NeoplasmsNCT06998030
Silent Threat: Impact of Preoperative Albumin Levels on Outcomes in Geriatric Cancer Surgery
An observational study of Neoplasms and Aged, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This retrospective, single-center study aims to evaluate the impact of preoperative albumin levels on postoperative outcomes in geriatric patients (aged 65 and above) undergoing cancer surgery. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neoplasms, Aged, Hypoalbuminemia
- How many people
- 330 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 10 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: This study will include geriatric patients aged 65 years and older who underwent elective cancer surgery at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital. All participants must have a documented preoperative serum albumin level. Patients with emergency or palliative surgery, active infection or inflammatory disease, or missing/incomplete medical records will be excluded. The study population represents a real-world cohort of elderly cancer patients at increased risk for postoperative complications due to age-related physiological changes and comorbidities.
Who may be able to join
- Age 65 years or older
- Diagnosed with cancer and underwent cancer surgery
- Preoperative albumin level recorded before surgery
Who cannot join
- Preoperative sepsis, severe infection, or active inflammatory disease
- Emergency or palliative surgery
- Missing preoperative albumin value
- Incomplete medical records or follow-up data
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation
Ankara, Yenimahalle, 06200
About this study
Official title: Silent Threat: How Do Preoperative Albumin Levels Affect Outcomes in Geriatric Cancer Surgery
This retrospective, single-center study aims to evaluate the impact of preoperative albumin levels on postoperative outcomes in geriatric patients (aged 65 and above) undergoing cancer surgery. The study will compare postoperative complication rates, length of hospital stay, and intensive care needs between patients with hypoalbuminemia and those with normal albumin levels.
Read the detailed description
Malnutrition is a significant risk factor for postoperative complications in elderly cancer patients. Preoperative serum albumin is a key biomarker reflecting nutritional and inflammatory status. This study will retrospectively review the medical records of 330 geriatric patients (≥65 years) who underwent cancer surgery at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital. Patients will be grouped according to preoperative albumin levels: Group 1 (<3.5 g/dL, hypoalbuminemia) and Group 2 (≥3.5 g/dL, normal). The primary aim is to compare postoperative complication rates, length of hospital stay, and intensive care requirements between these groups. The findings are expected to clarify the prognostic value of albumin and support individualized perioperative management in geriatric cancer surgery.
- Conditions
- Neoplasms, Aged, Hypoalbuminemia, Postoperative Complications, Malnutrition
- Medical subject headings
- Neoplasms, Hypoalbuminemia, Postoperative Complications, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (<3.5 g/dL, hypoalbuminemia) | Participants with preoperative serum albumin levels less than 3.5 g/dL. This group represents geriatric cancer surgery patients who are considered to have hypoalbuminemia, indicating poor nutritional and/or inflammatory status prior to surgery. | |
| Group 2 (≥3.5 g/dL, normal) | Participants with preoperative serum albumin levels equal to or greater than 3.5 g/dL. This group represents geriatric cancer surgery patients with normal preoperative albumin levels, reflecting adequate nutritional and inflammatory status prior to surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Complication Rate
The proportion of patients experiencing any postoperative complication (including but not limited to pulmonary complications, infections, or other adverse events) within 30 days after surgery, as assessed by clinical records and standardized criteria (e.g., Clavien-Dindo classification)
Measured: within 30 days after surgery
Secondary outcomes (5)
Length of Hospital Stay
Total number of days from the date of surgery to hospital discharge.
Measured: postoperative first 30 days
Postoperative Intensive Care Unit (ICU) Admission
The proportion of patients requiring ICU admission after surgery
Measured: immediately after the surgery
Length of ICU Stay
The total duration of ICU stay following surgery
Measured: 30 days after surgery
30-day Postoperative Mortality
All-cause mortality within 30 days after surgery
Measured: within 30 days after surgery
Incidence of Specific Postoperative Pulmonary Complications
The number of patients developing pulmonary complications (e.g., pneumonia, pleural effusion, atelectasis, ARDS, respiratory failure) within 30 days after surgery
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start1 Apr 2025
- Primary completion30 Apr 2025
- Study completion10 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies 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
- Retrospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Kemal ŞAHİN, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Investigators
- Mustafa Kemal SAHIN, Principal investigator, MUSTAFA KEMAL SAHİN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998030
- Sponsor's protocol ID
- 2025-03/53
- Status last verified
- Apr 2026
- First submitted
- 13 May 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Song S, Qiu P, Wang H, Zhang D, Qi Q, Feng L. Low preoperative serum prealbumin levels and risk of postoperative complications after transsphenoidal surgery in nonfunctioning pituitary adenoma. Neurosurg Focus. 2022 Dec;53(6):E6. doi: 10.3171/2022.9.FOCUS22211.
PubMed 36455266Caras RJ, Lustik MB, Kern SQ, McMann LP, Sterbis JR. Preoperative Albumin Is Predictive of Early Postoperative Morbidity and Mortality in Common Urologic Oncologic Surgeries. Clin Genitourin Cancer. 2017 Apr;15(2):e255-e262. doi: 10.1016/j.clgc.2016.09.008. Epub 2016 Sep 23.
PubMed 27765612Loftus TJ, Brown MP, Slish JH, Rosenthal MD. Serum Levels of Prealbumin and Albumin for Preoperative Risk Stratification. Nutr Clin Pract. 2019 Jun;34(3):340-348. doi: 10.1002/ncp.10271. Epub 2019 Mar 25.
PubMed 30908744Heise D, Bednarsch J, Kroh A, Schipper S, Eickhoff R, Lang S, Neumann U, Ulmer F. Operative Time, Age, and Serum Albumin Predict Surgical Morbidity After Laparoscopic Liver Surgery. Surg Innov. 2021 Dec;28(6):714-722. doi: 10.1177/1553350621991223. Epub 2021 Feb 10.
PubMed 33568020Sahin MK. Silent threat: how preoperative albumin levels affect geriatric cancer surgery outcomes? BMC Surg. 2026 Mar 16;26(1):292. doi: 10.1186/s12893-026-03659-9.
PubMed 41840567
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silent Threat: How Do Preoperative Albumin Levels Affect Outcomes in Geriatric Cancer Surgery
- ClinicalTrials.gov ID
- NCT06998030
- Acronym / sponsor ID
- 2025-03/53
- Conditions
- Neoplasms, Aged, Hypoalbuminemia, Postoperative Complications, Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 31 May 2025 (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 retrospective, single-center study aims to evaluate the impact of preoperative albumin levels on postoperative outcomes in geriatric patients (aged 65 and above) undergoing cancer surgery. The study will compare postoperative complication rates, length of hospital stay, and intensive care needs between patients with hypoalbuminemia and those with normal albumin levels.
Detailed description
Malnutrition is a significant risk factor for postoperative complications in elderly cancer patients. Preoperative serum albumin is a key biomarker reflecting nutritional and inflammatory status. This study will retrospectively review the medical records of 330 geriatric patients (≥65 years) who underwent cancer surgery at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital. Patients will be grouped according to preoperative albumin levels: Group 1 (<3.5 g/dL, hypoalbuminemia) and Group 2 (≥3.5 g/dL, normal). The primary aim is to compare postoperative complication rates, length of hospital stay, and intensive care requirements between these groups. The findings are expected to clarify the prognostic value of albumin and support individualized perioperative management in geriatric cancer surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (<3.5 g/dL, hypoalbuminemia) | – | –Participants with preoperative serum albumin levels less than 3.5 g/dL. This group represents geriatric cancer surgery patients who are considered to have hypoalbuminemia, indicating poor nutritional and/or inflammatory status prior to surgery. |
| Group 2 (≥3.5 g/dL, normal) | – | –Participants with preoperative serum albumin levels equal to or greater than 3.5 g/dL. This group represents geriatric cancer surgery patients with normal preoperative albumin levels, reflecting adequate nutritional and inflammatory status prior to surgery. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- This study will include geriatric patients aged 65 years and older who underwent elective cancer surgery at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital. All participants must have a documented preoperative serum albumin level. Patients with emergency or palliative surgery, active infection or inflammatory disease, or missing/incomplete medical records will be excluded. The study population represents a real-world cohort of elderly cancer patients at increased risk for postoperative complications due to age-related physiological changes and comorbidities.
Key inclusion criteria (3 listed)
- Age 65 years or older
- Diagnosed with cancer and underwent cancer surgery
- Preoperative albumin level recorded before surgery
Key exclusion criteria (4 listed)
- Preoperative sepsis, severe infection, or active inflammatory disease
- Emergency or palliative surgery
- Missing preoperative albumin value
- Incomplete medical records or follow-up data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative Complication Rate
Time frame: within 30 days after surgery
The proportion of patients experiencing any postoperative complication (including but not limited to pulmonary complications, infections, or other adverse events) within 30 days after surgery, as assessed by clinical records and standardized criteria (e.g., Clavien-Dindo classification)
5 secondary outcomes
Length of Hospital Stay
Time frame: postoperative first 30 days
Postoperative Intensive Care Unit (ICU) Admission
Time frame: immediately after the surgery
Length of ICU Stay
Time frame: 30 days after surgery
30-day Postoperative Mortality
Time frame: within 30 days after surgery
Incidence of Specific Postoperative Pulmonary Complications
Time frame: 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 36455266Song S, Qiu P, Wang H, Zhang D, Qi Q, Feng L. Low preoperative serum prealbumin levels and risk of postoperative complications after transsphenoidal surgery in nonfunctioning pituitary adenoma. Neurosurg Focus. 2022 Dec;53(6):E6. doi: 10.3171/2022.9.FOCUS22211.
- Background: PubMed 27765612Caras RJ, Lustik MB, Kern SQ, McMann LP, Sterbis JR. Preoperative Albumin Is Predictive of Early Postoperative Morbidity and Mortality in Common Urologic Oncologic Surgeries. Clin Genitourin Cancer. 2017 Apr;15(2):e255-e262. doi: 10.1016/j.clgc.2016.09.008. Epub 2016 Sep 23.
- Background: PubMed 30908744Loftus TJ, Brown MP, Slish JH, Rosenthal MD. Serum Levels of Prealbumin and Albumin for Preoperative Risk Stratification. Nutr Clin Pract. 2019 Jun;34(3):340-348. doi: 10.1002/ncp.10271. Epub 2019 Mar 25.
- Background: PubMed 33568020Heise D, Bednarsch J, Kroh A, Schipper S, Eickhoff R, Lang S, Neumann U, Ulmer F. Operative Time, Age, and Serum Albumin Predict Surgical Morbidity After Laparoscopic Liver Surgery. Surg Innov. 2021 Dec;28(6):714-722. doi: 10.1177/1553350621991223. Epub 2021 Feb 10.
- Derived from this study: PubMed 41840567Sahin MK. Silent threat: how preoperative albumin levels affect geriatric cancer surgery outcomes? BMC Surg. 2026 Mar 16;26(1):292. doi: 10.1186/s12893-026-03659-9.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mustafa Kemal SAHIN principal investigator
MUSTAFA KEMAL SAHİN
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 Neoplasms and Aged, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research 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 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: finished, as of the sponsor's last update on 30 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Complication Rate (time frame: within 30 days after 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 NCT06998030, which also lists 5 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 Apr 2026.