Prospective Collection of Surplus Surgical Tumor Tissues and Pre-surgical Blood Samples
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Global BioClinical
- Locations
- 1
- Primary Endpoint
- Tumor genetic sequence variation
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Any adult age
- •Able to provide consent for surplus tissue and/or blood donation
- •Diagnosed with one of the cancer indications listed below:
- •Scheduled to undergo surgical resection of tumor (exception for hematological cancers)
- •Have not yet received treatment for cancer
Exclusion Criteria
- •Not diagnosed with required cancer indication
- •Not scheduled to undergo surgical resection of the tumor
- •Have already received cancer treatment (such as chemotherapy, radiation, surgery) for the current cancer or a previously diagnosed cancer
- •Not able to donate an adequate volume of blood to meet minimum requirements
- •CANCER INDICATIONS:
- •Bladder Cancer - Urothelial carcinoma - nonpapillary
- •Bladder Cancer - Urothelial carcinoma - papillary
- •Brain Cancer - Astrocytoma
- •Brain Cancer - Glioblastoma
- •Brain Cancer - Medulloblastoma
Outcomes
Primary Outcomes
Tumor genetic sequence variation
Time Frame: up to 18 months
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.
Secondary Outcomes
- Transcription profile(up to 18 months)