Frailty in Patients With Gastrointestinal Cancer Who Are Undergoing Major Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-13

Study Completion Date

2027-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastrointestinal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Major surgery for gastrointestinal cancer

Patients with gastrointestinal cancer who are scheduled for major surgery

Frailty survey

Intervention Type OTHER

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

Interventions

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Frailty survey

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

Intervention Type OTHER

Eligibility Criteria

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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