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
  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
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Establishment of a Head and Neck Cancer Tissue/Specimen Bank

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

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.


Enrollment: 351
Study Start Date: September 2005
Study Completion Date: November 2013
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with confirmed or suspected head and neck cancer Other: biologic sample preservation procedure Procedure: biopsy

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
Sampling Method:   Non-Probability Sample
Study Population

Patients with confirmed or suspected head and neck cancer

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00898300     History of Changes
Other Study ID Numbers: RTOG 0514, CDR0000460036
Study First Received: May 9, 2009
Last Updated: November 22, 2013
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
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 August 19, 2014