Influence of Nutrition and Sarcopenia on Esophageal Cancer Outcomes

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06314516

Acronym

INSPECT

Enrollment

1717

Registered

2024-03-18

Start date

2017-12-27

Completion date

2024-02-28

Last updated

2024-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer, Sarcopenia

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results