Development of a Tumor Molecular Analyses Program and Its Use to Support Treatment Decisions
This study is currently recruiting participants.
Verified April 2012 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01457196
First received: October 13, 2011
Last updated: April 20, 2012
Last verified: April 2012
Tracking Information | |||||
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First Received Date ICMJE | October 13, 2011 | ||||
Last Updated Date | April 20, 2012 | ||||
Start Date ICMJE | September 2011 | ||||
Estimated Primary Completion Date | September 2015 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Number and type of genetic mutations found in each patient's tumor sample [ Time Frame: 1 year ] [ Designated as safety issue: No ] We will describe the number of patients enrolled, and the number and type of genetic mutations discovered. |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01457196 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Development of a Tumor Molecular Analyses Program and Its Use to Support Treatment Decisions | ||||
Official Title ICMJE | Development of a Tumor Molecular Analyses Program and Its Use to Support Treatment Decisions | ||||
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. |
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Detailed Description | |||||
Study Type ICMJE | Observational | ||||
Study Design ICMJE | Time Perspective: Prospective | ||||
Biospecimen | Retention: Samples With DNA Description: Tumor tissue, normal adjacent tissue, blood, cheek (buccal) swab |
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Sampling Method | Non-Probability Sample | ||||
Study Population | Cancer patients seen at the UNC Cancer Hospital and its clinics |
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Condition ICMJE | Neoplasm | ||||
Intervention ICMJE | |||||
Study Group/Cohort (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 400 | ||||
Estimated Completion Date | September 2016 | ||||
Estimated Primary Completion Date | September 2015 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | |||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01457196 | ||||
Other Study ID Numbers ICMJE | LCCC1108 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | UNC Lineberger Comprehensive Cancer Center | ||||
Study Sponsor ICMJE | UNC Lineberger Comprehensive Cancer Center | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | UNC Lineberger Comprehensive Cancer Center | ||||
Verification Date | April 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |