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.
IU Health Ball Memorial Hospital
- IU Health Ball Memorial Hospital
Indiana University (IU)
- Indiana University Hospital / IU Simon Cancer Center