Biopsy of Human Tumors for Cancer Stem Cell Characterization: a Feasibility Study

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00610415
• Collaborator: (none)
• Enrollment: 40
• Location: 1

Study Details

Study Description

Brief Summary

To see if a limited sampling of tumor tissue from human subjects is a feasible way to gather adequate tissue for cancer stem cell quantification.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer; Head and Neck Cancers	Procedure: tumor biopsy

Study Design

• Study Type: Observational
• Actual Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Biopsy of Human Tumors for Cancer Stem Cell Characterization: a Feasibility Study
• Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: Oct 1, 2012

Outcome Measures

Primary Outcome Measures

1. Quantification of the cancer stem cell population by flow cytometry [1 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:1. Patients with malignant tumors seen at the Stanford University Cancer Center. Eligible patients will have a diagnosis of squamous cell carcinoma (HNSCC) and will have been seen in the Stanford Head and Neck Oncology Program. A decision to undergo surgery at Stanford will have been made, prior to recruiting patients for the study, and prior to obtaining the samples during surgery. (Histological confirmation of the diagnosis need not be made prior to obtaining consent.) 2. A definitive resection of a malignant tumor is planned. 3. Surgeon judgment that the definitive procedure will not be compromised by including

• FNA

• Core needle biopsy

• Cup forceps or punch biopsy of<4mm. 4. Informed consent documented prior to procedure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Dr. A. Dimitrios Colevas, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT00610415
• Other Study ID Numbers: ENT0023; 98543; SU-12142007-934; 10514
• First Posted: Feb 8, 2008
• Last Update Posted: Jul 1, 2016
• Last Verified: Jun 1, 2016

• Additional relevant MeSH terms: Head and Neck Neoplasms

Study Results

No Results Posted as of Jul 1, 2016