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Collecting and Storing Tissue Samples From Patients With Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00898300
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : November 13, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Tracking Information
First Submitted Date May 9, 2009
First Posted Date May 12, 2009
Last Update Posted Date November 13, 2015
Study Start Date September 2005
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 22, 2013)
Establishment of a Head and Neck Cancer Tissue/Specimen Bank [ Time Frame: From the start of enrollment to the end of enrollment; enrollment closed at 351 patients ]
Original Primary Outcome Measures
 (submitted: May 9, 2009)
  • Establishment of a Head and Neck Cancer Tissue/Specimen Bank
  • Establishment of a database of patients participating in Radiation Therapy Oncology Group clinical trials
  • Resource for testing emerging scientific questions or assays
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Collecting and Storing Tissue Samples From Patients With Head and Neck Cancer
Official Title Establishment of a Head and Neck Cancer Tissue/Specimen Bank
Brief Summary

RATIONALE: Collecting and storing samples of tissue, blood, and saliva from patients with cancer to study in the laboratory may help the study of cancer in the future.

PURPOSE: This laboratory study is collecting and storing tissue samples from patients with head and neck cancer.

Detailed Description

OBJECTIVES:

  • Establish a tissue/specimen bank of biologic specimens collected from patients with proven or suspected head and neck cancer.
  • Establish a database to link materials acquisition and pathologic and clinical information on these patients.
  • Correlate clinical-pathological findings on these patients with future scientific studies using the patient database.
  • Test new hypotheses as they emerge.

OUTLINE: This is a prospective, multicenter study.

Patients enrolled on active Radiation Therapy Oncology Group clinical trials undergo biopsy or surgical resection of head and neck tumors or premalignant lesions at participating institutions. Tissue and other specimens collected at the time of biopsy or surgery are submitted to the Head and Neck Cancer Tissue/Specimen Bank which acts as a central repository for processing, storing, and preserving patient specimens for translational research. Tissue samples include paraffin-embedded blocks or fresh or frozen samples of normal squamous mucosa, tumors, or premalignant lesions of the upper aerodigestive tract. Other specimens for tissue banking include serum, plasma, and lymphocytes isolated from peripheral blood, as well as samples of patient saliva. Cells obtained from tissue bank specimens may also be used to establish cell lines for future research.

PROJECTED ACCRUAL: An unlimited number of specimens will be accrued for this study.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
1. Fresh frozen specimens of normal squamous mucosa, tumors, and pre-malignant lesions of the upper aerodigestive tract. 2. Paraffin-embedded tissue sections from head and neck premalignant and malignant lesions. 3. Serum, plasma and isolate lymphocytes from blood drawn from patients with head and neck cancer. 4. Buccal scrapings and saliva samples from patients with head and neck cancer.
Sampling Method Non-Probability Sample
Study Population Patients with confirmed or suspected head and neck cancer
Condition Head and Neck Cancer
Intervention
  • Other: biologic sample preservation procedure
  • Procedure: biopsy
Study Groups/Cohorts Patients with confirmed or suspected head and neck cancer
Interventions:
  • Other: biologic sample preservation procedure
  • Procedure: biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 22, 2013)
351
Original Enrollment Not Provided
Actual Study Completion Date November 2013
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Confirmed or suspected head and neck cancer

    • Primary site recurrence allowed
  • Potentially eligible for or participating in an active Radiation Therapy Oncology Group treatment clinical trial

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Concurrent radiotherapy, drug therapy, biopsy, or surgery allowed
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00898300
Other Study ID Numbers RTOG 0514
CDR0000460036
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Radiation Therapy Oncology Group
Study Sponsor Radiation Therapy Oncology Group
Collaborators National Cancer Institute (NCI)
Investigators
Study Chair: Randal S. Weber, MD M.D. Anderson Cancer Center
PRS Account Radiation Therapy Oncology Group
Verification Date November 2015