Head and Neck CancerTESTNCT01412749
TEST: Registry for Endoscopic Head and Neck Surgery
An observational study of Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this data review research study is to create a registry database using information (data) collected from patients who have had Endoscopic Head and Neck Surgery (eHNS). Researchers want to use the registry database to learn more about short-term and long-term outcomes for patients who have eHNS. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head and Neck Cancer
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals diagnosed with head and neck cancer and are a candidate to have endoscopic head and neck surgery (eHNS) for definitive resection of the primary tumor.
Who may be able to join
- Patients diagnosed with head and neck cancer who are candidates for definitive surgical resection of the primary tumor and who, in the opinion of the treating MDACC physician, are candidates for eHNS will be included
- Medically fit for an endoscopic surgical resection by consensus of MDACC surgical oncology and anesthesia faculty (common best practice criteria).
- Date of records anticipated to be reviewed would be from March 1, 2011 to June 30, 2013
- Approximately 200 patients are expected to fit the criteria above in order to be eligible for prospective data collection and review.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transoral Endoscopic Surgery Trial (TEST): A Registry for Endoscopic Head and Neck Surgery (eHNS)
The goal of this data review research study is to create a registry database using information (data) collected from patients who have had Endoscopic Head and Neck Surgery (eHNS). Researchers want to use the registry database to learn more about short-term and long-term outcomes for patients who have eHNS.
1.1 Primary Objective: To develop a registry database of patients who have had eHNS.
Read more
1.2 Secondary Objective: To evaluate short-term oncologic parameters and functional outcomes, operative for patients undergoing eHNS performed at M.D. Anderson Cancer Center (MDACC).
1.3 Tertiary Objective: To collect data on long-term oncologic outcomes including local and distant failure and survival following eHNS.
Read the detailed description
Information from medical records will be collected and entered into the registry database at M. D. Anderson Cancer Center for future research related to cancer.
The information collected from medical records will include, but is not limited to, medical history, sex, age, race, gender, type and stage of disease, type of treatment(s) you have received, radiology reports, surgical and pathological reports, the results of any test(s), treatment(s) and/or surgery performed.
This is a registry study evaluating endoscopic head and neck surgery. The data from the surgical resection will be descriptive. Comparisons will be made to non-robotic, open historical controls and patients treated with radiation therapy, based on literature reports.
- Conditions
- Head and Neck Cancer
- Keywords
- registry, database, eHNS, Endoscopic Head and Neck Surgery, Transoral Endoscopic Surgery Trial, TEST, melanoma, head and neck surgery
- Medical subject headings
- Head and Neck Neoplasms, Melanoma
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 |
|---|---|---|
| eHNS Participant Registry | Participants diagnosed with head and neck cancer who are candidates for definitive surgical resection of the primary tumor and who are candidates for eHNS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
eHNS Registry
Registry database using information (data) collected from participants who have had eHNS.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2013
Why it stopped: Low Accrual
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 M.D. Anderson 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christ Holsinger, MD, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412749
- Sponsor's protocol ID
- DR11-0131
- Acronym
- TEST
- Status last verified
- Jun 2013
- First submitted
- 8 Aug 2011
- Last updated
- 28 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transoral Endoscopic Surgery Trial (TEST): A Registry for Endoscopic Head and Neck Surgery (eHNS)
- ClinicalTrials.gov ID
- NCT01412749
- Acronym / sponsor ID
- TEST / DR11-0131
- Conditions
- Head and Neck Cancer
- Keywords
- registry, database, eHNS, Endoscopic Head and Neck Surgery, Transoral Endoscopic Surgery Trial, TEST, melanoma, head and neck surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low Accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jun 2013 (actual)
- First posted
- 9 Aug 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.
The goal of this data review research study is to create a registry database using information (data) collected from patients who have had Endoscopic Head and Neck Surgery (eHNS). Researchers want to use the registry database to learn more about short-term and long-term outcomes for patients who have eHNS.
1.1 Primary Objective: To develop a registry database of patients who have had eHNS.
1.2 Secondary Objective: To evaluate short-term oncologic parameters and functional outcomes, operative for patients undergoing eHNS performed at M.D. Anderson Cancer Center (MDACC).
1.3 Tertiary Objective: To collect data on long-term oncologic outcomes including local and distant failure and survival following eHNS.
Detailed description
Information from medical records will be collected and entered into the registry database at M. D. Anderson Cancer Center for future research related to cancer.
The information collected from medical records will include, but is not limited to, medical history, sex, age, race, gender, type and stage of disease, type of treatment(s) you have received, radiology reports, surgical and pathological reports, the results of any test(s), treatment(s) and/or surgery performed.
This is a registry study evaluating endoscopic head and neck surgery. The data from the surgical resection will be descriptive. Comparisons will be made to non-robotic, open historical controls and patients treated with radiation therapy, based on literature reports.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eHNS Participant Registry | – | –Participants diagnosed with head and neck cancer who are candidates for definitive surgical resection of the primary tumor and who are candidates for eHNS. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals diagnosed with head and neck cancer and are a candidate to have endoscopic head and neck surgery (eHNS) for definitive resection of the primary tumor.
Key inclusion criteria (4 listed)
- Patients diagnosed with head and neck cancer who are candidates for definitive surgical resection of the primary tumor and who, in the opinion of the treating MDACC physician, are candidates for eHNS will be included
- Medically fit for an endoscopic surgical resection by consensus of MDACC surgical oncology and anesthesia faculty (common best practice criteria).
- Date of records anticipated to be reviewed would be from March 1, 2011 to June 30, 2013
- Approximately 200 patients are expected to fit the criteria above in order to be eligible for prospective data collection and review.
Key exclusion criteria (1 listed)
- None.
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
eHNS Registry
Time frame: 3 years
Registry database using information (data) collected from participants who have had eHNS.
Results and safety
The study was stopped early (reason given: Low Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2013.
- UT MD Anderson Cancer Center websiteLink 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.
Christ Holsinger, MD study chair
UT MD Anderson 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 Cancer, run by M.D. Anderson 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: stopped early, as of the sponsor's last update on 28 Jun 2013. 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 was stopped early (reason given: Low Accrual). Results are not available in the source record.
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?
eHNS Registry (time frame: 3 years). 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 Jun 2013.