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
• Status: Completed
• 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
• 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:

• 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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Sarcopenia

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