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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00898300
First received: May 9, 2009
Last updated: July 21, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention
Head and Neck Cancer
Other: biologic sample preservation procedure
Procedure: biopsy

Study Type: Observational
Official Title: Establishment of a Head and Neck Cancer Tissue/Specimen Bank

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Study Start Date: September 2005
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898300

  Show 98 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Randal S. Weber, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00898300     History of Changes
Other Study ID Numbers: CDR0000460036, RTOG-0514
Study First Received: May 9, 2009
Last Updated: July 21, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
stage I squamous cell carcinoma of the larynx
stage II squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage I verrucous carcinoma of the larynx
stage II verrucous carcinoma of the larynx
stage III verrucous carcinoma of the larynx
stage IV verrucous carcinoma of the larynx
stage I basal cell carcinoma of the lip
stage II basal cell carcinoma of the lip
stage III basal cell carcinoma of the lip
stage IV basal cell carcinoma of the lip
stage I mucoepidermoid carcinoma of the oral cavity
stage II mucoepidermoid carcinoma of the oral cavity
stage III mucoepidermoid carcinoma of the oral cavity
stage IV mucoepidermoid carcinoma of the oral cavity
stage I verrucous carcinoma of the oral cavity
stage II verrucous carcinoma of the oral cavity
stage III verrucous carcinoma of the oral cavity
stage IV verrucous carcinoma of the oral cavity
stage I adenoid cystic carcinoma of the oral cavity
stage II adenoid cystic carcinoma of the oral cavity
stage III adenoid cystic carcinoma of the oral cavity
stage IV adenoid cystic carcinoma of the oral cavity
stage I squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the lip and oral cavity

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

ClinicalTrials.gov processed this record on May 19, 2013