Head and Neck Squamous Cell CarcinomaHNCAX01NCT04003025
Body Composition and Prognosis in Head and Neck Squamous Cell Carcinoma (HNSCC)
An observational study of Head and Neck Squamous Cell Carcinoma, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
This is a retrospective study in patients with cancer of the oral cavity, pharynx, and larynx. Imaging exams of these patients will be analyzed with the objective of developing and validating a clinically applicable method for evaluation of cachexia and/or sarcopenia in a patient with head and neck cancer from… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jul 2019to 1 Mar 2021
- 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 to 110 years
- All sexes
- Adult, Older adult
Study population: Patients who have histological or cytological evidence of oropharynx squamous cell carcinoma, oral cavity, larynx or hypopharynx, locally advanced treated only at Sao Paulo Cancer Institute (ICESP).
Who may be able to join
- Patients who have histological or cytological evidence of oropharynx squamous cell carcinoma, oral cavity, larynx or hypopharynx, locally advanced treated only at Sao Paulo Cancer Institute (ICESP).
Who cannot join
- patients with no tomography available.
- head and neck cancer with tumor at other sites such as thyroid, paranasal sinus, skin and nasopharynx, or other histology other than squamous cell carcinoma
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Câncer do Estado de São Paulo
São Paulo, São Paulo, 01246-000
About this study
Official title: Body Composition Evaluation as a Prognosis Determinant in Head and Neck Squamous Cell Carcinoma (HNSCC)
This is a retrospective study in patients with cancer of the oral cavity, pharynx, and larynx. Imaging exams of these patients will be analyzed with the objective of developing and validating a clinically applicable method for evaluation of cachexia and/or sarcopenia in a patient with head and neck cancer from musculature imaging of the neck. Indeed, the prognostic influence of body composition will be evaluated.
Read the detailed description
Epidermoid carcinoma (SCC) is the predominant histology of cancers of the oral cavity, pharynx, and larynx. In Brazil, 11,200 new cases of oral cavity cancer are estimated in men and 3,500 in women for each year of the 2018-2019 biennium. The disease causes high mortality and morbidity, affecting swallowing and dysphagia, leading to weight loss and cachexia. Cancer cachexia is marked by involuntary muscle loss leading to progressive functional impairment and can not be reversed by traditional nutritional support. Recent publications show that muscle mass can predict certain outcomes such as survival. Methods for assessing body composition have been developed and validated for research, and the area of a skeletal muscle, which can be measured by cross-sectional images, is a valid marker of total body mass. The CT evaluation of the region of the third and fourth lumbar vertebra (L3-L4) are accurate and accepted as a method for evaluating body composition. However, given the locoregional nature of the dissemination of this SCC, usually the L3-L4 level is not available on CT, and this is a limitation for the use of CT to assess cachexia in these patients. This study will be divided into three steps. In the first step, 20 patients with cross-sectional CT images of patients with head and neck cancer diagnosis will be selected to verify the intra-class variation at different evaluation times. The second step aims to evaluate the correlation of the muscular area obtained through the L3 region with the area of the neck muscles. The third step will evaluate the prognostic role of the neck muscle area of HNSCC patients. The area of the neck muscle of the first CT scan obtained prior to the beginning of treatment will be evaluated and the ratio of this area with the survival rate will be calculated.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival in HNSCC
Survival will be measured to understand the prognostic impact of skeletal muscle index in HNSCC
Measured: 1 year
Secondary outcomes (1)
Skeletal muscle index of L3 and C3
The correlation of L3 and C3 will measured as alternative areas of skeletal muscle index to evaluate sarcopenia/cachexia.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start30 Jul 2019
- Primary completion1 Mar 2021
- Study completion1 Mar 2021 (estimated)
Why it stopped: The proposed analysis was not feasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003025
- Sponsor's protocol ID
- NP 1454/19
- Acronym
- HNCAX01
- Status last verified
- Apr 2022
- First submitted
- 27 Jun 2019
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Composition Evaluation as a Prognosis Determinant in Head and Neck Squamous Cell Carcinoma (HNSCC)
- ClinicalTrials.gov ID
- NCT04003025
- Acronym / sponsor ID
- HNCAX01 / NP 1454/19
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The proposed analysis was not feasible.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 1 Jul 2019 (actual)
- 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 retrospective study in patients with cancer of the oral cavity, pharynx, and larynx. Imaging exams of these patients will be analyzed with the objective of developing and validating a clinically applicable method for evaluation of cachexia and/or sarcopenia in a patient with head and neck cancer from musculature imaging of the neck. Indeed, the prognostic influence of body composition will be evaluated.
Detailed description
Epidermoid carcinoma (SCC) is the predominant histology of cancers of the oral cavity, pharynx, and larynx. In Brazil, 11,200 new cases of oral cavity cancer are estimated in men and 3,500 in women for each year of the 2018-2019 biennium. The disease causes high mortality and morbidity, affecting swallowing and dysphagia, leading to weight loss and cachexia. Cancer cachexia is marked by involuntary muscle loss leading to progressive functional impairment and can not be reversed by traditional nutritional support. Recent publications show that muscle mass can predict certain outcomes such as survival. Methods for assessing body composition have been developed and validated for research, and the area of a skeletal muscle, which can be measured by cross-sectional images, is a valid marker of total body mass. The CT evaluation of the region of the third and fourth lumbar vertebra (L3-L4) are accurate and accepted as a method for evaluating body composition. However, given the locoregional nature of the dissemination of this SCC, usually the L3-L4 level is not available on CT, and this is a limitation for the use of CT to assess cachexia in these patients. This study will be divided into three steps. In the first step, 20 patients with cross-sectional CT images of patients with head and neck cancer diagnosis will be selected to verify the intra-class variation at different evaluation times. The second step aims to evaluate the correlation of the muscular area obtained through the L3 region with the area of the neck muscles. The third step will evaluate the prognostic role of the neck muscle area of HNSCC patients. The area of the neck muscle of the first CT scan obtained prior to the beginning of treatment will be evaluated and the ratio of this area with the survival rate will be calculated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who have histological or cytological evidence of oropharynx squamous cell carcinoma, oral cavity, larynx or hypopharynx, locally advanced treated only at Sao Paulo Cancer Institute (ICESP).
Key inclusion criteria (1 listed)
- Patients who have histological or cytological evidence of oropharynx squamous cell carcinoma, oral cavity, larynx or hypopharynx, locally advanced treated only at Sao Paulo Cancer Institute (ICESP).
Key exclusion criteria (2 listed)
- patients with no tomography available.
- head and neck cancer with tumor at other sites such as thyroid, paranasal sinus, skin and nasopharynx, or other histology other than 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
Overall survival in HNSCC
Time frame: 1 year
Survival will be measured to understand the prognostic impact of skeletal muscle index in HNSCC
1 secondary outcome
Skeletal muscle index of L3 and C3
Time frame: 1 years
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 20 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Squamous Cell Carcinoma, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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 2 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 20 Apr 2022. 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 Brazil. 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.
What does the primary outcome measure?
Overall survival in HNSCC (time frame: 1 year). 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 20 Apr 2022.