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: Recruiting
• Conditions: Unspecified Childhood Solid Tumor, Protocol Specific; Unspecified Adult Solid Tumor, Protocol Specific
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

• Study Contact: Name: Study Coordinator; Email: Sarah.Davis@advocatehealth.org

Study Locations

• United States
  • North Carolina
    • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Those with a clinically suspected solid tumor and scheduled for surgical resection and/or biopsy

Description

Inclusion Criteria:

• Signed protocol specific informed consent prior to registration/randomization.
• 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	Day 1

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Edward A. Levine, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2004
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: May 9, 2009
• First Submitted That Met QC Criteria: May 9, 2009
• First Posted (Estimated): May 12, 2009

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: unspecified childhood solid tumor, protocol specific; unspecified adult solid tumor, protocol specific
• Additional Relevant MeSH Terms: Neoplasms
• 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: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No