Influence of Nutrition and Sarcopenia on Esophageal Cancer Outcomes

Completed

• Conditions: Esophageal Cancer; Sarcopenia

• Registration Number: NCT06314516
• Lead Sponsor: Benaroya Research Institute

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-12-27
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28
• Status Verified: 2024-03
• Study First Submitted: 2024-03-11
• Study First Submitted QC: 2024-03-11
• Study First Posted: 2024-03-18
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1717

Inclusion Criteria

• Patients with the following characteristics will be eligible for inclusion in this study:

  • Age 18-90 years
  • Newly diagnosed (prior to treatment) with esophageal and/or gastroesophageal junctional cancer (adeno- or squamous cell carcinoma)
  • Planning to undergo curative treatment, including surgical resection with or without neoadjuvant therapy

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Exclusion Criteria

• Patients with the following characteristics will not be eligible for inclusion in this study:

  • Pregnant females
  • Without malignant esophageal disease
  • Inability or unwillingness to provided informed written consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Longitudinal variation in body composition	Approximately 1 year	Establish the effect of patient and disease-specific factors on body composition in a global cohort of patients undergoing esophagectomy for cancer

Secondary Outcome Measures

Name	Time	Method
Patient and disease-specific factors	Approximately 1 year	Provide a benchmark for future reporting of body composition and to explore the association between body composition and outcomes of esophageal cancer surgery

Trial Locations

Locations (1)

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States