Head and Neck CancerNCT00898300
Collecting and Storing Tissue Samples From Patients With Head and Neck Cancer
An observational study of Head and Neck Cancer, run by Radiation Therapy Oncology Group at 98 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- biologic sample preservation procedure and biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 351 participants
- Where
- 98 sitesin 2 countries
- Study dates
- Sep 2005to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with confirmed or suspected head and neck cancer
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
Trial locations and contacts
98 sites in 2 countries.
98 sites in 2 countries
United States97 sites
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, 49221
Winship Cancer Institute of Emory University
Altanta, Georgia, 30322
American Fork Hospital
American Fork, Utah, 84003
Saint John's Cancer Center at Saint John's Medical Center
Anderson, Indiana, 46016
AnMed Cancer Center
Anderson, South Carolina, 29621
Georgia Cancer Center for Excellence at Grady Memorial Hospital
Atlanta, Georgia, 30303
Emory Crawford Long Hospital
Atlanta, Georgia, 30308
UAB Comprehensive Cancer Center
Birmingham, Alabama, 35294
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, 83712
Boston University Cancer Research Center
Boston, Massachusetts, 02118
Wood County Oncology Center
Bowling Green, Ohio, 43402
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Sandra L. Maxwell Cancer Center
Cedar City, Utah, 84720
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, 28233-3549
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, 60612-3785
Rush University Medical Center
Chicago, Illinois, 60612
North Coast Cancer Care - Clyde
Clyde, Ohio, 43410
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, 80933
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515-1500
Hematology Oncology Center
Elyria, Ohio, 44035
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, 22401
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534
Wayne Radiation Oncology
Goldsboro, North Carolina, 27534
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, 60426
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009
St. Vincent Oncology Center
Indianapolis, Indiana, 46260
Borgess Medical Center
Kalamazoo, Michigan, 49001
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
Truman Medical Center - Hospital Hill
Kansas City, Missouri, 64108
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City, Missouri, 64111
St. Joseph Medical Center
Kansas City, Missouri, 64114
North Kansas City Hospital
Kansas City, Missouri, 64116
Parvin Radiation Oncology
Kansas City, Missouri, 64116
CCOP - Kansas City
Kansas City, Missouri, 64131
Research Medical Center
Kansas City, Missouri, 64132
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, 68848-1990
Kingsbury Center for Cancer Care at Cheshire Medical Center
Keene, New Hampshire, 03431
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville, Michigan, 48144
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0002
Lima Memorial Hospital
Lima, Ohio, 45804
Monmouth Medical Center
Long Branch, New Jersey, 07740-6395
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40292
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
Northwest Ohio Oncology Center
Maumee, Ohio, 43537-1839
St. Luke's Hospital
Maumee, Ohio, 43537
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226
Providence Milwaukie Hospital
Milwaukie, Oregon, 97222
Community Cancer Center of Monroe
Monroe, Michigan, 48162
Mercy Memorial Hospital - Monroe
Monroe, Michigan, 48162
Cancer Center at Ball Memorial Hospital
Muncie, Indiana, 47303-3499
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, 84157
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
Beth Israel Medical Center - Petrie Division
New York, New York, 10003-3803
Fisher-Titus Medical Center
Norwalk, Ohio, 44857
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden, Utah, 84403
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, 73104
Methodist Estabrook Cancer Center
Omaha, Nebraska, 68114
St. Charles Mercy Hospital
Oregon, Ohio, 43616
Toledo Clinic - Oregon
Oregon, Ohio, 43616
M.D. Anderson Cancer Center at Orlando
Orlando, Florida, 32806
Menorah Medical Center
Overland Park, Kansas, 66209
Advocate Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068-1174
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, 97213-2967
Adventist Medical Center
Portland, Oregon, 97216
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97239
Utah Valley Regional Medical Center - Provo
Provo, Utah, 84604
Renown Institute for Cancer at Renown Regional Medical Center
Reno, Nevada, 89502
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Rutherford Hospital
Rutherfordton, North Carolina, 28139
University of California Davis Cancer Center
Sacramento, California, 95817
Norris Cotton Cancer Center - North
Saint Johnsbury, Vermont, 05819
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506
LDS Hospital
Salt Lake City, Utah, 84103
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, 84106
North Coast Cancer Care, Incorporated
Sandusky, Ohio, 44870
Shawnee Mission Medical Center
Shawnee Mission, Kansas, 66204
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
Cancer Institute at St. John's Hospital
Springfield, Illinois, 62702
Dixie Regional Medical Center - East Campus
St. George, Utah, 84770
Flower Hospital Cancer Center
Sylvania, Ohio, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, 44883
Toledo Hospital
Toledo, Ohio, 43606
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608
Medical University of Ohio Cancer Center
Toledo, Ohio, 43614
CCOP - Toledo Community Hospital
Toledo, Ohio, 43617
St. Anne Mercy Hospital
Toledo, Ohio, 43623
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, 43623
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, 98668
Fulton County Health Center
Wauseon, Ohio, 43567
Canada1 site
McGill Cancer Centre at McGill University
Montreal, Quebec, H2W 1S6
About this study
Official title: 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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- biologic sample preservation procedure, biopsy
- Keywords
- 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
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Esthesioneuroblastoma, Olfactory, Salivary Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biologic sample preservation procedureOther
biopsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients with confirmed or suspected head and neck cancer | Not described Receives: Other: biologic sample preservation procedure; Procedure: biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of a Head and Neck Cancer Tissue/Specimen Bank
Measured: From the start of enrollment to the end of enrollment; enrollment closed at 351 patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startSep 2005
- Primary completionJul 2010
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiation Therapy Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Randal S. Weber, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898300
- Sponsor's protocol ID
- RTOG 0514
- Other IDs
- CDR0000460036
- Status last verified
- Nov 2015
- First submitted
- 9 May 2009
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Head and Neck Cancer Tissue/Specimen Bank
- ClinicalTrials.gov ID
- NCT00898300
- Acronym / sponsor ID
- RTOG 0514
- Conditions
- Head and Neck Cancer
- Keywords
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Radiation Therapy Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2005
- Primary completion
- Jul 2010 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with confirmed or suspected head and neck cancer | – | Other: biologic sample preservation procedure, Procedure: biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmed or suspected head and neck cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biologic sample preservation procedure | Other | Patients with confirmed or suspected head and neck cancer |
| biopsy | Procedure or surgery | Patients with confirmed or suspected head and neck cancer |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randal S. Weber, MD study chair
M.D. Anderson Cancer Center
98 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Radiation Therapy Oncology Group at 98 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 98 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2015.