Collection and Storage of Tissue Samples From Patients Undergoing Surgery For Suspected Solid Tumors

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT00900471
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 20,000
• Location: 1
• Duration (Months): 252
• Patients Per Site Per Month: 79.4

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific	Other: biologic sample preservation procedure; Other: medical chart review

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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 20000 participants
• Observational Model: Case-Only
• Time Perspective: Other
• Official Title: Advanced Tumor Bank Project
• Study Start Date: May 1, 2004
• Anticipated Primary Completion Date: May 1, 2025
• Anticipated Study Completion Date: May 1, 2025

Outcome Measures

Primary Outcome Measures

1. Tissue and cell repository for Wake Forest University Comprehensive Cancer Center investigators [Day 1]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Clinically suspected solid tumor AND scheduled for surgical resection and/or biopsy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina	United States	27157-1096

Sponsors and Collaborators

• Wake Forest University Health Sciences
• National Cancer Institute (NCI)

Investigators

• Study Chair: Edward A. Levine, MD, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT00900471
• Other Study ID Numbers: BG04-104; P30CA012197; CCCWFU-01403; CCCWFU 01403
• First Posted: May 12, 2009
• Last Update Posted: Jun 6, 2022
• Last Verified: Jun 1, 2022

• 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

Study Results

No Results Posted as of Jun 6, 2022