Status:
COMPLETED
Development of a Tumor Molecular Analyses Program and Its Use to Support Treatment Decisions
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Conditions:
Neoplasm
Eligibility:
All Genders
Phase:
NA
Brief Summary
The primary objective of this specimen correlative study is two-fold: to provide a mechanism for the association of known molecular alterations with clinical outcomes, and to provide rapid genetic pro...
Eligibility Criteria
Inclusion
- Current or prospective cancer patients; current cancer patients must have histologically or cytologically confirmed diagnosis of cancer
- 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)
- Tissue previous stored at an institution other than UNC-CH, provided investigators can determine that the tumors were sampled and stored under appropriate conditions for inclusion in the study
- Patient undergoing tissue collection as per clinical standard of care and willing to allow specimens from surplus tissue to be diverted for research purposes
- 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
- 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
- Any condition that would make participation in the protocol unreasonably hazardous for the patient in the opinion of the treating physician
- Dementia, altered mental status, or any psychiatric condition or co-morbid condition that would prohibit the understanding or rendering of informed consent.
- The following exclusion criteria apply only to enrolled patients undergoing biopsy for research purposes only:
- History of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine) or any medications used for conscious sedation (if applicable).
- Requires general anesthesia for collection of biopsy
- Pregnant or lactating women
- Active cardiac disease
- 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).
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2018
Estimated Enrollment :
2798 Patients enrolled
Trial Details
Trial ID
NCT01457196
Start Date
September 1 2011
End Date
June 6 2018
Last Update
December 30 2019
Active Locations (1)
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1
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599