4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Body Composition and Prognosis in Head and Neck Squamous Cell Carcinoma (HNSCC) (HNCAX01)

Body Composition and Prognosis in Head and Neck Squamous Cell Carcinoma (HNSCC) (HNCAX01)

Study Description
Brief 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 musculature imaging of the neck. Indeed, the prognostic influence of body composition will be evaluated.

Condition or disease
Head and Neck Squamous Cell Carcinoma

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
Layout table for study information
Study Type : Observational
Estimated Enrollment : 1235 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Body Composition Evaluation as a Prognosis Determinant in Head and Neck Squamous Cell Carcinoma (HNSCC)
Actual Study Start Date : July 30, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Overall survival in HNSCC [ Time Frame: 1 year ]
    Survival will be measured to understand the prognostic impact of skeletal muscle index in HNSCC


Secondary Outcome Measures :
  1. Skeletal muscle index of L3 and C3 [ Time Frame: 1 years ]
    The correlation of L3 and C3 will measured as alternative areas of skeletal muscle index to evaluate sarcopenia/cachexia.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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).
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Gilberto Castro Junior, PhD MD +55 11 3896-2686 gilberto.castro@usp.br

Locations
Layout table for location information
Brazil
Instituto do Câncer do Estado de São Paulo Recruiting
São Paulo, SP, Brazil, 01246-000
Contact: Gilberto de Castro Junior, MD, PhD    +55 11 3896-2686    gilberto.castro@usp.br   
Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo
Tracking Information
First Submitted Date June 27, 2019
First Posted Date July 1, 2019
Last Update Posted Date February 12, 2020
Actual Study Start Date July 30, 2019
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 27, 2019)
Overall survival in HNSCC [ Time Frame: 1 year ]
Survival will be measured to understand the prognostic impact of skeletal muscle index in HNSCC
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 27, 2019)
Skeletal muscle index of L3 and C3 [ Time Frame: 1 years ]
The correlation of L3 and C3 will measured as alternative areas of skeletal muscle index to evaluate sarcopenia/cachexia.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Body Composition and Prognosis in Head and Neck Squamous Cell Carcinoma (HNSCC)
Official Title Body Composition Evaluation as a Prognosis Determinant in Head and Neck Squamous Cell Carcinoma (HNSCC)
Brief 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 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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).
Condition Head and Neck Squamous Cell Carcinoma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 27, 2019)
1235
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 110 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Gilberto Castro Junior, PhD MD +55 11 3896-2686 gilberto.castro@usp.br
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT04003025
Other Study ID Numbers NP 1454/19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Instituto do Cancer do Estado de São Paulo
Study Sponsor Instituto do Cancer do Estado de São Paulo
Collaborators Not Provided
Investigators Not Provided
PRS Account Instituto do Cancer do Estado de São Paulo
Verification Date February 2020