years old at the time of informed consent

2. Ability to provide written informed consent and HIPAA authorization

3. Patients must have histologically or cytologically confirmed malignancy or related
disorder. This includes patients with active disease as well as those in remission.

4. One of the following tissue collection situations

- Group 1: Patients having tissue collection for clinical reasons who are willing
to have additional specimens taken for research (biopsy may be done under local
anesthesia, intravenous conscious sedation, or general anesthesia, as clinically
indicated)

- Group 2: Patients willing to undergo tissue collection for the purpose of
research only (biopsy may be done under local anesthesia or intravenous conscious
sedation per the judgment of the treating physician). This may include collection
of additional samples from patients undergoing a study-specific research
biopsy/procedure. Patients in group 2 may not undergo general anesthesia as part
of this protocol.

- Group 3: Patients having tissue collection for clinical reasons who are willing
to have excess tissue (i.e., tissue that would have otherwise been discarded)
banked for research (biopsy may be done under local anesthesia, intravenous
conscious sedation, or general anesthesia, as clinically indicated).

5. Willingness to undergo phlebotomy for research blood samples Additional Criteria for
Patients in Groups 1 and 2

6. PT and PTT levels < 1.2 x the institutional ULN (PT, PTT not required for skin
biopsies)

7. Not receiving therapeutic anticoagulation

8. Platelets ≥ 100 x 109/L

Exclusion Criteria:

1. Concurrent disease or condition that would make the patient inappropriate for study
participation or any serious medical or psychiatric disorder that would interfere with
the subject's safety.

2. Dementia, altered mental status, or any psychiatric condition that would prohibit the
understanding or rendering of informed consent.

3. History of serious or life-threatening allergic reaction to local anesthetics (i.e.
lidocaine, xylocaine)

4. Any other condition, which in the opinion of the patient's treating oncologist or the
physician performing the biopsy procedure, would make participation in this protocol
unreasonably hazardous for the patient.

Additional Criteria for Patients in Group 1 and 2

5. Pregnant women are excluded from Groups 1 and 2 because there may be an increased risk
to both mother and fetus in the setting of conscious sedation, which is required for
biopsies of certain anatomic sites (e.g. liver, lung, bone). Also, ionizing radiation
from CT-guided biopsies may pose a risk to the unborn fetus.

6. Patients in Groups 1 and 2 may not have active cardiac disease, defined as:

- History of uncontrolled or symptomatic angina

- History of arrhythmias requiring medications, or clinically significant

- Myocardial infarction < 6 months from study entry

- Uncontrolled or symptomatic congestive heart failure

- Any other cardiac condition, which in the opinion of the treating physician,
would make this protocol unreasonably hazardous for the patient

7. Patients in group 1 and 2 receiving bevacizumab or other angiogenesis inhibitors (or
less than 6 weeks from last dose of an angiogenesis inhibitor) should not undergo a
research core liver biopsy on this protocol because of the concern for the possibility
of increased bleeding risk. Patients may undergo a research fine needle aspiration
(FNA) of the liver as an alternative. Patients may also undergo core research biopsies
of other sites, up to the discretion of the treating physician, but physicians should
take the potential increased bleeding and/or delayed wound healing issues into
consideration.
We found this trial at
1
site
535 Barnhill Dr
Indianapolis, Indiana 46202
(888) 600-4822
Phone: 317-274-2797
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
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mi
from
Indianapolis, IN
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