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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Global BioClinical
ClinicalTrials.gov Identifier:
NCT01792882
First received: February 6, 2013
Last updated: August 12, 2014
Last verified: July 2014
  Purpose

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
Breast Cancer
Colorectal Cancer
Lung Cancer
Prostate Cancer
Hematologic Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Collection of Surplus Surgical Tumor Tissues and Pre-surgical Blood Samples

Resource links provided by NLM:


Further study details as provided by Global BioClinical:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Transcription profile [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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

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.


Enrollment: 100
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)
Groups/Cohorts
Cancer Subjects

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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

Criteria

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

CANCER INDICATIONS:

  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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01792882

Locations
United States, Washington
GBC
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Global BioClinical
Investigators
Study Director: Neil R Mucci Global BioClinical
  More Information

No publications provided

Responsible Party: Global BioClinical
ClinicalTrials.gov Identifier: NCT01792882     History of Changes
Other Study ID Numbers: GBC PRT0008
Study First Received: February 6, 2013
Last Updated: August 12, 2014
Health Authority: USA: Western Institutional Review Board (WIRB)

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Hematologic Neoplasms
Prostatic Neoplasms
Breast Diseases
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Hematologic Diseases
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Prostatic Diseases
Rectal Diseases
Skin Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 29, 2014