- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00900471
Collection and Storage of Tissue Samples From Patients Undergoing Surgery For Suspected Solid Tumors
Advanced Tumor Bank Project
RATIONALE: Collecting and storing samples of tissue or blood from patients with cancer for study in the laboratory may help the study of cancer in the future
PURPOSE: This research study is collecting and storing blood and tissue samples from patients with suspected solid tumors.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- To provide a tissue and cell repository to be used by Wake Forest University Comprehensive Cancer Center (WFUCCC) investigators.
- To provide specialized research pathology services to these investigators.
OUTLINE: Tumor and normal tissue in the resected specimen (when possible) are harvested and collected from patients undergoing planned surgery or biopsy. Additionally, any normal tissue and/or fluid removed in the course of the operation (e.g., cerebrospinal fluid during brain tumor resection) may also be stored for use in analyzing changes from normal tissue to cancerous tissue. Specimens are rapidly frozen in liquid nitrogen to preserve the mRNA, proteins, lipids, and DNA in the samples for future analysis. Tissue is stored for research projects on tumors and treatment of cancer patients. Research may involve analysis of the genetic makeup of the tumor tissue. Genes may be cloned and living cells cultured from the stored tissue. Blood is also collected during surgery. Samples are maintained and cataloged for future retrieval.
Information about medical history is collected from patient medical records. This information includes the following: medical diagnosis; specific information about treatment; other medical conditions; medical data (i.e., laboratory test results, tumor measurements, CT scans, MRI scans, x-rays, and pathology results); side effects experienced and treatment for side effects; long-term information about general health status and the status of disease; data that may be related to tissue and/or blood samples collected; and identifying numbers or codes (i.e., social security number and medical record number).
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
North Carolina
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Winston-Salem, North Carolina, United States, 27157-1096
- Recruiting
- Wake Forest University Comprehensive Cancer Center
-
Contact:
- Clinical Trials Office - Wake Forest University Comprehensive
- Phone Number: 336-713-6771
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Clinically suspected solid tumor AND scheduled for surgical resection and/or biopsy
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tissue and cell repository for Wake Forest University Comprehensive Cancer Center investigators
Time Frame: Day 1
|
Day 1
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Edward A. Levine, MD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BG04-104
- P30CA012197 (U.S. NIH Grant/Contract)
- CCCWFU-01403
- CCCWFU 01403 (Other Identifier: WFCCC)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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