NCT06393647

Brief Summary

In the literature, the relationship between frailty and various blood tests such as beta-2 microglobulin, CRP, procalcitonin, vitamin D, IL-1, and IL-6 has been investigated (2). In our study, the investigators aim to investigate the relationship between frailty status assessed using frailty scale forms (Frailty Scale Version 9) and preoperative levels of Albumin/Creatinine, B12, Folate, Ferritin, hemogram, Sedimentation Rate, and CRP in patients undergoing gastrointestinal malignancy surgery. By identifying the relationship among these parameters, the investigators believe that modifiable factors contributing to frailty in patients at risk can be addressed through appropriate interventions.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Jun 2024

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Jun 2024Dec 2026

First Submitted

Initial submission to the registry

April 27, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 1, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2026

Expected
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

2.4 years

First QC Date

April 27, 2024

Last Update Submit

September 25, 2026

Conditions

Keywords

Frailty ScaleAlbumin/Creatine RatioB12Folate

Outcome Measures

Primary Outcomes (1)

  • Association between preoperative Clinical Frailty Scale (CFS) score and serum albumin-to-creatinine ratio

    Patients' frailty status will be assessed using the Frailty Scale Version 9.There are scores between 1 and 9 on this scale. Patients with a score of 4 or above are defined as fraile.(Association between preoperative Clinical Frailty Scale (CFS) score and serum albumin-to-creatinine ratio.)

    one day before surgery

Secondary Outcomes (4)

  • Association between preoperative Clinical Frailty Scale (CFS) score and B12 levels

    one day before surgery

  • Association between preoperative Clinical Frailty Scale (CFS) score and Folate levels

    one day before surgery

  • Association between preoperative Clinical Frailty Scale (CFS) score and iron levels

    one day before surgery

  • Association between preoperative Clinical Frailty Scale (CFS) score and Hemoglobin/RDW ratio.

    one day before surgery

Study Arms (1)

Undergoing gastrointestinal malignancy surgery

In our study, we aim to investigate the relationship between frailty status assessed using frailty scale form (Frailty Scale Version 9) and preoperative levels of Albumin/Creatinine, B12, Folate, Hemogram in patients undergoing gastrointestinal malignancy surgery.Patients' frailty status will be assessed using the Frailty Scale Version 9.There are scores between 1 and 9 on this scale. Patients with a score of 4 or above are defined as fraile.

Other: Frailty scale forms (Frailty Scale Version 9)

Interventions

In our study, we aim to investigate the relationship between frailty status assessed using frailty scale form (Frailty Scale Version 9) and preoperative levels of Albumin/Creatinine, B12, Folate, Ferritin, Sedimentation Rate, and CRP in patients undergoing gastrointestinal malignancy surgery.

Undergoing gastrointestinal malignancy surgery

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In our study, we aim to investigate the relationship between frailty status assessed using frailty scale form (Frailty Scale Version 9) and preoperative levels of Albumin/Creatine, B12, Folate, Ferritin, Sedimentation Rate, and CRP in patients undergoing gastrointestinal malignancy surgery.

You may qualify if:

  • Patients who are over 65 years old.
  • Patients classified under ASA (American Society of Anesthesiologists) risk groups I, II, and III.
  • Patients with gastrointestinal malignancy undergoing surgery

You may not qualify if:

  • Patients who are under 65 years old.
  • Patients with an ASA score of IV or higher.
  • Patients who refuse to participate in the study.
  • Patients undergoing emergency surgeries will be excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yusuf

Çankaya, Ankara, Turkey (Türkiye)

RECRUITING

Ankara Etlik City Hospital

Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, 06170, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Kim M, Suzuki T, Kojima N, Yoshida H, Yoshida Y, Hirano H, Won CW, Kim H. Association Between Serum beta2 -Microglobulin Levels and Prevalent and Incident Physical Frailty in Community-Dwelling Older Women. J Am Geriatr Soc. 2017 Apr;65(4):e83-e88. doi: 10.1111/jgs.14733. Epub 2017 Jan 31.

    PMID: 28140452BACKGROUND
  • Shamliyan T, Talley KM, Ramakrishnan R, Kane RL. Association of frailty with survival: a systematic literature review. Ageing Res Rev. 2013 Mar;12(2):719-36. doi: 10.1016/j.arr.2012.03.001. Epub 2012 Mar 12.

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yusuf Ozguner

    Ankara Etlik City Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 27, 2024

First Posted

May 1, 2024

Study Start

June 15, 2024

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 30, 2026

Record last verified: 2026-09

Locations