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Influence of Nutrition and Sarcopenia on Esophageal Cancer Outcomes (INSPECT)

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Benaroya Research Institute

Status

Completed

Conditions

Esophageal Cancer
Sarcopenia

Study type

Observational

Funder types

Other

Identifiers

NCT06314516
CRP17122

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,717 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No 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

Trial design

1,717 participants in 1 patient group

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

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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