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

This study has been completed.
Information provided by (Responsible Party):
Stanford University Identifier:
First received: January 25, 2008
Last updated: June 29, 2016
Last verified: June 2016
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 Intervention
Head and Neck Cancer
Head and Neck Cancers
Procedure: tumor biopsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biopsy of Human Tumors for Cancer Stem Cell Characterization: a Feasibility Study

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Quantification of the cancer stem cell population by flow cytometry [ Time Frame: 1 month ]

Biospecimen Retention:   Samples With DNA
Tissue samples

Enrollment: 40
Study Start Date: December 2007
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible patients will have a diagnosis of squamous cell carcinoma

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
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Please refer to this study by its identifier: NCT00610415

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Dr. A. Dimitrios Colevas Stanford University
  More Information

Responsible Party: Stanford University Identifier: NCT00610415     History of Changes
Other Study ID Numbers: ENT0023
98543 ( Other Identifier: Stanford University Alternate IRB Approval Number )
SU-12142007-934 ( Other Identifier: Stanford University )
10514 ( Other Identifier: Stanford IRB )
Study First Received: January 25, 2008
Last Updated: June 29, 2016

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms processed this record on May 25, 2017