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Completed

NCT Number: NCT06314516

Influence of Nutrition and Sarcopenia on Esophageal Cancer Outcomes

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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Longitudinal variation in body composition

    Time frame: 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 outcomes

  1. Patient and disease-specific factors

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Benaroya Research Institute

Other

Collaborators

  • Imperial College London

Registry information

Official study title

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

Acronym: INSPECT

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Mar 18, 2024
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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