Gastric CancerNCT07803159
Frailty, Immunonutrition, Surgery Type, and Biologic Recovery in Elderly Gastric Cancer
An observational study of Gastric Cancer and Gastric Adenocarcinoma, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational cohort study will evaluate the effects of multidimensional frailty phenotypes, immunonutritional status, and surgical approach on biological recovery in patients aged 60 years and older undergoing surgery for gastric cancer. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Gastric Cancer, Gastric Adenocarcinoma
- What is being tested?
- Laparoscopic Gastrectomy and Open Gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 328 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2026to Aug 2028
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of patients aged 60 years and older with gastric cancer who are scheduled for elective radical gastrectomy at the General Surgery Clinic of Kocaeli City Hospital. Eligible participants will be enrolled prospectively according to the predefined inclusion and exclusion criteria. A total of 328 participants are planned to be included.
Who may be able to join
- Age 60 years or older.
- Histopathological or endoscopic diagnosis of gastric cancer.
- Planned elective radical gastrectomy.
- Written informed consent to participate in the study.
Who cannot join
- Stage IV metastatic gastric cancer.
- Requirement for emergency surgery.
- Severe neurological or psychiatric disease preventing completion of cognitive testing.
- Incomplete clinical data.
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kocaeli City Hospital
Kocaeli, İZMİT
Adem Yuksel, Assoc.Prof., +90 505 345 52 59, drademyuksel@gmail.com
Adem Yuksel, Assoc.Prof.
About this study
Official title: The Effects of Multidimensional Frailty Phenotypes, Immunonutritional Status, and Surgical Approach on Biological Recovery in Elderly Patients Undergoing Gastric Cancer Surgery: A Prospective Observational Study
This prospective observational cohort study will evaluate the effects of multidimensional frailty phenotypes, immunonutritional status, and surgical approach on biological recovery in patients aged 60 years and older undergoing surgery for gastric cancer. Preoperative assessment will include physical and cognitive frailty, nutritional status, handgrip strength, and skeletal muscle characteristics on computed tomography. Patients will be followed prospectively during the perioperative period, including assessment of inflammatory markers, postoperative complications, delirium, hospital length of stay, and functional recovery. The study aims to determine whether multidimensional frailty and immunonutritional factors are associated with postoperative outcomes and whether surgical approach influences biological recovery in older patients with gastric cancer. A total of 328 patients are planned to be included at Kocaeli City Hospital.
Read the detailed description
This prospective, observational, analytical cohort study will be conducted at the General Surgery Clinic of Kocaeli City Hospital. The study will include patients aged 60 years and older who have gastric cancer and are scheduled for elective radical gastrectomy. A total of 328 patients are planned to be enrolled.
Preoperative assessment will include multidimensional frailty-related parameters, including the modified Frailty Index-11 (mFI-11), Montreal Cognitive Assessment (MoCA), handgrip strength, Nutritional Risk Screening 2002 (NRS-2002), Prognostic Nutritional Index (PNI), and skeletal muscle characteristics assessed on computed tomography at the L3 level. Baseline neutrophil-to-lymphocyte ratio (NLR) and C-reactive protein (CRP) levels will also be recorded.
Intraoperative data will include surgical approach, operative duration, and intraoperative blood loss. Postoperatively, NLR and CRP will be assessed on postoperative days 1, 3, and 5. Delirium will be evaluated using the Confusion Assessment Method (CAM). Postoperative complications will be recorded according to the Clavien-Dindo classification, together with hospital length of stay and handgrip strength before discharge.
The primary purpose of the study is to evaluate the association between multidimensional frailty phenotypes and postoperative outcomes and biological recovery in older patients undergoing gastric cancer surgery. The study will also investigate whether the surgical approach is associated with differences in biological recovery among patients with different frailty profiles.
- Conditions
- Gastric Cancer, Gastric Adenocarcinoma
- Being tested
- Laparoscopic Gastrectomy, Open Gastrectomy
- Keywords
- gastric cancer, fraility, immunonutrition, gastrectomy, cognitive function
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic GastrectomyProcedure or surgery
Elective radical gastrectomy performed using a laparoscopic approach as part of routine clinical care. The surgical approach is not assigned by the study
Open GastrectomyProcedure or surgery
Elective radical gastrectomy performed using an open approach as part of routine clinical care. The surgical approach is not assigned by the study
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Surgery | Patients undergoing elective radical gastrectomy through a laparoscopic approach. The surgical approach is determined by routine clinical practice and is not assigned by the study. Receives: Procedure: Laparoscopic Gastrectomy | |
| Open Surgery | Patients undergoing elective radical gastrectomy through an open approach. The surgical approach is determined by routine clinical practice and is not assigned by the study. Receives: Procedure: Open Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of postoperative complication
According to the Clavien-Dindo classification, the status of postoperative complications during index hospitalisation.
Measured: Up to 30 days post-operative
Secondary outcomes (1)
Comparison of Changes in the Neutrophil-to-Lymphocyte Ratio (NLR)
Change in neutrophil-to-lymphocyte ratio from preoperative baseline to postoperative days 1, 3, and 5
Measured: Preoperative baseline, day 1 post-operative, day 3 post-operative, day 5 post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Adem Yüksel, Kocaeli City Hospital
- Investigators
- Adem Yuksel, Assoc.Prof., Principal investigator, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803159
- Sponsor's protocol ID
- 2026-194
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data with other researchers.
Publications
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Japanese Gastric Cancer Association. Gastric cancer treatment guidelines 2021. Gastric Cancer. 2022;25:1-21.
Makary MA, Segev DL, Pronovost PJ, Syin D, Bandeen-Roche K, Patel P, Takenaga R, Devgan L, Holzmueller CG, Tian J, Fried LP. Frailty as a predictor of surgical outcomes in older patients. J Am Coll Surg. 2010 Jun;210(6):901-8. doi: 10.1016/j.jamcollsurg.2010.01.028. Epub 2010 Apr 28.
PubMed 20510798Ethun CG, Bilen MA, Jani AB, et al. Frailty and cancer surgery outcomes. Ann Surg Oncol. 2017;24:2131-2139.
McIsaac DI, Taljaard M, Bryson GL, Beaule PE, Gagne S, Hamilton G, Hladkowicz E, Huang A, Joanisse JA, Lavallee LT, MacDonald D, Moloo H, Thavorn K, van Walraven C, Yang H, Forster AJ. Frailty as a Predictor of Death or New Disability After Surgery: A Prospective Cohort Study. Ann Surg. 2020 Feb;271(2):283-289. doi: 10.1097/SLA.0000000000002967.
PubMed 30048320Shimada H, Makizako H, Lee S, Doi T, Lee S, Tsutsumimoto K, Harada K, Hotta R, Bae S, Nakakubo S, Harada K, Suzuki T. Impact of Cognitive Frailty on Daily Activities in Older Persons. J Nutr Health Aging. 2016;20(7):729-35. doi: 10.1007/s12603-016-0685-2.
PubMed 27499306Partridge JS, Harari D, Martin FC, Dhesi JK. The impact of pre-operative comprehensive geriatric assessment on postoperative outcomes in older patients undergoing scheduled surgery: a systematic review. Anaesthesia. 2014 Jan;69 Suppl 1:8-16. doi: 10.1111/anae.12494.
PubMed 24303856Jia G, Li K. Prognostic Nutritional Index is A Useful Predictive Marker for Morbidity and Mortality in Surgery for Perforated Peptic Ulcer. J Inflamm Res. 2025 Aug 14;18:11021-11028. doi: 10.2147/JIR.S519037. eCollection 2025.
PubMed 40831514Kanasaki H, Oride A, Miyazaki K. Laparoscopic surgery in elderly patients aged 65 years and older with gynecologic disease. ISRN Obstet Gynecol. 2012;2012:678201. doi: 10.5402/2012/678201. Epub 2012 Nov 21.
PubMed 23227353Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.
PubMed 23395245
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Multidimensional Frailty Phenotypes, Immunonutritional Status, and Surgical Approach on Biological Recovery in Elderly Patients Undergoing Gastric Cancer Surgery: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07803159
- Acronym / sponsor ID
- 2026-194
- Conditions
- Gastric Cancer, Gastric Adenocarcinoma
- Keywords
- gastric cancer, fraility, immunonutrition, gastrectomy, cognitive function
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 3 Sep 2026 (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.
This prospective observational cohort study will evaluate the effects of multidimensional frailty phenotypes, immunonutritional status, and surgical approach on biological recovery in patients aged 60 years and older undergoing surgery for gastric cancer. Preoperative assessment will include physical and cognitive frailty, nutritional status, handgrip strength, and skeletal muscle characteristics on computed tomography. Patients will be followed prospectively during the perioperative period, including assessment of inflammatory markers, postoperative complications, delirium, hospital length of stay, and functional recovery. The study aims to determine whether multidimensional frailty and immunonutritional factors are associated with postoperative outcomes and whether surgical approach influences biological recovery in older patients with gastric cancer. A total of 328 patients are planned to be included at Kocaeli City Hospital.
Detailed description
This prospective, observational, analytical cohort study will be conducted at the General Surgery Clinic of Kocaeli City Hospital. The study will include patients aged 60 years and older who have gastric cancer and are scheduled for elective radical gastrectomy. A total of 328 patients are planned to be enrolled.
Preoperative assessment will include multidimensional frailty-related parameters, including the modified Frailty Index-11 (mFI-11), Montreal Cognitive Assessment (MoCA), handgrip strength, Nutritional Risk Screening 2002 (NRS-2002), Prognostic Nutritional Index (PNI), and skeletal muscle characteristics assessed on computed tomography at the L3 level. Baseline neutrophil-to-lymphocyte ratio (NLR) and C-reactive protein (CRP) levels will also be recorded.
Intraoperative data will include surgical approach, operative duration, and intraoperative blood loss. Postoperatively, NLR and CRP will be assessed on postoperative days 1, 3, and 5. Delirium will be evaluated using the Confusion Assessment Method (CAM). Postoperative complications will be recorded according to the Clavien-Dindo classification, together with hospital length of stay and handgrip strength before discharge.
The primary purpose of the study is to evaluate the association between multidimensional frailty phenotypes and postoperative outcomes and biological recovery in older patients undergoing gastric cancer surgery. The study will also investigate whether the surgical approach is associated with differences in biological recovery among patients with different frailty profiles.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Surgery | – | Procedure: Laparoscopic GastrectomyPatients undergoing elective radical gastrectomy through a laparoscopic approach. The surgical approach is determined by routine clinical practice and is not assigned by the study. |
| Open Surgery | – | Procedure: Open GastrectomyPatients undergoing elective radical gastrectomy through an open approach. The surgical approach is determined by routine clinical practice and is not assigned by the study. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients aged 60 years and older with gastric cancer who are scheduled for elective radical gastrectomy at the General Surgery Clinic of Kocaeli City Hospital. Eligible participants will be enrolled prospectively according to the predefined inclusion and exclusion criteria. A total of 328 participants are planned to be included.
Key inclusion criteria (4 listed)
- Age 60 years or older.
- Histopathological or endoscopic diagnosis of gastric cancer.
- Planned elective radical gastrectomy.
- Written informed consent to participate in the study.
Key exclusion criteria (5 listed)
- Stage IV metastatic gastric cancer.
- Requirement for emergency surgery.
- Severe neurological or psychiatric disease preventing completion of cognitive testing.
- Incomplete clinical data.
- Refusal to participate in 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 |
|---|---|---|
| Laparoscopic GastrectomyElective radical gastrectomy performed using a laparoscopic approach as part of routine clinical care. The surgical approach is not assigned by the study | Procedure or surgery | Laparoscopic Surgery |
| Open GastrectomyElective radical gastrectomy performed using an open approach as part of routine clinical care. The surgical approach is not assigned by the study | Procedure or surgery | Open Surgery |
Primary outcome
Rate of postoperative complication
Time frame: Up to 30 days post-operative
According to the Clavien-Dindo classification, the status of postoperative complications during index hospitalisation.
1 secondary outcome
Comparison of Changes in the Neutrophil-to-Lymphocyte Ratio (NLR)
Time frame: Preoperative baseline, day 1 post-operative, day 3 post-operative, day 5 post-operative
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 3 Sep 2026.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- BackgroundJapanese Gastric Cancer Association. Gastric cancer treatment guidelines 2021. Gastric Cancer. 2022;25:1-21.
- Background: PubMed 20510798Makary MA, Segev DL, Pronovost PJ, Syin D, Bandeen-Roche K, Patel P, Takenaga R, Devgan L, Holzmueller CG, Tian J, Fried LP. Frailty as a predictor of surgical outcomes in older patients. J Am Coll Surg. 2010 Jun;210(6):901-8. doi: 10.1016/j.jamcollsurg.2010.01.028. Epub 2010 Apr 28.
- BackgroundEthun CG, Bilen MA, Jani AB, et al. Frailty and cancer surgery outcomes. Ann Surg Oncol. 2017;24:2131-2139.
- Background: PubMed 30048320McIsaac DI, Taljaard M, Bryson GL, Beaule PE, Gagne S, Hamilton G, Hladkowicz E, Huang A, Joanisse JA, Lavallee LT, MacDonald D, Moloo H, Thavorn K, van Walraven C, Yang H, Forster AJ. Frailty as a Predictor of Death or New Disability After Surgery: A Prospective Cohort Study. Ann Surg. 2020 Feb;271(2):283-289. doi: 10.1097/SLA.0000000000002967.
- Background: PubMed 27499306Shimada H, Makizako H, Lee S, Doi T, Lee S, Tsutsumimoto K, Harada K, Hotta R, Bae S, Nakakubo S, Harada K, Suzuki T. Impact of Cognitive Frailty on Daily Activities in Older Persons. J Nutr Health Aging. 2016;20(7):729-35. doi: 10.1007/s12603-016-0685-2.
- Background: PubMed 24303856Partridge JS, Harari D, Martin FC, Dhesi JK. The impact of pre-operative comprehensive geriatric assessment on postoperative outcomes in older patients undergoing scheduled surgery: a systematic review. Anaesthesia. 2014 Jan;69 Suppl 1:8-16. doi: 10.1111/anae.12494.
- Background: PubMed 40831514Jia G, Li K. Prognostic Nutritional Index is A Useful Predictive Marker for Morbidity and Mortality in Surgery for Perforated Peptic Ulcer. J Inflamm Res. 2025 Aug 14;18:11021-11028. doi: 10.2147/JIR.S519037. eCollection 2025.
- Background: PubMed 23227353Kanasaki H, Oride A, Miyazaki K. Laparoscopic surgery in elderly patients aged 65 years and older with gynecologic disease. ISRN Obstet Gynecol. 2012;2012:678201. doi: 10.5402/2012/678201. Epub 2012 Nov 21.
- Background: PubMed 23395245Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data with other researchers.
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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.
Adem Yuksel, Assoc.Prof. principal investigator
Kocaeli City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Gastric Adenocarcinoma, run by Kocaeli City Hospital at 1 site 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 3 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 1 site 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 Adem Yuksel, Assoc.Prof. (5053455259, drademyuksel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of postoperative complication (time frame: Up to 30 days post-operative). 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 NCT07803159, which also lists 10 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 3 Sep 2026.