Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01457196
Recruitment Status : Completed
First Posted : October 21, 2011
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Neoplasm Diagnostic Test: Tumor Genetic Sequencing Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2798 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Development of a Tumor Molecular Analyses Program and Its Use to Support Treatment Decisions
Study Start Date : September 2011
Actual Primary Completion Date : June 6, 2018
Actual Study Completion Date : June 6, 2018

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Number and type of genetic mutations found in each patient's tumor sample [ Time Frame: 1 year ]
    To estimate the proportion of patients enrolled on the study who have undergone successful sequencing and have a reportable genetic variant identified

  2. Progression Free Survival [ Time Frame: 1 Year ]
    Compare the progression free survival ratios between cancer patients with active disease with a reportable genetic variant and those without a reportable genetic variant


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 1 Year ]
    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

  2. Collect and describe clinical data [ Time Frame: 1 Year ]
    To collect and describe clinical data including treatment outcomes after availability of results in patients



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01457196


Locations
Layout table for location information
United States, North Carolina
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: H. Shelton Earp, MD University of North Carolina, Chapel Hill

Layout table for additonal information
Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01457196     History of Changes
Other Study ID Numbers: LCCC1108
First Posted: October 21, 2011    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: March 2019
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Cancer Genetics