Prospective Collection of Surplus Surgical Tumor Tissues and Pre-surgical Blood Samples (GBCPRT0008)
|Study Design:||Time Perspective: Prospective|
|Official Title:||Prospective Collection of Surplus Surgical Tumor Tissues and Pre-surgical Blood Samples|
- Tumor genetic sequence variation [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]The specimens collected for this project will support genomic studies on the molecular basis of cancer. This study aims to collect specimens for a project that will systematically explore a spectrum of genomic changes involved in human cancer. Specifically the project will analyze DNA copy number changes, including large (on the order of chromosomal segments) and small (1,000 to 100,000 KB) scale rearrangements, transcription profiles, epigenetic modifications, sequence variation, and sequence in both tumor tissue and case-matched germline DNA. The suite of analysis platforms for collaborating laboratories will be applied to a common set of molecular analytes obtained from clinically annotated high-quality tumor specimens and case matched normal control specimens obtained form this specimen collection study. Initial measures critical to ensure specimen quality and qualification for subsequent analysis include confirmed histopathology and RNA integrity.
- Transcription profile [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
- Epigenetic modification [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Surplus Surgical Tissues
Tissue procurement will involve the collection of tissues snap frozen in liquid nitrogen. Tissues will include tumors and histologically normal (uninvolved) areas (>2cm from tumor) of tissue. A tumor tissue sample is required; a normal tissue sample should be provided if available.
Individual samples will be collected in weights (sizes) approximately 100-200 mg or larger. Research tissues sample collection will only be performed on surplus (discard) tissues not required for patient diagnosis and will never interfere with clinical diagnosis.
Blood samples will be collected from consented subjects prior to surgery and will involve the collection of up to 20 ml of whole blood into appropriate blood collection tubes and freezing them.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01792882
|United States, Washington|
|Seattle, Washington, United States, 98104|
|Study Director:||Neil R Mucci||Global BioClinical|