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NCT Number: NCT05694338

Frailty in Patients With Gastrointestinal Cancer Who Are Undergoing Major Surgery

This research is for patients who have gastrointestinal cancer and have a planned major surgery. The purpose of this research is to identify cancer patients who may be at risk for frailty. Frailty is common in older adults and may include symptoms of weight loss, weakness, fatigue, low activity, slow walking and other illnesses. Frailty may increase the risk of problems after major surgery. The study will involve a survey, a blood sample, and a review of medical records.

Recruiting

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Key information

Conditions

Gastrointestinal Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Guthrie Medical Group, East Corning, New York, United States

Loading trial locations.

About this study

The goals of the study are to:

  • Describe the rate of frailty in surgical cancer patients
  • Assess if frailty correlates with problems (adverse outcomes) after major surgery

Participants taking part will be asked to complete a survey to assess frailty before surgery. The frailty survey is referred to as the Clinical Risk Analysis Index (RAI-C).

Participants will have about 10 ml (2 teaspoons) of blood drawn before surgery. Blood tests will include complete blood count (CBC), vitamin A, creatinine, C-Reactive Protein (CRP), DHEA, albumin, and prealbumin.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years old or older
  • histologically proven gastrointestinal malignancy
  • referral for elective major surgical procedures at including operations for upper and lower gastrointestinal malignancies and hepato-pancreato-biliary
  • referral for neoadjuvant treatment followed by any of the above major surgical procedures

Exclusion criteria

  • under 18 years
  • pregnant women

Treatment and study plan

Frailty survey

Other

Frailty survey using the Clinical Risk Analysis Index (RAI-C).

Primary outcomes

  1. Percent of patients considered frail assessed by Clinical Risk Analysis Index (RAI-C) Scores of 21 or higher

    Time frame: pre-operative

    Assess Clinical Risk Analysis Index (RAI-C) Scores in rural patients referred for major abdominal surgeries. Survey values will be added to yield a final RAI-C score between 0 and 81. Percent of patients considered frail will be defined as Clinical Risk Analysis Index (RAI-C) Scores of 21 or higher

Secondary outcomes

  1. Adverse outcomes after major surgery

    Time frame: 30 days post-operative

    Assess adverse outcomes postoperatively and if their is a correlation with the frailty score

Study contacts

Contact information is provided by the study sponsor or research team.

Burt Cagir, MD

CONTACT

[email protected]

15708874882

Sponsors and collaborators

Lead sponsor

The Guthrie Clinic

Other

Registry information

Official study title

A Descriptive and Comparative Analysis of Frailty in Rural Versus Urban Cancer Patients Undergoing Major Surgical Oncologic Procedures

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jan 23, 2023
Registry last updated
Apr 29, 2026

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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