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Collection and Storage of Tissue Samples From Patients Undergoing Surgery For Suspected Solid Tumors
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Purpose
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.
| Condition | Intervention |
|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific | Other: biologic sample preservation procedure Other: medical chart review |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Other |
| Official Title: | Advanced Tumor Bank Project |
- Tissue and cell repository for Wake Forest University Comprehensive Cancer Center investigators [ Time Frame: Day 1 ]
| Estimated Enrollment: | 2500 |
| Study Start Date: | May 2004 |
| Estimated Study Completion Date: | May 2020 |
| Estimated Primary Completion Date: | May 2020 (Final data collection date for primary outcome measure) |
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).
Eligibility| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Clinically suspected solid tumor AND scheduled for surgical resection and/or biopsy
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00900471
| United States, North Carolina | |
| Wake Forest University Comprehensive Cancer Center | Recruiting |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771 | |
| Study Chair: | Edward A. Levine, MD | Wake Forest University Health Sciences |
More Information
| Responsible Party: | Wake Forest University Health Sciences |
| ClinicalTrials.gov Identifier: | NCT00900471 History of Changes |
| Other Study ID Numbers: |
CCCWFU 01403 P30CA012197 ( U.S. NIH Grant/Contract ) CCCWFU-01403 CCCWFU-BG04-104 |
| Study First Received: | May 9, 2009 |
| Last Updated: | May 25, 2017 |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Wake Forest University Health Sciences:
|
unspecified adult solid tumor, protocol specific unspecified childhood solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on September 20, 2017