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NCT00610415 Clinical Trial

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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00610415
Other study ID # ENT0023
Secondary ID 98543SU-12142007
Status Completed
Phase N/A
First received January 25, 2008
Last updated June 29, 2016
Start date December 2007

Study information
Verified date June 2016
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• tumor biopsy

Locations
Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quantification of the cancer stem cell population by flow cytometry 1 month No
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