FrailtyNCT06393647
Relationship Between Albumin/Creatine Ratio, B12, Folate, and Frailty Index
An observational study of Frailty, run by Ankara Etlik City Hospital at 2 sites in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Frailty
- What is being tested?
- Frailty scale forms (Frailty Scale Version 9)
- How many people
- 80 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Jun 2024to 1 Dec 2026
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, 06170
Yusuf Ozguner, +903127970000, etliksh.iletisim@saglik.gov.tr
- Recruiting
Yusuf
Çankaya, Ankara
Yusuf Ozguner, 05427150725, y.ozguner@hotmail.com
About this study
Official title: Relationship Between Albumin/Creatine Ratio, B12, Folate, and Frailty Index in Patients Undergoing Gastrointestinal Malignancy Surgery
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.
Read the detailed description
Frailty is a condition associated with a decline in physiological performance. Patients are categorized as healthy, pre-frail, or frail based on physiological and functional characteristics. Frailty is known to be influenced by various lifestyle factors such as socioeconomic status, psychological factors, diet, exercise, and genetic predisposition. With aging, there is an increase in cognitive and physical dysfunction, which correlates with an increase in frailty. Along with frailty, geriatric symptoms, mortality, and other negative health outcomes also increase in the elderly population. Therefore, early detection of frailty is crucial to implementing lifestyle changes aimed at improving cognitive and physical status. Various assessment scales are used to evaluate frailty, such as the Frailty Scale Version 9.
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 form (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.
- Conditions
- Frailty
- Being tested
- Frailty scale forms (Frailty Scale Version 9)
- Keywords
- Frailty Scale, Albumin/Creatine Ratio, B12, Folate
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frailty scale forms (Frailty Scale Version 9)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Frailty scale forms (Frailty Scale Version 9) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: one day before surgery
Secondary outcomes (4)
Association between preoperative Clinical Frailty Scale (CFS) score and B12 levels
B12 concentration will be measured
Measured: one day before surgery
Association between preoperative Clinical Frailty Scale (CFS) score and Folate levels
Folate concentration will be measured
Measured: one day before surgery
Association between preoperative Clinical Frailty Scale (CFS) score and iron levels
Serum iron concentration will be measured.
Measured: one day before surgery
Association between preoperative Clinical Frailty Scale (CFS) score and Hemoglobin/RDW ratio.
Hemoglobin/RDW ratio will be measured.
Measured: one day before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start15 Jun 2024
- Primary completion15 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yusuf Özgüner, Ankara Etlik City Hospital
- Investigators
- Yusuf Ozguner, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393647
- Sponsor's protocol ID
- AnkaraEtlikYusufOzguner007
- Status last verified
- Sep 2026
- First submitted
- 27 Apr 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28140452Shamliyan 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.
PubMed 22426304
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Albumin/Creatine Ratio, B12, Folate, and Frailty Index in Patients Undergoing Gastrointestinal Malignancy Surgery
- ClinicalTrials.gov ID
- NCT06393647
- Acronym / sponsor ID
- AnkaraEtlikYusufOzguner007
- Conditions
- Frailty
- Keywords
- Frailty Scale, Albumin/Creatine Ratio, B12, Folate
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Frailty is a condition associated with a decline in physiological performance. Patients are categorized as healthy, pre-frail, or frail based on physiological and functional characteristics. Frailty is known to be influenced by various lifestyle factors such as socioeconomic status, psychological factors, diet, exercise, and genetic predisposition. With aging, there is an increase in cognitive and physical dysfunction, which correlates with an increase in frailty. Along with frailty, geriatric symptoms, mortality, and other negative health outcomes also increase in the elderly population. Therefore, early detection of frailty is crucial to implementing lifestyle changes aimed at improving cognitive and physical status. Various assessment scales are used to evaluate frailty, such as the Frailty Scale Version 9.
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 form (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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Undergoing gastrointestinal malignancy surgery | – | Other: Frailty scale forms (Frailty Scale Version 9)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. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frailty scale forms (Frailty Scale Version 9)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. | Other | Undergoing gastrointestinal malignancy surgery |
Primary outcome
Association between preoperative Clinical Frailty Scale (CFS) score and serum albumin-to-creatinine ratio
Time frame: one day before 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.(Association between preoperative Clinical Frailty Scale (CFS) score and serum albumin-to-creatinine ratio.)
4 secondary outcomes
Association between preoperative Clinical Frailty Scale (CFS) score and B12 levels
Time frame: one day before surgery
Association between preoperative Clinical Frailty Scale (CFS) score and Folate levels
Time frame: one day before surgery
Association between preoperative Clinical Frailty Scale (CFS) score and iron levels
Time frame: one day before surgery
Association between preoperative Clinical Frailty Scale (CFS) score and Hemoglobin/RDW ratio.
Time frame: one day before surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 28140452Kim 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.
- Results publication: PubMed 22426304Shamliyan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yusuf Ozguner principal investigator
Ankara Etlik City Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty, run by Ankara Etlik City Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yusuf Ozguner (05427150725, y.ozguner@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between preoperative Clinical Frailty Scale (CFS) score and serum albumin-to-creatinine ratio (time frame: one day before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06393647, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.