Collection and Storage of Tissue Samples From Patients Un... | NCT00900471

ID	Type	Description	Link
P30CA012197	U.S. NIH Grant/Contract		View source
CCCWFU-01403
CCCWFU 01403	Other Identifier	WFCCC

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2004Actual

Primary Completion Date

May 2027Estimated

Completion Date

May 2027Estimated

First Submitted Date

May 9, 2009

First Submission Date that Met QC Criteria

May 9, 2009

First Posted Date

May 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2026

Last Update Posted Date

Mar 19, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Wake Forest University Health SciencesOTHER

Collaborators

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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).

Conditions Module

Conditions

Unspecified Adult Solid Tumor, Protocol Specific
Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific
unspecified childhood solid tumor, protocol specific

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
biologic sample preservation procedure	Other
medical chart review	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tissue and cell repository for Wake Forest University Comprehensive Cancer Center investigators		Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed protocol specific informed consent prior to registration/randomization.
Clinically suspected solid tumor AND scheduled for surgical resection and/or biopsy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Study Coordinator	Contact			Sarah.Davis@advocatehealth.org

Overall Officials

Name	Affiliation	Role
Edward A. Levine, MD	Wake Forest University Health Sciences	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wake Forest University Comprehensive Cancer Center	Recruiting	Winston-Salem	North Carolina	27157-1096	United States

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.