Influence of Nutrition and Sarcopenia on Esophageal Cancer Outcomes

NCT06314516 | Completed

• 1 other identifier: CRP17122
• Study Type: observational
• Target: 1,717
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer; Sarcopenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient and disease-specific factors

  Approximately 1 year

Study Arms (1)

Body Composition

Radiologic assessment of fat and muscle components of body composition at presentation and following initial treatment for esophageal cancer.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

International cohort of patients presenting with regional {Stage 2 and 3} esophageal cancer who are considered appropriate candidates for surgical therapy.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Benaroya Research Institute: lead
• Imperial College London: collaborator

Study Sites (1)

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Sarcopenia

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Donald E Low, MD

  Virginia Mason Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: December 27, 2017
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)