Octogenarian Patients With Non-metastatic Resectable Colorectal CancerNCT07903129
SGA-OCRC: Prediction of 90-Day Major Adverse Postoperative Outcomes in Octogenarians With Resectable Colorectal Cancer
An observational study of Octogenarian Patients With Non-metastatic Resectable Colorectal Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
Octogenarian patients with colorectal cancer are a growing population with substantial heterogeneity in frailty, functional reserve, nutritional status, and comorbidity. Chronological age alone does not adequately capture this variation in perioperative risk. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Octogenarian Patients With Non-metastatic Resectable Colorectal Cancer
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2027to Sep 2030
- How long will I take part?
- 3 Months
- 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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Eligible patients will be aged ≥80 years with newly diagnosed or highly suspected, non-metastatic, technically resectable colorectal cancer involving the colon or upper rectum (lower tumor margin ≥12 cm from the anal verge). Elective and expedited surgery will be eligible. Expedited surgery refers to resection after initial assessment or stabilization for tumor-related symptoms, including bowel obstruction, when immediate emergency surgery is not required. Patients requiring immediate emergency surgery for perforation, acute complete obstruction, bowel ischemia, or other life-threatening complications will be excluded. Other exclusion criteria will include previous colorectal or major abdominal surgery, metastatic disease, lower rectal cancer requiring neoadjuvant treatment, severe cognitive impairment without a reliable informant, or refusal.
Who may be able to join
- Aged ≥80 years
- Newly diagnosed or highly suspected, non-metastatic, technically resectable colorectal cancer involving the colon or upper rectum (lower tumor margin ≥12 cm from the anal verge)
- Eligible for elective or expedited surgery (expedited surgery refers to resection after initial assessment or stabilization for tumor-related symptoms, including bowel obstruction, when immediate emergency surgery is not required)
Who cannot join
- Requiring immediate emergency surgery for perforation, acute complete obstruction, bowel ischemia, or other life-threatening complications
- Previous colorectal or major abdominal surgery
- Metastatic disease
- Lower rectal cancer requiring neoadjuvant treatment
- Severe cognitive impairment without a reliable informant
- Patient refusal
- Withdrawal Criteria:
- Intraoperative exploration reveals metastatic disease or tumor involvement of major organs or vessels that precludes an R0 resection
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Simplified Geriatric Assessment-Based Prediction of 90-Day Major Adverse Postoperative Outcomes in Octogenarian Patients With Non-metastatic Resectable Colorectal Cancer: Protocol for a Prospective Multicenter Cohort Study (SGA-OCRC)
Octogenarian patients with colorectal cancer are a growing population with substantial heterogeneity in frailty, functional reserve, nutritional status, and comorbidity. Chronological age alone does not adequately capture this variation in perioperative risk. Although geriatric assessment has been increasingly incorporated into the care of older patients with cancer, comprehensive geriatric assessment can be difficult to implement routinely in colorectal surgical practice.
The SGA-OCRC study is a prospective, multicenter observational cohort study designed to address this gap. The investigators will evaluate whether a pragmatic simplified geriatric assessment provides prognostic information beyond conventional clinical, laboratory, and tumor-related risk factors in patients aged ≥80 years with non-metastatic, resectable colorectal cancer. The study will develop and internally validate a preoperative prediction model for 90-day major adverse postoperative outcomes using contemporary prediction-model methodology. Particular attention will be given to model calibration, clinical utility, and internal validation rather than predictor selection based solely on statistical significance.
- Keywords
- Octogenarians, colorectal cancer, geriatric assessment, postoperative complications, risk prediction model
- Medical subject headings
- Colorectal Neoplasms, Postoperative Complications
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 |
|---|---|---|
| Surgical Cohort | Patients who undergo curative-intent colorectal resection will form the primary analysis cohort | |
| Non-surgical Cohort | Patients who fail to receive surgical resection will form the primary analysis cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day major adverse postoperative outcomes (MAPO)
The primary outcome is 90-day major adverse postoperative outcomes (MAPO), defined as the occurrence of any of the following:
- Clavien-Dindo grade ≥III complication: a postoperative complication requiring surgical, endoscopic, or radiological intervention, or more intensive treatment for life-threatening complications.
- Unplanned ICU admission: an unexpected transfer to the intensive care unit for postoperative monitoring or organ support.
- Mechanical ventilation >48 h: the need for invasive mechanical ventilation for more than 48 hours after surgery.
- 30- or 90-day all-cause mortality: death from any cause within 30 or 90 days after surgery.
- Unplanned readmission within 90 days: an unexpected hospital admission within 90 days after discharge from the index hospitalization.
The primary composite outcome will be analyzed as a binary variable. Patients will be classified as having MAPO if at least one qualifying event occurs within 90 days after surgery.
Measured: 90 days after surgery
Secondary outcomes (4)
Major pulmonary complications
Major postoperative pulmonary complications (PPCs) will be defined as clinically significant pulmonary complications occurring within 90 days after surgery that require active treatment or substantial respiratory support. Definitions will be based on the European Perioperative Clinical Outcome (EPCO) recommendations and the Standardized Endpoints in Perioperative Medicine-Consensus for Perioperative Clinical Outcomes (StEP-COMPAC) recommendations.
Major PPCs will be analyzed as a binary outcome and reported as the number and proportion of patients who experience at least one qualifying event within 90 days after surgery. Each component will also be reported separately as the number and proportion of affected patients. Patients experiencing multiple pulmonary complications will be counted only once in the composite outcome.
Measured: 90 days after surgery
KDIGO-defined acute kidney injury
AKI severity will be classified as KDIGO Stage 1-3 according to the highest stage reached based on either serum creatinine or urine output criteria. Any AKI will be defined as KDIGO Stage 1-3, whereas moderate-to-severe AKI will be defined as KDIGO Stage 2-3. Stage 3 AKI will be recorded separately because of its clinical severity and potential need for renal replacement therapy.
AKI will be analyzed as a binary outcome, with any AKI (KDIGO Stage 1-3) reported as the number and proportion of affected patients, with a 95% CI. The numbers and proportions of patients in each KDIGO stage will also be reported. Moderate-to-severe AKI (Stages 2-3) and Stage 3 AKI will be summarized separately.
Measured: 90 days after surgery
Postoperative delirium
Postoperative delirium (POD) will be assessed using the 4 'A's Test (4AT). The 4AT is a brief, validated tool for detecting delirium in older hospitalized patients and has also been evaluated in postoperative settings. A score of ≥4 will be considered a positive delirium screen.
Patients will be assessed daily from postoperative day 1 through postoperative day seven or hospital discharge, whichever occurs first. Delirium will be defined as an acute and fluctuating disturbance in attention and awareness accompanied by an additional disturbance in cognition, consistent with established diagnostic criteria. Whenever feasible, patients with a positive 4AT screen (≥4) will undergo clinical confirmation by a trained investigator using DSM-5-based criteria.
The incidence of POD will be analyzed as a binary outcome and reported as the number and proportion of affected patients, with a 95% CI. Delirium duration will be summarized using the median and interquartile range (IQR), as appropriate.
Measured: 90 days after surgery
Anastomotic leakage
Anastomotic leakage (AL) will be defined according to the International Study Group of Rectal Cancer (ISREC) criteria as a defect in the intestinal wall at the anastomotic site, including the suture or staple line, resulting in communication between the intraluminal and extraluminal compartments. The diagnosis may be established by clinical, radiological, endoscopic, or operative findings.
Anastomotic leakage will be classified according to the ISREC grading system. Grade A leakage requires no change in clinical management; Grade B leakage requires active therapeutic intervention but can be managed without relaparotomy; and Grade C leakage requires relaparotomy.
The incidence of any AL (Grades A-C) will be analyzed as a binary outcome and reported as the number and proportion of affected patients, with a 95% CI. The numbers and proportions of patients with Grade A, B, and C leakage will be reported separately. Grade B and Grade C leakage will also be summarized separately to describe
Measured: 90 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 posted29 Oct 2026
- Study startJun 2027 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Octogenarian Patients With Non-metastatic Resectable Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- 1,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhanhuai Wang, Dr., Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903129
- Sponsor's protocol ID
- 2026-1065
- Status last verified
- Sep 2026
- First submitted
- 7 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplified Geriatric Assessment-Based Prediction of 90-Day Major Adverse Postoperative Outcomes in Octogenarian Patients With Non-metastatic Resectable Colorectal Cancer: Protocol for a Prospective Multicenter Cohort Study (SGA-OCRC)
- ClinicalTrials.gov ID
- NCT07903129
- Acronym / sponsor ID
- 2026-1065
- Keywords
- Octogenarians, colorectal cancer, geriatric assessment, postoperative complications, risk prediction model
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Jun 2027 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 29 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.
Octogenarian patients with colorectal cancer are a growing population with substantial heterogeneity in frailty, functional reserve, nutritional status, and comorbidity. Chronological age alone does not adequately capture this variation in perioperative risk. Although geriatric assessment has been increasingly incorporated into the care of older patients with cancer, comprehensive geriatric assessment can be difficult to implement routinely in colorectal surgical practice.
The SGA-OCRC study is a prospective, multicenter observational cohort study designed to address this gap. The investigators will evaluate whether a pragmatic simplified geriatric assessment provides prognostic information beyond conventional clinical, laboratory, and tumor-related risk factors in patients aged ≥80 years with non-metastatic, resectable colorectal cancer. The study will develop and internally validate a preoperative prediction model for 90-day major adverse postoperative outcomes using contemporary prediction-model methodology. Particular attention will be given to model calibration, clinical utility, and internal validation rather than predictor selection based solely on statistical significance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Cohort | – | –Patients who undergo curative-intent colorectal resection will form the primary analysis cohort |
| Non-surgical Cohort | – | –Patients who fail to receive surgical resection will form the primary analysis cohort |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Eligible patients will be aged ≥80 years with newly diagnosed or highly suspected, non-metastatic, technically resectable colorectal cancer involving the colon or upper rectum (lower tumor margin ≥12 cm from the anal verge). Elective and expedited surgery will be eligible. Expedited surgery refers to resection after initial assessment or stabilization for tumor-related symptoms, including bowel obstruction, when immediate emergency surgery is not required. Patients requiring immediate emergency surgery for perforation, acute complete obstruction, bowel ischemia, or other life-threatening complications will be excluded. Other exclusion criteria will include previous colorectal or major abdominal surgery, metastatic disease, lower rectal cancer requiring neoadjuvant treatment, severe cognitive impairment without a reliable informant, or refusal.
Key inclusion criteria (3 listed)
- Aged ≥80 years
- Newly diagnosed or highly suspected, non-metastatic, technically resectable colorectal cancer involving the colon or upper rectum (lower tumor margin ≥12 cm from the anal verge)
- Eligible for elective or expedited surgery (expedited surgery refers to resection after initial assessment or stabilization for tumor-related symptoms, including bowel obstruction, when immediate emergency surgery is not required)
Key exclusion criteria (8 listed)
- Requiring immediate emergency surgery for perforation, acute complete obstruction, bowel ischemia, or other life-threatening complications
- Previous colorectal or major abdominal surgery
- Metastatic disease
- Lower rectal cancer requiring neoadjuvant treatment
- Severe cognitive impairment without a reliable informant
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
90-day major adverse postoperative outcomes (MAPO)
Time frame: 90 days after surgery
The primary outcome is 90-day major adverse postoperative outcomes (MAPO), defined as the occurrence of any of the following: 1. Clavien-Dindo grade ≥III complication: a postoperative complication requiring surgical, endoscopic, or radiological intervention, or more intensive treatment for life-threatening complications. 2. Unplanned ICU admission: an unexpected transfer to the intensive care unit for postoperative monitoring or organ support. 3. Mechanical ventilation >48 h: the need for invasive mechanical ventilation for more than 48 hours after surgery. 4. 30- or 90-day all-cause mortality: death from any cause within 30 or 90 days after surgery. 5. Unplanned readmission within 90 days: an unexpected hospital admission within 90 days after discharge from the index hospitalization. The primary composite outcome will be analyzed as a binary variable. Patients will be classified as having MAPO if at least one qualifying event occurs within 90 days after surgery.
4 secondary outcomes
Major pulmonary complications
Time frame: 90 days after surgery
KDIGO-defined acute kidney injury
Time frame: 90 days after surgery
Postoperative delirium
Time frame: 90 days after surgery
Anastomotic leakage
Time frame: 90 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 29 Oct 2026.
- Individual participant dataSharing planned: Yes
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.
Zhanhuai Wang, Dr. study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Octogenarian Patients With Non-metastatic Resectable Colorectal Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 8 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Zhanhuai Wang, Dr. (+86 87783759, wangzhanhuai@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day major adverse postoperative outcomes (MAPO) (time frame: 90 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 29 Oct 2026.