Head and Neck CancerNCT00898638
Tissue Sample Collection From Patients With Head and Neck Cancer and From Healthy Participants
An observational study of Head and Neck Cancer, run by Vanderbilt University Medical Center at 4 sites in United States.
Trial summary
RATIONALE: Collecting and storing samples of tissue, saliva, and blood from patients with cancer and from healthy participants to study in the laboratory may help the study of cancer in the future. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- biologic sample preservation procedure and medical chart review
- How many people
- 8,000 participants
- Where
- 4 sitesUnited States
- Study dates
- 13 Feb 2003to Dec 2050
- How long will I take part?
- 9999 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Head and neck tumor patients, aged 18 and older and Healthy volunteers, aged 18 and older.
DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria:
- Diagnosis of head and neck cancer
- Being treated at Vanderbilt University Medical Center for the cancer
- Healthy participant
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37064
Eben Rosenthal, MD, 800-811-8480
- Recruiting
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, 37064
Eben Rosenthal, MD, 800-811-8480
- Recruiting
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, 37212
Clinical Trials Office - Veterans Affairs Medical Center - Nas, 615-327-4751
- Recruiting
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
Clinical Trials Office - Vanderbilt-Ingram Cancer Center, 800-811-8480
About this study
Official title: Head and Neck Tumor Tissue Repository and Clinical Database
RATIONALE: Collecting and storing samples of tissue, saliva, and blood from patients with cancer and from healthy participants to study in the laboratory may help the study of cancer in the future.
PURPOSE: This research study is collecting and storing tissue samples from patients with head and neck cancer and from healthy participants.
Read the detailed description
OBJECTIVES:
- Maintain and update a clinical database pertaining to diagnosis and treatment outcome of patients with head and neck cancer.
- Develop a repository of biospecimens from these patients.
OUTLINE: Tumor tissue samples and/or bronchial washings are collected from patients undergoing planned surgery and/or bronchoscopy, respectively. Buccal swabs and/or mouthwash samples and saliva samples are collected. Patients also undergo blood sample collection at baseline and then every 2-6 months thereafter.
Healthy participants contribute blood samples, buccal swabs, and mouthwash samples at baseline only.
Information about medical and family history and cancer risk factors is also collected.
PROJECTED ACCRUAL: No limit.
FOLLOW UP: Indefinite, until date of death or lost to follow up.
- Conditions
- Head and Neck Cancer
- Being tested
- biologic sample preservation procedure, medical chart review
- 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, recurrent squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage I verrucous carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage II verrucous carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage III verrucous carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage IV verrucous carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, recurrent verrucous carcinoma of the larynx, stage I adenoid cystic carcinoma of the oral cavity, stage I basal cell carcinoma of the lip, stage I mucoepidermoid carcinoma of the oral cavity, stage I squamous cell carcinoma of the lip and oral cavity, stage I verrucous 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
medical chart reviewOther
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Non-tumor volunteers will be asked to participate at the time that they are attending a head and neck cancer screening clinic or at the time they are accompanying a patient to their appointment at the head and neck clinic. Intake sheets and biological specimens contributed by volunteers will be coded at the time of collection so that no identifiers are obtained. These specimens will not be linked to identifiers. Receives: Other: biologic sample preservation procedure; Other: medical chart review | |
| Head and Neck Tumor patients | Eligible patients will be identified at the Vanderbilt Head \& Neck Clinic by clinical and research staff. An appropriately trained staff member will discuss the protocol with the patient (including, risks, benefits, alternatives, etc.). Receives: Other: biologic sample preservation procedure; Other: medical chart review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of a clinical database pertaining to diagnosis and treatment outcome of patients with head and neck cancer
Collection of data for both groups from the Vanderbilt Otolaryngology Patient Intake questionnaire as well as the medical record, such as medical history, family history, and exposures to risk factors for cancer (tobacco and alcohol use), and results of tests related to diagnosis of tumor and treatment response (for tumor patients only).
Measured: ongoing
Development of a repository of biospecimens
Collection of blood, tissue, saliva, bronchial washings and other specimens as indicated from both tumor and healthy patients.
Measured: ongoing
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 start13 Feb 2003
- Primary completionDec 2050 (estimated)
- Study completionDec 2050 (estimated)
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.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 8,000 participants (estimated)
- Target duration
- 9999 Days
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Eben Rosenthal, Vanderbilt University Medical Center
- Investigators
- Eben Rosenthal, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898638
- Sponsor's protocol ID
- CDR0000546682
- Other IDs
- P30CA068485, VU-VICC-HN-0356, VU-VICC-IRB-030062
- Status last verified
- Oct 2025
- First submitted
- 9 May 2009
- Last updated
- 28 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head and Neck Tumor Tissue Repository and Clinical Database
- ClinicalTrials.gov ID
- NCT00898638
- Acronym / sponsor ID
- CDR0000546682
- 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, recurrent squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage I verrucous carcinoma of the larynx, stage II squamous cell carcinoma of the larynx
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Feb 2003 (actual)
- Primary completion
- Dec 2050 (estimated)
- Study completion
- Dec 2050 (estimated)
- 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, saliva, and blood from patients with cancer and from healthy participants to study in the laboratory may help the study of cancer in the future.
PURPOSE: This research study is collecting and storing tissue samples from patients with head and neck cancer and from healthy participants.
Detailed description
OBJECTIVES:
- Maintain and update a clinical database pertaining to diagnosis and treatment outcome of patients with head and neck cancer.
- Develop a repository of biospecimens from these patients.
OUTLINE: Tumor tissue samples and/or bronchial washings are collected from patients undergoing planned surgery and/or bronchoscopy, respectively. Buccal swabs and/or mouthwash samples and saliva samples are collected. Patients also undergo blood sample collection at baseline and then every 2-6 months thereafter.
Healthy participants contribute blood samples, buccal swabs, and mouthwash samples at baseline only.
Information about medical and family history and cancer risk factors is also collected.
PROJECTED ACCRUAL: No limit.
FOLLOW UP: Indefinite, until date of death or lost to follow up.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 9999 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Other: biologic sample preservation procedure, Other: medical chart reviewNon-tumor volunteers will be asked to participate at the time that they are attending a head and neck cancer screening clinic or at the time they are accompanying a patient to their appointment at the head and neck clinic. Intake sheets and biological specimens contributed by volunteers will be coded at the time of collection so that no identifiers are obtained. These specimens will not be linked to identifiers. |
| Head and Neck Tumor patients | – | Other: biologic sample preservation procedure, Other: medical chart reviewEligible patients will be identified at the Vanderbilt Head \& Neck Clinic by clinical and research staff. An appropriately trained staff member will discuss the protocol with the patient (including, risks, benefits, alternatives, etc.). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Head and neck tumor patients, aged 18 and older and Healthy volunteers, aged 18 and older.
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 | Head and Neck Tumor patients, Healthy Volunteers |
| medical chart review | Other | Head and Neck Tumor patients, Healthy Volunteers |
Primary outcome
Maintenance of a clinical database pertaining to diagnosis and treatment outcome of patients with head and neck cancer
Time frame: ongoing
Collection of data for both groups from the Vanderbilt Otolaryngology Patient Intake questionnaire as well as the medical record, such as medical history, family history, and exposures to risk factors for cancer (tobacco and alcohol use), and results of tests related to diagnosis of tumor and treatment response (for tumor patients only).
Development of a repository of biospecimens
Time frame: ongoing
Collection of blood, tissue, saliva, bronchial washings and other specimens as indicated from both tumor and healthy patients.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Eben Rosenthal, MD principal investigator
Vanderbilt University Medical Center
4 sites in 1 country: 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 Vanderbilt University Medical Center at 4 sites in United States.
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: looking for participants now, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brandee Brown (615-936-4896, brandee.t.brown@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintenance of a clinical database pertaining to diagnosis and treatment outcome of patients with head and neck cancer (time frame: ongoing). The study lists 2 primary outcomes in all. 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 28 Oct 2025.