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Development of a Tumor Molecular Analyses Program and Its Use to Support Treatment Decisions

18 Years
Open (Enrolling)

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Trial Information

Development of a Tumor Molecular Analyses Program and Its Use to Support Treatment Decisions

Inclusion Criteria:

1. Current or prospective cancer patients; current cancer patients must have
histologically or cytologically confirmed diagnosis of cancer

2. Tumor tissue available and suitable for molecular analyses from at least one of the
following sources:

- Tissue previously stored in UNC's Tissue Procurement Facility (TPF)

- Patient undergoing tissue collection as per clinical standard of care and
willing to have additional specimens taken for research

- Patient willing to undergo biopsy for purpose of research only

3. The following inclusion criteria apply only to patients undergoing biopsy for
research purposes only under this protocol:

- ≥18 years of age

- Treatment options offer no expectation of cure, e.g., advanced solid tumor
patients with metastatic disease. NOTE: This restriction applies to biopsy of
vital organs only, e.g., lung, liver, etc.

- Appropriate candidate for research biopsy based on institutional standards for
target biopsy site

Exclusion Criteria:

1. Dementia, altered mental status, or any psychiatric condition or co-morbid condition
that would prohibit the understanding or rendering of informed consent.

2. The following exclusion criteria apply only to enrolled patients undergoing biopsy
for research purposes only:

3. History of serious or life-threatening allergic reaction to local anesthetics (i.e.
lidocaine, xylocaine) or any medications used for conscious sedation (if applicable).

4. Pregnant or lactating women

5. Active cardiac disease

6. Patients receiving bevacizumab less than 6 weeks prior to enrollment into this study
should not undergo research core biopsies because of the concern for potential
increased bleeding risk and delayed healing. (NOTE: Patients receiving bevacizumab
who are undergoing a research biopsy of accessible organs (e.g. breast, lymph node,
skin etc.) must be two weeks from the last dose of the angiogenesis inhibitor).

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

Number and type of genetic mutations found in each patient's tumor sample

Outcome Description:

We will describe the number of patients enrolled, and the number and type of genetic mutations discovered.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

H. Shelton Earp, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina, Chapel Hill


United States: Institutional Review Board

Study ID:




Start Date:

September 2011

Completion Date:

September 2016

Related Keywords:

  • Neoplasm
  • Cancer Genetics
  • Neoplasms



University of North Carolina Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina  27599