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Prospective Collection of Surplus Surgical Tumor Tissues and Pre-surgical Blood Samples (GBCPRT0008)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01792882
Recruitment Status : Enrolling by invitation
First Posted : February 15, 2013
Last Update Posted : July 30, 2019
Information provided by (Responsible Party):
Global BioClinical

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.

Condition or disease
Breast Cancer Colorectal Cancer Lung Cancer Prostate Cancer Hematologic Cancer

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Prospective Collection of Surplus Surgical Tumor Tissues and Pre-surgical Blood Samples
Study Start Date : February 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Cancer Subjects

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Transcription profile [ Time Frame: up to 18 months ]

Other Outcome Measures:
  1. Epigenetic modification [ Time Frame: up to 18 months ]

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects diagnosed with one of the cancer indications listed below and scheduled to undergo surgical tumor resection

Inclusion Criteria:

  • 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

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


  1. Bladder Cancer - Urothelial carcinoma - nonpapillary
  2. Bladder Cancer - Urothelial carcinoma - papillary
  3. Brain Cancer - Astrocytoma
  4. Brain Cancer - Glioblastoma
  5. Brain Cancer - Medulloblastoma
  6. Breast Cancer - Ductal Carcinoma
  7. Breast Cancer - Lobular Carcinoma
  8. Cervical Cancer - Squamous Cell Carcinoma
  9. Colorectal Cancer - Adenocarcinoma
  10. Esophageal Cancer - Adenocarcinoma
  11. Gastric Cancer
  12. Head and Neck Cancer - Squamous Cell Carcinoma
  13. Hematologic Cancer - Acute Lymphocytic Leukemia (ALL)
  14. Hematologic Cancer - Acute Myeloid Leukemia (AML)
  15. Hematologic Cancer - Chronic Lymphocytic Leukemia (CLL)
  16. Hematologic Cancer - Diffuse Large B‐cell Lymphoma
  17. Hematologic Cancer - Multiple Myeloma (MM)
  18. Hematologic Cancer - Non‐Hodgkins Lymphoma (NHL)
  19. Kidney Cancer - Papillary Carcinoma
  20. Kidney Cancer - Renal cell Carcinoma
  21. Liver Cancer - Hepatocellular Carcinoma
  22. Lung Cancer - Adenocarcinoma
  23. Lung Cancer - Squamous Cell Cancer
  24. Melanoma
  25. Pancreatic Cancer - Ductal Adenocarcinoma
  26. Prostate Cancer - Adenocarcinoma
  27. Sarcomas
  28. Thyroid Cancer - Follicular Carcinoma
  29. Thyroid Cancer - Papillary Carcinoma
  30. Uterine Cancer - Endometrial Carcinoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01792882

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United States, Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Global BioClinical
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Study Director: Neil R Mucci Global BioClinical

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Responsible Party: Global BioClinical Identifier: NCT01792882    
Other Study ID Numbers: GBC PRT0008
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases