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

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.

Study Overview

• Status: Completed
• Conditions: Neoplasm
• Intervention / Treatment: Diagnostic test: Tumor Genetic Sequencing

• Study Type: Interventional
• Enrollment (Actual): 2798
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Sequencing Arm	Diagnostic test: Tumor Genetic Sequencing; This study will look at genetic material from a sample of the subjects tumor, look at certain changes in the genetic material, and see if these changes are related to the subjects cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients With a Reportable Genetic Variant	To estimate the proportion of patients enrolled on the study who have undergone successful sequencing and have a reportable genetic variant identified	1 year
Progression Free Survival	Estimate Progression Free Survival (PFS) at 2 years in cancer patients with active disease with a reportable genetic variant and those without a reportable genetic variant	2 Year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collect and Describe Clinical Data	To collect and describe clinical data including treatment outcomes after availability of results in patients	1 Year
Progression Free Survival	To compare progression free survival ratios between cancer patients with active disease with reportable genetic variant who were treated based on variant and those who were not treated based on a variant	1 Year

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: Principal Investigator: H. Shelton Earp, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): June 6, 2018
• Study Completion (Actual): June 6, 2018

Study Registration Dates

• First Submitted: October 13, 2011
• First Submitted That Met QC Criteria: October 20, 2011
• First Posted (Estimate): October 21, 2011

Study Record Updates

• Last Update Posted (Actual): December 30, 2019
• Last Update Submitted That Met QC Criteria: December 12, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Cancer Genetics
• Other Study ID Numbers: LCCC1108