Squamous Cell CarcinomaH&NNCT01484769
Method Development and Assessment of the Effects of Tobacco Products on Oral Cavity Cells
An observational study of Squamous Cell Carcinoma, run by University of Louisville at 3 sites in United States.
Trial summary
Collection of tissues for analysis from patients undergoing elective neck dissection. The hypothesis of the study is that specific genetic alterations occur in head and neck cancers that have spread to regional and/or distant sites, and these alterations can be identified from biopsy specimens to allow more accurate… Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Squamous Cell Carcinoma
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2005to Jun 2012
- 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults and minors diagnosed with squamous cell carcinoma of the head and neck that will undergo elective neck dissection surgery at either Norton Hospital, Kosair Children's Hospital, or University of Louisville Hospital.
Who may be able to join
- All patients with biochemical evidence of squamous cell carcinoma of the head and neck.
Who cannot join
- Patients without biomedical evidence of squamous cell carcinoma.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Kosair Children's Hospital
Louisville, Kentucky, 40202
Norton Hospital
Louisville, Kentucky, 40202
University of Louisville
Louisville, Kentucky, 40202
About this study
Collection of tissues for analysis from patients undergoing elective neck dissection.
The hypothesis of the study is that specific genetic alterations occur in head and neck cancers that have spread to regional and/or distant sites, and these alterations can be identified from biopsy specimens to allow more accurate staging of tumor and better treatment planning.
Read the detailed description
The standard of care for the treatment of most squamous cell carcinoma of the head and neck is surgical extirpation of the primary tumor and elective neck dissection to remove regional nodes at risk for spread. Via this treatment regimen, the investigators will be able to prospectively obtain tissues for analysis from patients undergoing elective neck dissection.
The specific aims of this study are to compare gene expression between head and neck tumors with and without regional lymph node metastases, and to compare gene expression between head and neck tumor with and without distant metastases.
- Conditions
- Squamous Cell Carcinoma
- Medical subject headings
- Carcinoma, Squamous Cell
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startJul 2005
- Primary completionJun 2011 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484769
- Sponsor's protocol ID
- 360.05
- Acronym
- H&N
- Status last verified
- Apr 2017
- First submitted
- 30 Nov 2011
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Method Development and Assessment of the Effects of Tobacco Products on Oral Cavity Cells
- ClinicalTrials.gov ID
- NCT01484769
- Acronym / sponsor ID
- H&N / 360.05
- Conditions
- Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 2 Dec 2011 (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.
Collection of tissues for analysis from patients undergoing elective neck dissection.
The hypothesis of the study is that specific genetic alterations occur in head and neck cancers that have spread to regional and/or distant sites, and these alterations can be identified from biopsy specimens to allow more accurate staging of tumor and better treatment planning.
Detailed description
The standard of care for the treatment of most squamous cell carcinoma of the head and neck is surgical extirpation of the primary tumor and elective neck dissection to remove regional nodes at risk for spread. Via this treatment regimen, the investigators will be able to prospectively obtain tissues for analysis from patients undergoing elective neck dissection.
The specific aims of this study are to compare gene expression between head and neck tumors with and without regional lymph node metastases, and to compare gene expression between head and neck tumor with and without distant metastases.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults and minors diagnosed with squamous cell carcinoma of the head and neck that will undergo elective neck dissection surgery at either Norton Hospital, Kosair Children's Hospital, or University of Louisville Hospital.
Key inclusion criteria (1 listed)
- All patients with biochemical evidence of squamous cell carcinoma of the head and neck.
Key exclusion criteria (1 listed)
- Patients without biomedical evidence of squamous cell carcinoma.
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
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
Related trials for Squamous Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Squamous Cell Carcinoma, run by University of Louisville at 3 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?
The sponsor lists 1 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: withdrawn, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study was withdrawn before enrolling participants, so there are no results.
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.
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 10 Apr 2017.