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NCT06314516 Clinical Trial

Influence of Nutrition and Sarcopenia on Esophageal Cancer Outcomes

Esophageal Cancer Clinical Trial

— INSPECT  

Official title:
Influence of Nutrition and SarcoPenia on Esophageal Cancer ouTcomes (INSPECT Study)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06314516
Other study ID # CRP17122
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 27, 2017
Est. completion date February 28, 2024

Study information
Verified date March 2024
Source Benaroya Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Prospective multicenter longitudinal (observational) study recruiting from tertiary centers for the surgical management of esophageal cancer; Virginia Mason Medical Center (Seattle, USA) and St Mary's Hospital (Imperial College, London, UK). This is intended to be a pilot study.

Description:

Patients undergoing curative treatment for esophageal cancer will be recruited at the time of routine clinical assessment shortly following initial diagnosis and will undergo clinical and radiological evaluation at two study time points: (1) staging investigation (e.g. laparoscopy or endoscopy) and (2) definitive surgical resection. Study time points have been judiciously chosen to coincide with interventions that form part of patient's routine clinical care. It is intended that sampling will occur on the day of each intervention/surgery following a routine period of fasting.

Recruitment information / eligibility
Status Completed
Enrollment 1717
Est. completion date February 28, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Patients with the following characteristics will be eligible for inclusion in this study: i. aged 18-90 years ii. newly diagnosed (prior to treatment) with esophageal and/or gastroesophageal junctional cancer (adeno- or squamous cell carcinoma) iii. planning to undergo curative treatment, including surgical resection with or without neoadjuvant therapy Exclusion Criteria: - Patients with the following characteristics will not be eligible for inclusion in this study: i. pregnant females ii. without malignant esophageal disease iii. inability or unwillingness to provided informed written consent

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Virginia Mason Medical Center Seattle Washington

Sponsors (2)
Lead Sponsor Collaborator
Benaroya Research Institute Imperial College London

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Longitudinal variation in body composition Establish the effect of patient and disease-specific factors on body composition in a global cohort of patients undergoing esophagectomy for cancer Approximately 1 year
Secondary Patient and disease-specific factors Provide a benchmark for future reporting of body composition and to explore the association between body composition and outcomes of esophageal cancer surgery Approximately 1 year
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