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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Head and Neck Cancers
• Intervention / Treatment: Procedure: tumor biopsy

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Eligible patients will have a diagnosis of squamous cell carcinoma

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quantification of the cancer stem cell population by flow cytometry	1 month

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: January 25, 2008
• First Submitted That Met QC Criteria: January 25, 2008
• First Posted (Estimate): February 8, 2008

Study Record Updates

• Last Update Posted (Estimate): July 1, 2016
• Last Update Submitted That Met QC Criteria: June 29, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: ENT0023; 10514 (Other Identifier: Stanford IRB); 98543 (Other Identifier: Stanford University Alternate IRB Approval Number); SU-12142007-934 (Other Identifier: Stanford University); NCT00610415