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

February 27, 2023 updated by: Global BioClinical
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 Overview

Status

Withdrawn

Conditions

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • GBC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Cancer Subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Transcription profile
Time Frame: up to 18 months
up to 18 months

Other Outcome Measures

Outcome Measure
Time Frame
Epigenetic modification
Time Frame: up to 18 months
up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Global BioClinical

Investigators

  • Study Director: Neil R Mucci, Global BioClinical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

February 27, 2023

Study Registration Dates

First Submitted

February 6, 2013

First Submitted That Met QC Criteria

February 13, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Estimate)

February 28, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GBC PRT0008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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