Early Colorectal CancerNCT07542171
Clinical Outcomes After Non-curative Endoscopic Resection in Early Colorectal Cancer: A Multicenter Study
An observational study of Early Colorectal Cancer and Non-curative Endoscopic Resection, run by Nanfang Hospital, Southern Medical University at 3 sites in China.
Trial summary
This multicenter study aims to evaluate clinical outcomes and optimize management strategies in patients with early colorectal cancer who undergo non-curative endoscopic resection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Early Colorectal Cancer, Non-curative Endoscopic Resection
- What is being tested?
- Additional Surgery and Surveillance
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 3 sitesChina
- Study dates
- 3 Sep 2025to 1 Dec 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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: This multicenter cohort study includes adult patients with early colorectal cancer who underwent non-curative endoscopic resection. Participants are stratified into additional surgery and surveillance groups based on post-resection management strategies. Comprehensive clinicopathological characteristics and follow-up data are collected to evaluate recurrence patterns, survival outcomes, and to develop and validate a risk prediction model.
Who may be able to join
- Age ≥18 years;
- Patients with early colorectal cancer confirmed by histopathology;
- Patients who underwent endoscopic resection (including EMR, ESD, or equivalent techniques);
- Pathological diagnosis indicating non-curative resection, defined by the presence of at least one of the following: positive resection margin, submucosal invasion depth >1000 μm, poor differentiation, lymphovascular invasion, perineural invasion, or high-grade tumor budding;
- Availability of complete clinicopathological and follow-up data;
- Patients managed with either additional surgery or surveillance after endoscopic resection.
Who cannot join
- Patients with synchronous advanced colorectal cancer or distant metastasis at baseline;
- History of other active malignancies;
- Patients with inflammatory bowel disease, familial adenomatous polyposis, or other hereditary colorectal cancer syndromes;
- Patients who received neoadjuvant therapy before endoscopic resection;
- Incomplete pathological data or missing key variables;
- Loss to follow-up or follow-up duration less than 6 months.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong
Aimin Li, 86-13580317630, lam0725@163.com
- Recruiting
The Second Affiliated Hospital of Guangzhou Medical University
Haizhu, Guangzhou, Guangdong
Yangzhi Xu MD, PhD, +86 13632392962, 23260163@qq.com
- Recruiting
Shenzhen Longgang District People's Hospital
Shenzhen, Guangdong
Li Xiang, +86 13590337916, shellyxiangli@163.com
About this study
This multicenter study aims to evaluate clinical outcomes and optimize management strategies in patients with early colorectal cancer who undergo non-curative endoscopic resection.
Patients with non-curative resection following endoscopic treatment will be enrolled across multiple centers and managed according to real-world clinical decisions, including additional surgery or surveillance. Baseline demographic, endoscopic, and pathological characteristics will be systematically collected.
Read more
The primary objective is to compare recurrence and survival outcomes between different management strategies. Secondary objectives include identifying prognostic factors associated with recurrence and developing a risk stratification model to guide individualized treatment decisions.
All participants will undergo standardized follow-up according to clinical guidelines. This study is expected to provide real-world evidence to refine risk assessment, reduce unnecessary surgery, and improve personalized management for patients with early colorectal cancer after non-curative endoscopic resection.
- Being tested
- Additional Surgery, Surveillance
- Keywords
- Early colorectal cancer, Non-curative resection
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional SurgeryProcedure or surgery
Additional surgical resection performed after non-curative endoscopic resection based on pathological risk factors and clinical indications.
SurveillanceOther
Active surveillance with regular endoscopic and imaging follow-up without additional surgical intervention.
| Study group | Role | What they receive |
|---|---|---|
| Additional Surgery | Patients who underwent additional surgical resection following non-curative endoscopic resection based on pathological risk factors and clinical decision-making. Receives: Procedure: Additional Surgery | |
| Surveillance | Patients managed with surveillance after non-curative endoscopic resection, including regular endoscopic and imaging follow-up without additional surgical intervention. Receives: Other: Surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-Free Survival
Measured: Up to 2 years
Secondary outcomes (1)
Association Between High-Risk Pathological Factors and Recurrence
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start3 Sep 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542171
- Sponsor's protocol ID
- NFEC-2025-405
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes After Non-curative Endoscopic Resection in Early Colorectal Cancer: A Multicenter Study
- ClinicalTrials.gov ID
- NCT07542171
- Acronym / sponsor ID
- NFEC-2025-405
- Keywords
- Early colorectal cancer, Non-curative resection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 21 Apr 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 multicenter study aims to evaluate clinical outcomes and optimize management strategies in patients with early colorectal cancer who undergo non-curative endoscopic resection.
Patients with non-curative resection following endoscopic treatment will be enrolled across multiple centers and managed according to real-world clinical decisions, including additional surgery or surveillance. Baseline demographic, endoscopic, and pathological characteristics will be systematically collected.
The primary objective is to compare recurrence and survival outcomes between different management strategies. Secondary objectives include identifying prognostic factors associated with recurrence and developing a risk stratification model to guide individualized treatment decisions.
All participants will undergo standardized follow-up according to clinical guidelines. This study is expected to provide real-world evidence to refine risk assessment, reduce unnecessary surgery, and improve personalized management for patients with early colorectal cancer after non-curative endoscopic resection.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Additional Surgery | – | Procedure: Additional SurgeryPatients who underwent additional surgical resection following non-curative endoscopic resection based on pathological risk factors and clinical decision-making. |
| Surveillance | – | Other: SurveillancePatients managed with surveillance after non-curative endoscopic resection, including regular endoscopic and imaging follow-up without additional surgical intervention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This multicenter cohort study includes adult patients with early colorectal cancer who underwent non-curative endoscopic resection. Participants are stratified into additional surgery and surveillance groups based on post-resection management strategies. Comprehensive clinicopathological characteristics and follow-up data are collected to evaluate recurrence patterns, survival outcomes, and to develop and validate a risk prediction model.
Key inclusion criteria (6 listed)
- Age ≥18 years;
- Patients with early colorectal cancer confirmed by histopathology;
- Patients who underwent endoscopic resection (including EMR, ESD, or equivalent techniques);
- Pathological diagnosis indicating non-curative resection, defined by the presence of at least one of the following: positive resection margin, submucosal invasion depth >1000 μm, poor differentiation, lymphovascular invasion, perineural invasion, or high-grade tumor budding;
- Availability of complete clinicopathological and follow-up data;
Key exclusion criteria (6 listed)
- Patients with synchronous advanced colorectal cancer or distant metastasis at baseline;
- History of other active malignancies;
- Patients with inflammatory bowel disease, familial adenomatous polyposis, or other hereditary colorectal cancer syndromes;
- Patients who received neoadjuvant therapy before endoscopic resection;
- Incomplete pathological data or missing key variables;
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 |
|---|---|---|
| Additional SurgeryAdditional surgical resection performed after non-curative endoscopic resection based on pathological risk factors and clinical indications. | Procedure or surgery | Additional Surgery |
| SurveillanceActive surveillance with regular endoscopic and imaging follow-up without additional surgical intervention. | Other | Surveillance |
Primary outcome
Recurrence-Free Survival
Time frame: Up to 2 years
1 secondary outcome
Association Between High-Risk Pathological Factors and Recurrence
Time frame: Up to 2 years
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 21 Apr 2026.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Colorectal Cancer and Non-curative Endoscopic Resection, run by Nanfang Hospital, Southern Medical University at 3 sites in China.
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 6 inclusion and 6 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 21 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 3 sites in China. 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 Aimin Li (86-13580317630, lam0725@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-Free Survival (time frame: Up to 2 years). 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 21 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.