Influence of Nutrition and Sarcopenia on Esophageal Cancer Outcomes

NCT ID: NCT06314516

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1717 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-27
• Study Completion Date: 2024-02-28

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.

Conditions

Esophageal Cancer; Sarcopenia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Body Composition

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

No interventions assigned to this group

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imperial College London

OTHER

Sponsor Role: collaborator

Benaroya Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donald E Low, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Mason Medical Center

Locations

Virginia Mason Medical Center

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CRP17122

Identifier Type: -

Identifier Source: org_study_id