SCCHNQDV2bNCT02878655
Evaluation of the Overall Quality of Life After the Neck Dissection Retro-spinal Sector (IIb), in Squamous Cell Carcinomas Clinical and Radiological N0 VADS
An observational study of SCCHN, run by University Hospital, Caen at 1 site in France.
Trial summary
The nodal involvement in squamous cell carcinomas of the upper aerodigestive tract (VADS) is one of the main factors of poor prognosis, justifying the surgical management of neck dissection as a reference treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SCCHN
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Dec 2018
- 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 SCCHN, N0 clinical and radiological, enjoying a dissection IIb sector
Who may be able to join
- Patient with SCCHN histologically proven N0 clinical and radiological
- Neoplastic Location: oral cavity, oropharynx, hypopharynx, larynx
- Patient candidate for a neck dissection fonctonnel
- Life expectancy> 3 months
- Stable patient not exhibiting at the time of recurrence sign of examination or other scalable neoplasia
- Age over 18 ans
- Patient was informed of the study
- Patient fluent French
Who cannot join
- Patients with a history of malignancy, outside a basal cell cancer or cancer of the neck treated and cured
- Patient has at the time of examination of recurrence of signs or other scalable neoplasia
- Uncontrolled Infectious diseases
- Neoadjuvant radiotherapy
- Patient nursing or pregnant or lack of contraception during their reproductive
- Intercurrent pathology involving life-threatening
- Any medical or psychological condition associated that could compromise the patient's ability to participate in the study
- Inability to submit to medical follow-up study for geographical, social or psychic
Trial locations and contacts
1 site in 1 country.
Roger VIVIEN, MD contact
Emmanuel BABIN contact
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen, 14000
Emmanuel BABIN, MD, PhD
About this study
The nodal involvement in squamous cell carcinomas of the upper aerodigestive tract (VADS) is one of the main factors of poor prognosis, justifying the surgical management of neck dissection as a reference treatment.
Under the influence of the American Hayes Martin, it was considered until the 1960s that "over the intervention was, the greater the chance of recovery was". But has since been developed by the Argentine Osvaldo Suarez the concept of functional course, which consists of resection of lymph node tissue while retaining the main structures (muscles, nerves, vessels), as opposed to the recess radical which is reserved for the invasive metastasis.
In addition to these notions, our job is to evaluate the quality of life of patients with SCCHN, N0 clinical and radiological, enjoying a functional neck dissection including IIb sector to support the approach which would be to stop the systematic inclusion of this territory.
- Conditions
- SCCHN
- Keywords
- N0 clinical and radiological, dissection IIb sector
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Annalogue Scale for Global Quality of Life
(rate between 0 and 10)
Measured: change over baseline and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startFeb 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCCHNStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878655
- Sponsor's protocol ID
- 14-059
- Acronym
- QDV2b
- Status last verified
- Jul 2018
- First submitted
- 27 May 2016
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Overall Quality of Life After the Neck Dissection Retro-spinal Sector (IIb), in Squamous Cell Carcinomas Clinical and Radiological N0 VADS
- ClinicalTrials.gov ID
- NCT02878655
- Acronym / sponsor ID
- QDV2b / 14-059
- Conditions
- SCCHN
- Keywords
- N0 clinical and radiological, dissection IIb sector
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 25 Aug 2016 (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 nodal involvement in squamous cell carcinomas of the upper aerodigestive tract (VADS) is one of the main factors of poor prognosis, justifying the surgical management of neck dissection as a reference treatment.
Under the influence of the American Hayes Martin, it was considered until the 1960s that "over the intervention was, the greater the chance of recovery was". But has since been developed by the Argentine Osvaldo Suarez the concept of functional course, which consists of resection of lymph node tissue while retaining the main structures (muscles, nerves, vessels), as opposed to the recess radical which is reserved for the invasive metastasis.
In addition to these notions, our job is to evaluate the quality of life of patients with SCCHN, N0 clinical and radiological, enjoying a functional neck dissection including IIb sector to support the approach which would be to stop the systematic inclusion of this territory.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with SCCHN, N0 clinical and radiological, enjoying a dissection IIb sector
Key inclusion criteria (8 listed)
- Patient with SCCHN histologically proven N0 clinical and radiological
- Neoplastic Location: oral cavity, oropharynx, hypopharynx, larynx
- Patient candidate for a neck dissection fonctonnel
- Life expectancy> 3 months
- Stable patient not exhibiting at the time of recurrence sign of examination or other scalable neoplasia
Key exclusion criteria (8 listed)
- Patients with a history of malignancy, outside a basal cell cancer or cancer of the neck treated and cured
- Patient has at the time of examination of recurrence of signs or other scalable neoplasia
- Uncontrolled Infectious diseases
- Neoadjuvant radiotherapy
- Patient nursing or pregnant or lack of contraception during their reproductive
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
Visual Annalogue Scale for Global Quality of Life
Time frame: change over baseline and month 6
(rate between 0 and 10)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
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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.
Roger VIVIEN, MD contact
Emmanuel BABIN contact
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 SCCHN, run by University Hospital, Caen at 1 site in France.
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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 18 Jul 2018. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roger VIVIEN, MD (babin-e@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Annalogue Scale for Global Quality of Life (time frame: change over baseline and month 6). 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 18 Jul 2018.