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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00898300
First received: May 9, 2009
Last updated: November 22, 2013
Last verified: November 2013

May 9, 2009
November 22, 2013
September 2005
July 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
  • Establishment of a head and neck cancer tissue/specimen bank [ Designated as safety issue: No ]
  • Establishment of a database of patients participating in Radiation Therapy Oncology Group clinical trials [ Designated as safety issue: No ]
  • Resource for testing emerging scientific questions or assays [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00898300 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Collecting and Storing Tissue Samples From Patients With Head and Neck Cancer
Establishment of a Head and Neck Cancer Tissue/Specimen Bank

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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.

Non-Probability Sample

Patients with confirmed or suspected head and neck cancer

Head and Neck Cancer
  • Other: biologic sample preservation procedure
  • Procedure: biopsy
Patients with confirmed or suspected head and neck cancer
Interventions:
  • Other: biologic sample preservation procedure
  • Procedure: biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
351
November 2013
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00898300
RTOG 0514, CDR0000460036
No
Radiation Therapy Oncology Group
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Study Chair: Randal S. Weber, MD M.D. Anderson Cancer Center
Radiation Therapy Oncology Group
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP