Unspecified Adult Solid Tumor, Protocol SpecificNCT00900471
Collection and Storage of Tissue Samples From Patients Undergoing Surgery For Suspected Solid Tumors
An observational study of Unspecified Adult Solid Tumor, Protocol Specific and Unspecified Childhood Solid Tumor, Protocol Specific, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- biologic sample preservation procedure and medical chart review
- How many people
- 20,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2004to May 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Those with a clinically suspected solid tumor and scheduled for surgical resection and/or biopsy
Who may be able to join
- Signed protocol specific informed consent prior to registration/randomization.
- Clinically suspected solid tumor AND scheduled for surgical resection and/or biopsy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Study Coordinator contact
United States1 site, 1 recruiting
- Recruiting
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
Clinical Trials Office - Wake Forest University Comprehensive, 336-713-6771
About this study
Official title: 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.
Read the 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
- Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
- Being tested
- biologic sample preservation procedure, medical chart review
- Keywords
- unspecified adult solid tumor, protocol specific, unspecified childhood solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biologic sample preservation procedureOther
medical chart reviewOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue and cell repository for Wake Forest University Comprehensive Cancer Center investigators
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study start1 Apr 2004
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 20,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Edward A. Levine, MD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900471
- Sponsor's protocol ID
- BG04-104
- Other IDs
- P30CA012197, CCCWFU-01403, CCCWFU 01403
- Status last verified
- Mar 2026
- First submitted
- 9 May 2009
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No