Colorectal (Colon or Rectal) CancerPERIO-BIONCT07881133
Perioperative Biomarkers in Colorectal and Gastric Cancer Surgery
A study testing Perioperative Biomarker-Guided Monitoring in people with Colorectal (Colon or Rectal) Cancer and STOMACH NEOPLASM, run by Bucharest Emergency Hospital at 1 site in Romania.
Trial summary
This study aims to evaluate whether monitoring perioperative inflammatory and metabolic biomarkers can help identify postoperative complications early in adult patients undergoing colorectal or gastric cancer surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal (Colon or Rectal) Cancer, STOMACH NEOPLASM
- What is being tested?
- Perioperative Biomarker-Guided Monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteRomania
- Study dates
- 25 Feb 2026to Jan 2029
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 years or older.
- Patients diagnosed with colorectal or gastric cancer.
- Patients scheduled for elective abdominal oncologic surgery.
- Patients classified as ASA physical status II-IV.
- Patients who provide written informed consent to participate in the study.
Who cannot join
- Patients with known autoimmune or immunological diseases that may significantly influence inflammatory biomarker levels.
- Patients diagnosed with inflammatory bowel disease (IBD).
- Patients who refuse to participate or do not provide written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site, 1 recruiting
- Recruiting
Emergency Clinical Hospital Bucharest
Bucharest, Bucharest, 014461
Mihaela Buiuc, MD, Principal Investigator, +40746179776, mihaelabuiuc@yahoo.com
Mihaelabuiuc@yahoo.com
About this study
Official title: Temporal Profiles of Inflammatory Markers in General Oncologic Surgery
This study aims to evaluate whether monitoring perioperative inflammatory and metabolic biomarkers can help identify postoperative complications early in adult patients undergoing colorectal or gastric cancer surgery.
The study is a randomized controlled trial conducted at Bucharest Emergency Clinical Hospital, Romania. Participants are assigned to either an intervention group receiving enhanced recovery care (ERAS) combined with perioperative biomarker monitoring or a control group receiving standard postoperative care.
Read more
The biomarkers of interest include procalcitonin, lactate, and blood glucose. The study will examine their relationship with postoperative complications, particularly infections and anastomotic leakage.
Participants will be followed for 30 days after surgery to assess postoperative complications, hospital length of stay, readmissions, and mortality.
The findings may help improve postoperative monitoring and support earlier recognition of complications in patients undergoing cancer surgery.
Read the detailed description
Study Design and Objectives
This study is a prospective, single-center, randomized controlled trial conducted at Bucharest Emergency Clinical Hospital, Romania, involving adult patients undergoing surgery for colorectal or gastric cancer.
The primary objective is to investigate whether perioperative monitoring of inflammatory and metabolic biomarkers, integrated into postoperative care, can facilitate early identification of postoperative complications within 30 days after surgery.
Randomization and Study Groups
Eligible participants are randomly assigned to one of two study groups using stratified block randomization. Allocation is performed using sealed envelopes prepared independently of the investigator.
The intervention group receives perioperative care incorporating Enhanced Recovery After Surgery (ERAS) principles and structured biomarker monitoring.
The control group receives standard perioperative care without protocol-mandated postoperative biomarker monitoring.
Biomarker Assessment
The biomarkers evaluated include procalcitonin (PCT), blood lactate, and blood glucose.
Preoperative assessment includes lactate, blood glucose, and serum electrolytes.
Postoperative biomarker monitoring in the intervention group includes lactate and procalcitonin approximately 12 hours after surgery, followed by additional procalcitonin measurements on postoperative days 3, 5, and 7.
Procalcitonin is assessed using a point-of-care semi-quantitative method.
Clinical Outcomes
Patients are followed for 30 days after surgery to assess postoperative complications, including surgical site infections, anastomotic leakage, and other infectious or non-infectious complications.
Additional outcomes include postoperative mortality, hospital length of stay, and hospital readmissions.
Clinical and laboratory findings will be analyzed to explore associations between perioperative biomarker patterns and postoperative outcomes and to evaluate the potential clinical usefulness of biomarker-guided postoperative monitoring.
Ethical Considerations
The study was approved by the hospital's Ethics Committee (Approval No. 46148, dated October 27, 2025). Written informed consent is obtained from all participants before enrollment.
- Being tested
- Perioperative Biomarker-Guided Monitoring
- Keywords
- Procalcitonin, Lactate, Perioperative Hyperglycemia, Postoperative Complications, Anastomotic Leakage, Surgical Site Infection, Enhanced Recovery After Surgery, Biomarker Monitoring, Colorectal Surgery, Gastric Cancer Surgery
- Medical subject headings
- Colonic Neoplasms, Stomach Neoplasms, Postoperative Complications, Anastomotic Leak, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative Biomarker-Guided MonitoringDiagnostic test
Participants allocated to the experimental group will undergo perioperative biomarker monitoring integrated into an Enhanced Recovery After Surgery (ERAS) protocol.
Biomarker assessments will include preoperative blood lactate and glucose measurements, postoperative lactate and procalcitonin measurements at 12 hours, and additional procalcitonin assessments on postoperative days 3, 5, and 7.
Biomarker results will be evaluated alongside clinical findings to support postoperative monitoring and early recognition of complications, particularly infections and anastomotic leakage.
Participants will be followed for 30 days after surgery to assess postoperative complications, hospital length of stay, readmissions, and mortality.
| Study group | Role | What they receive |
|---|---|---|
| ERAS and Biomarker-Guided Monitoring | Experimental | Participants assigned to the intervention group will receive an Enhanced Recovery After Surgery (ERAS)-based perioperative care protocol combined with serial biomarker monitoring. Biomarkers include blood lactate, procalcitonin (PCT), and blood glucose. Postoperative lactate and PCT are assessed at 12 hours, with additional PCT measurements on postoperative days 3, 5, and 7. Biomarker results are evaluated alongside clinical findings to support early identification of postoperative complications, particularly infections and anastomotic leakage. Participants are followed for 30 days after surgery. Receives: Diagnostic Test: Perioperative Biomarker-Guided Monitoring |
| Standard Perioperative Care | No intervention | Participants assigned to the control group will receive standard perioperative care according to the hospital's routine clinical protocols for colorectal or gastric cancer surgery. Postoperative monitoring will be based on clinical assessment and routine laboratory investigations. No additional protocol-mandated serial procalcitonin or lactate measurements will be performed as part of the study intervention. Any laboratory investigations or treatments considered clinically necessary will remain available at the discretion of the treating physician. Participants will be followed for 30 days after surgery to assess postoperative complications, hospital length of stay, readmissions, and mortality. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive Performance of Perioperative Biomarkers for Postoperative Complications
The predictive performance of perioperative procalcitonin, lactate, and blood glucose levels for postoperative complications will be assessed using receiver operating characteristic (ROC) curve analysis and the area under the curve (AUC). Postoperative complications, including infections and anastomotic leakage, will be assessed within 30 days after surgery.
Measured: Up to 30 days after surgery.
Secondary outcomes (4)
Incidence of Postoperative Infections
Proportion of participants developing at least one clinically diagnosed postoperative infection, including surgical site infections and intra-abdominal infections, within 30 days after colorectal or gastric cancer surgery. The incidence will be compared between the intervention and control groups.
Measured: Up to 30 days after surgery
Incidence of Anastomotic Leakage
Proportion of participants developing clinically or radiologically confirmed anastomotic leakage following colorectal or gastric cancer surgery. The incidence of anastomotic leakage will be compared between the intervention and control groups.
Measured: Up to 30 days after surgery
Length of Hospital Stay
Duration of postoperative hospitalization, measured in days from the date of surgery to hospital discharge. The length of hospital stay will be compared between the intervention and control groups.
Measured: From the date of surgery until hospital discharge, assessed up to 30 days
30-Day All-Cause Mortality
Proportion of participants who die from any cause within 30 days after surgery. Mortality rates will be compared between the intervention and control groups.
Measured: Up to 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 posted19 Oct 2026
- Study start25 Feb 2026
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal (Colon or Rectal) 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, controlled, two-arm parallel-group study involving adult patients undergoing colorectal or gastric cancer surgery. Participants are allocated in a 1:1 ratio to an intervention group receiving an ERAS-based perioperative care strategy with biomarker-guided postoperative monitoring or a control group receiving standard perioperative care without protocol-mandated postoperative biomarker monitoring. Randomization is stratified and uses blocks of 10, with allocation concealment through sealed envelopes prepared independently. Participants are followed for 30 days after surgery to assess postoperative outcomes.
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bucharest Emergency Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mihaela Buiuc, Bucharest Emergency Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881133
- Sponsor's protocol ID
- BUIUC-PCT-2026-01
- Other IDs
- 46148/27.10.2025
- Acronym
- PERIO-BIO
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Profiles of Inflammatory Markers in General Oncologic Surgery
- ClinicalTrials.gov ID
- NCT07881133
- Acronym / sponsor ID
- PERIO-BIO / BUIUC-PCT-2026-01
- Keywords
- Procalcitonin, Lactate, Perioperative Hyperglycemia, Postoperative Complications, Anastomotic Leakage, Surgical Site Infection, Enhanced Recovery After Surgery, Biomarker Monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Bucharest Emergency HospitalUniversity, hospital or other
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 19 Oct 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 study aims to evaluate whether monitoring perioperative inflammatory and metabolic biomarkers can help identify postoperative complications early in adult patients undergoing colorectal or gastric cancer surgery.
The study is a randomized controlled trial conducted at Bucharest Emergency Clinical Hospital, Romania. Participants are assigned to either an intervention group receiving enhanced recovery care (ERAS) combined with perioperative biomarker monitoring or a control group receiving standard postoperative care.
The biomarkers of interest include procalcitonin, lactate, and blood glucose. The study will examine their relationship with postoperative complications, particularly infections and anastomotic leakage.
Participants will be followed for 30 days after surgery to assess postoperative complications, hospital length of stay, readmissions, and mortality.
The findings may help improve postoperative monitoring and support earlier recognition of complications in patients undergoing cancer surgery.
Detailed description
Study Design and Objectives
This study is a prospective, single-center, randomized controlled trial conducted at Bucharest Emergency Clinical Hospital, Romania, involving adult patients undergoing surgery for colorectal or gastric cancer.
The primary objective is to investigate whether perioperative monitoring of inflammatory and metabolic biomarkers, integrated into postoperative care, can facilitate early identification of postoperative complications within 30 days after surgery.
Randomization and Study Groups
Eligible participants are randomly assigned to one of two study groups using stratified block randomization. Allocation is performed using sealed envelopes prepared independently of the investigator.
The intervention group receives perioperative care incorporating Enhanced Recovery After Surgery (ERAS) principles and structured biomarker monitoring.
The control group receives standard perioperative care without protocol-mandated postoperative biomarker monitoring.
Biomarker Assessment
The biomarkers evaluated include procalcitonin (PCT), blood lactate, and blood glucose.
Preoperative assessment includes lactate, blood glucose, and serum electrolytes.
Postoperative biomarker monitoring in the intervention group includes lactate and procalcitonin approximately 12 hours after surgery, followed by additional procalcitonin measurements on postoperative days 3, 5, and 7.
Procalcitonin is assessed using a point-of-care semi-quantitative method.
Clinical Outcomes
Patients are followed for 30 days after surgery to assess postoperative complications, including surgical site infections, anastomotic leakage, and other infectious or non-infectious complications.
Additional outcomes include postoperative mortality, hospital length of stay, and hospital readmissions.
Clinical and laboratory findings will be analyzed to explore associations between perioperative biomarker patterns and postoperative outcomes and to evaluate the potential clinical usefulness of biomarker-guided postoperative monitoring.
Ethical Considerations
The study was approved by the hospital's Ethics Committee (Approval No. 46148, dated October 27, 2025). Written informed consent is obtained from all participants before enrollment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, controlled, two-arm parallel-group study involving adult patients undergoing colorectal or gastric cancer surgery. Participants are allocated in a 1:1 ratio to an intervention group receiving an ERAS-based perioperative care strategy with biomarker-guided postoperative monitoring or a control group receiving standard perioperative care without protocol-mandated postoperative biomarker monitoring. Randomization is stratified and uses blocks of 10, with allocation concealment through sealed envelopes prepared independently. Participants are followed for 30 days after surgery to assess postoperative outcomes.
| Arm | Type | Receives |
|---|---|---|
| ERAS and Biomarker-Guided Monitoring | Experimental | Diagnostic Test: Perioperative Biomarker-Guided MonitoringParticipants assigned to the intervention group will receive an Enhanced Recovery After Surgery (ERAS)-based perioperative care protocol combined with serial biomarker monitoring. Biomarkers include blood lactate, procalcitonin (PCT), and blood glucose. Postoperative lactate and PCT are assessed at 12 hours, with additional PCT measurements on postoperative days 3, 5, and 7. Biomarker results are evaluated alongside clinical findings to support early identification of postoperative complications, particularly infections and anastomotic leakage. Participants are followed for 30 days after surgery. |
| Standard Perioperative Care | No intervention | –Participants assigned to the control group will receive standard perioperative care according to the hospital's routine clinical protocols for colorectal or gastric cancer surgery. Postoperative monitoring will be based on clinical assessment and routine laboratory investigations. No additional protocol-mandated serial procalcitonin or lactate measurements will be performed as part of the study intervention. Any laboratory investigations or treatments considered clinically necessary will remain available at the discretion of the treating physician. Participants will be followed for 30 days after surgery to assess postoperative complications, hospital length of stay, readmissions, and mortality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients aged 18 years or older.
- Patients diagnosed with colorectal or gastric cancer.
- Patients scheduled for elective abdominal oncologic surgery.
- Patients classified as ASA physical status II-IV.
- Patients who provide written informed consent to participate in the study.
Key exclusion criteria (3 listed)
- Patients with known autoimmune or immunological diseases that may significantly influence inflammatory biomarker levels.
- Patients diagnosed with inflammatory bowel disease (IBD).
- Patients who refuse to participate or do not provide written informed consent.
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 |
|---|---|---|
| Perioperative Biomarker-Guided MonitoringParticipants allocated to the experimental group will undergo perioperative biomarker monitoring integrated into an Enhanced Recovery After Surgery (ERAS) protocol. Biomarker assessments will include preoperative blood lactate and glucose measurements, postoperative lactate and procalcitonin measurements at 12 hours, and additional procalcitonin assessments on postoperative days 3, 5, and 7. Biomarker results will be evaluated alongside clinical findings to support postoperative monitoring and early recognition of complications, particularly infections and anastomotic leakage. Participants will be followed for 30 days after surgery to assess postoperative complications, hospital length of stay, readmissions, and mortality. | Diagnostic test | ERAS and Biomarker-Guided Monitoring |
Primary outcome
Predictive Performance of Perioperative Biomarkers for Postoperative Complications
Time frame: Up to 30 days after surgery.
The predictive performance of perioperative procalcitonin, lactate, and blood glucose levels for postoperative complications will be assessed using receiver operating characteristic (ROC) curve analysis and the area under the curve (AUC). Postoperative complications, including infections and anastomotic leakage, will be assessed within 30 days after surgery.
4 secondary outcomes
Incidence of Postoperative Infections
Time frame: Up to 30 days after surgery
Incidence of Anastomotic Leakage
Time frame: Up to 30 days after surgery
Length of Hospital Stay
Time frame: From the date of surgery until hospital discharge, assessed up to 30 days
30-Day All-Cause Mortality
Time frame: Up to 30 days after 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 19 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perioperative Biomarker-Guided Monitoring in people with Colorectal (Colon or Rectal) Cancer and STOMACH NEOPLASM, run by Bucharest Emergency Hospital at 1 site in Romania.
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 5 inclusion and 3 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 19 Oct 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 Romania. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive Performance of Perioperative Biomarkers for Postoperative Complications (time frame: Up to 30 days after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2026.