Prospective Collection of Surplus Surgical Tumor Tissues and Pre-surgical Blood Samples (GBC PRT0008)
The study is intended to collect specimens to support the application of genome analysis technologies, including large-scale genome sequencing. This study will ultimately provide cancer researchers with specimens that they can use to develop comprehensive catalogs of genomic information on at least 50 types of human cancer. The study will create a resource available to the worldwide research community that could be used to identify and accelerate the development of new diagnostic and prognostic markers, new targets for pharmaceutical interventions, and new cancer prevention and treatment strategies. This study will be a competitive enrollment study conducted at multiple institutions.
|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 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
This study will enroll subjects diagnosed with various cancers and who are scheduled to undergo surgical treatment. Prior to scheduled surgery, subjects will be asked to donate a 10-20 ml blood sample. After surgery, surplus tissues (including tumor and adjacent normal tissues) not required for diagnosis will be collected. Subject clinical information will be collected, including basic demographic information, medical history, family history, current cancer history and treatment. After surgery, a final pathology report will be obtained for each subject's surgical specimen. In some instances and based on the cancer indications required, longitudinal data may also be collected at a frequency of every 6 months to once per year. Longitudinal data will include information on study subject survival and disease recurrence.
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|