Prospective Collection of Surplus Surgical Tumor Tissues and Pre-surgical Blood Samples

NCT01792882 | Withdrawn

• 1 other identifier: GBC PRT0008
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Colorectal Cancer; Lung Cancer; Prostate Cancer; Hematologic Cancer

Outcome Measures

Primary Outcomes (1)

• Tumor genetic sequence variation

  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.

  up to 18 months

Secondary Outcomes (1)

• Transcription profile

  up to 18 months

Other Outcomes (1)

• Epigenetic modification

  up to 18 months

Study Arms (1)

Cancer Subjects

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects diagnosed with one of the cancer indications listed below and scheduled to undergo surgical tumor resection

You may qualify if:

• Any adult age
• Any sex
• 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

You may not qualify if:

• 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
• Breast Cancer - Ductal Carcinoma
• Breast Cancer - Lobular Carcinoma
• Cervical Cancer - Squamous Cell Carcinoma
• Colorectal Cancer - Adenocarcinoma
• Esophageal Cancer - Adenocarcinoma

Sponsors & Collaborators

• Global BioClinical: lead

Study Sites (1)

GBC

Seattle, Washington, 98104, United States

Location

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 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.

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Lung Neoplasms; Prostatic Neoplasms; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Neil R Mucci

  Global BioClinical

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 15, 2013
• Study Start: February 1, 2013
• Primary Completion: December 31, 2022
• Study Completion: February 27, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

US (1)