Head and Neck CancersNCT00580203
Collection Of Tissue, Blood, and Other Specimens From Patients With Head and Neck Tumors To Study the Causes, Diagnosis, Prevention and Treatment of Cancers
An observational study of Head and Neck Cancers, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This is a protocol to collect tissues, blood, and other specimens from patients with malignant or nonmalignant diseases of the head and neck. Collected specimens will be used in laboratory studies to investigate the growth, development, and transformation of normal and abnormal cells in the future. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head and Neck Cancers
- How many people
- 1,468 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to 12 Nov 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with head and neck diseases who have had tissue, serum, urine, or other specimens removed or collected for diagnostic or therapeutic purposes.
Who may be able to join
- Patients with head and neck diseases are eligible if they have had tissue, serum, urine, or other specimens removed or collected for diagnostic or therapeutic purposes.
- Patients will be entered onto this protocol without preference for any racial or ethnic group.
- Patients may have received prior chemotherapy, radiation, surgical therapy, immunotherapy, or differentiation therapy.
- The specimen collected must be large enough to allow conventional testing necessary for patient care, with the portion of the specimen reserved for research laboratory analysis excised from residual tissue that would otherwise have been discarded.
Who cannot join
- Patients not giving informed consent will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Collection of Tissue, Blood, and Other Specimens From Patients With Head and Neck Diseases to Study the Causes, Diagnosis, Prevention and Treatment of Cancers
This is a protocol to collect tissues, blood, and other specimens from patients with malignant or nonmalignant diseases of the head and neck. Collected specimens will be used in laboratory studies to investigate the growth, development, and transformation of normal and abnormal cells in the future.
Read the detailed description
This is a protocol to collect tissues, blood, and other specimens from patients with malignant or nonmalignant diseases of the head and neck. Collected specimens will be used in laboratory studies to investigate the growth, development, and transformation of normal and abnormal cells in the future.
- Conditions
- Head and Neck Cancers
- Keywords
- HEENT cancers, larynx, thyroid, sarcoma, specimen analysis
- Medical subject headings
- Head and Neck Neoplasms, Laryngeal Diseases, Thyroid Diseases, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with head and neck cancers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect tissues, blood, and other specimens from patients with malignant or nonmalignant diseases of the head and neck. Specimens will be used to investigate growth, development, and transformation of normal and abnormal cells in the future.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startFeb 2004
- Primary completion12 Nov 2024
- Study completion12 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancersStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,468 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Bhuvanesh Singh, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580203
- Sponsor's protocol ID
- 04-017
- Status last verified
- Nov 2024
- First submitted
- 19 Dec 2007
- Last updated
- 15 Nov 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Tissue, Blood, and Other Specimens From Patients With Head and Neck Diseases to Study the Causes, Diagnosis, Prevention and Treatment of Cancers
- ClinicalTrials.gov ID
- NCT00580203
- Acronym / sponsor ID
- 04-017
- Conditions
- Head and Neck Cancers
- Keywords
- HEENT cancers, larynx, thyroid, sarcoma, specimen analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,468 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Feb 2004 (actual)
- Primary completion
- 12 Nov 2024 (actual)
- Study completion
- 12 Nov 2024 (actual)
- First posted
- 24 Dec 2007 (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.
This is a protocol to collect tissues, blood, and other specimens from patients with malignant or nonmalignant diseases of the head and neck. Collected specimens will be used in laboratory studies to investigate the growth, development, and transformation of normal and abnormal cells in the future.
Detailed description
This is a protocol to collect tissues, blood, and other specimens from patients with malignant or nonmalignant diseases of the head and neck. Collected specimens will be used in laboratory studies to investigate the growth, development, and transformation of normal and abnormal cells in the future.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with head and neck cancers |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with head and neck diseases who have had tissue, serum, urine, or other specimens removed or collected for diagnostic or therapeutic purposes.
Key inclusion criteria (4 listed)
- Patients with head and neck diseases are eligible if they have had tissue, serum, urine, or other specimens removed or collected for diagnostic or therapeutic purposes.
- Patients will be entered onto this protocol without preference for any racial or ethnic group.
- Patients may have received prior chemotherapy, radiation, surgical therapy, immunotherapy, or differentiation therapy.
- The specimen collected must be large enough to allow conventional testing necessary for patient care, with the portion of the specimen reserved for research laboratory analysis excised from residual tissue that would otherwise have been discarded.
Key exclusion criteria (1 listed)
- Patients not giving informed consent will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Collect tissues, blood, and other specimens from patients with malignant or nonmalignant diseases of the head and neck. Specimens will be used to investigate growth, development, and transformation of normal and abnormal cells in the future.
Time frame: 36 months
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 15 Nov 2024.
- Related InfoLink provided by the sponsor.
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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.
Bhuvanesh Singh, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site 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 Cancers, run by Memorial Sloan Kettering Cancer Center at 1 site 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?
The sponsor lists 4 inclusion and 1 exclusion criteria. 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 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Collect tissues, blood, and other specimens from patients with malignant or nonmalignant diseases of the head and neck. Specimens will be used to investigate growth, development, and transformation of normal and abnormal cells in the future. (time frame: 36 months). 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 15 Nov 2024.