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

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ClinicalTrials.gov Identifier: NCT00610415
Recruitment Status : Completed
First Posted : February 8, 2008
Last Update Posted : July 1, 2016
Sponsor:
Information provided by (Responsible Party):
Stanford University

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
Head and Neck Cancer Head and Neck Cancers Procedure: tumor biopsy

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 : December 2007
Actual Primary Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources




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

Biospecimen Retention:   Samples With DNA
Tissue samples


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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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00610415


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

Responsible Party: Stanford University
ClinicalTrials.gov 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 )
First Posted: February 8, 2008    Key Record Dates
Last Update Posted: July 1, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms