NCT04003025

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2019

Completed
29 days until next milestone

Study Start

First participant enrolled

July 30, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

1.6 years

First QC Date

June 27, 2019

Last Update Submit

April 13, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Overall survival in HNSCC

    Survival will be measured to understand the prognostic impact of skeletal muscle index in HNSCC

    1 year

Secondary Outcomes (1)

  • Skeletal muscle index of L3 and C3

    1 years

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Câncer do Estado de São Paulo

São Paulo, São Paulo, 01246-000, Brazil

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2019

First Posted

July 1, 2019

Study Start

July 30, 2019

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

April 20, 2022

Record last verified: 2022-04

Locations