Clinical trial NCT01457196: Development of a Tumor Molecular Analyses Program and Its Use to Support Treatment Decisions
Official title: Development of a Tumor Molecular Analyses Program and Its Use to Support Treatment Decisions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasm
Keywords: Cancer Genetics
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2011-10-21
Enrollment: 2798
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 profiling of alterations with known clinical utility using tumor and germline specimens to support treatment decisions.


Eligibility criteria: 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)
   * 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
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. Any condition that would make participation in the protocol unreasonably hazardous for the patient in the opinion of the treating physician
2. Dementia, altered mental status, or any psychiatric condition or co-morbid condition that would prohibit the understanding or rendering of informed consent.
3. The following exclusion criteria apply only to enrolled patients undergoing biopsy for research purposes only:
4. History of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine) or any medications used for conscious sedation (if applicable).
5. Requires general anesthesia for collection of biopsy
6. Pregnant or lactating women
7. Active cardiac disease
8. 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).

Primary outcomes:
measure: Proportion of Patients With a Reportable Genetic Variant
timeFrame: 1 year
measure: Progression Free Survival
timeFrame: 2 Year
Secondary outcomes:
Other outcomes:
measure: Collect and Describe Clinical Data
timeFrame: 1 Year
measure: Progression Free Survival
timeFrame: 1 Year
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: H. Shelton Earp, MD
role: PRINCIPAL_INVESTIGATOR
References: