Recruiting

Observational Study

Sponsor:

The Guthrie Clinic

Code:

NCT05694338

Conditions

Gastrointestinal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Frailty survey

Study Details

Brief summary:

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.

Conditions

Gastrointestinal Cancer

Study ID

NCT05694338

Start date

Mar 13, 2023

Status verified date

Apr, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Major surgery for gastrointestinal cancer

Patients with gastrointestinal cancer who are scheduled for major surgery

Interventions

Frailty survey

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

Primary outcome measure

  • Percent of patients considered frail assessed by Clinical Risk Analysis Index (RAI-C) Scores of 21 or higher [ Time Frame: pre-operative ]

Central Contacts and Locations

Central contacts

Burt Cagir, MD

15708874882Burt.Cagir@guthrie.org

Locations

Robert Packer Hospital

Recruiting

Sayre, Pennsylvania, United States, 18840

Contacts

Rebekah Macfie, MD

Rebekah.Macfie@guthrie.org

More Information

Sponsor

The Guthrie Clinic

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Guthrie Clinic on 2026-04-29.