Colon CancerNCT07149623
Metastatic Lymph Node Distribution in the Ileum Mesentery of Cecal and Proximal Ascending Colon Cancer
An observational study of Colon Cancer, run by Peking Union Medical College Hospital.
Trial summary
Based on the above considerations, our team maintains that it is currently imperative to conduct a prospective multicenter registry study. This study would involve sectioning and submitting fresh surgical specimens from the ileum mesentery of patients undergoing radical resection for cecal cancer and proximal… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Experimental
- Type of treatment
- Surgery or procedure
- How many people
- 406 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Sep 2030
- How long will I take part?
- 3 Years
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with cecal cancer and proximal ascending colon cancer
Who may be able to join
- Age 18-80 years; ECOG performance status 0-2; Histologically confirmed colon adenocarcinoma; Surgical specimen confirming tumor location at: ileocecal valve orifice (cecal cancer), OR proximal ascending colon cancer with tumor ≤5 cm from ileocecal valve; Clinical stage: cT2-4aN0M0, OR cTanyN+M0; Patient and family members fully understand the study and voluntarily participate by signing informed consent
Who cannot join
- Synchronous or metachronous multiple primary colon cancers (Note: Synchronous: diagnosed within 6 months; Metachronous: diagnosed >6 months apart); Preoperative neoadjuvant therapy (chemotherapy, immunotherapy, or radiotherapy) that may cause tumor regression or downstaging; Patients undergoing salvage radical surgery after endoscopic 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: A Prospective Multicenter Observational Study on Metastatic Lymph Node Distribution of Ileum Mesentery in Cecal Cancer and Proximal Ascending Colon Cancer
Based on the above considerations, our team maintains that it is currently imperative to conduct a prospective multicenter registry study. This study would involve sectioning and submitting fresh surgical specimens from the ileum mesentery of patients undergoing radical resection for cecal cancer and proximal ascending colon cancer (right-sided colon cancer). The objectives are to: Clarify the distribution range of metastatic lymph nodes within the ileum mesentery; Conduct survival follow-up on enrolled patients; Provide reliable evidence-based medical evidence for the individualized determination of ileal resection margins.
- Conditions
- Colon Cancer
- Being tested
- Experimental
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalProcedure or surgery
sectioning and submitting fresh surgical specimens from the ileum mesentery
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Not described Receives: Procedure: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metastatic rate in mesenteric lymph nodes
Measured: 1 month after surgery
Secondary outcomes (3)
Distribution of metastatic lymph nodes in the mesentery
Measured: 1 month after surgery
3-year disease-free survival
Measured: 3 years after surgery
5-year overall survival
Measured: 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- 406 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XIAO Yi, MD, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149623
- Sponsor's protocol ID
- RELARC-02
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Observational Study on Metastatic Lymph Node Distribution of Ileum Mesentery in Cecal Cancer and Proximal Ascending Colon Cancer
- ClinicalTrials.gov ID
- NCT07149623
- Acronym / sponsor ID
- RELARC-02
- Conditions
- Colon Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 406 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 2 Sep 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.
Based on the above considerations, our team maintains that it is currently imperative to conduct a prospective multicenter registry study. This study would involve sectioning and submitting fresh surgical specimens from the ileum mesentery of patients undergoing radical resection for cecal cancer and proximal ascending colon cancer (right-sided colon cancer). The objectives are to: Clarify the distribution range of metastatic lymph nodes within the ileum mesentery; Conduct survival follow-up on enrolled patients; Provide reliable evidence-based medical evidence for the individualized determination of ileal resection margins.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | Procedure: Experimental |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with cecal cancer and proximal ascending colon cancer
Key inclusion criteria (1 listed)
- Age 18-80 years; ECOG performance status 0-2; Histologically confirmed colon adenocarcinoma; Surgical specimen confirming tumor location at: ileocecal valve orifice (cecal cancer), OR proximal ascending colon cancer with tumor ≤5 cm from ileocecal valve; Clinical stage: cT2-4aN0M0, OR cTanyN+M0; Patient and family members fully understand the study and voluntarily participate by signing informed consent
Key exclusion criteria (1 listed)
- Synchronous or metachronous multiple primary colon cancers (Note: Synchronous: diagnosed within 6 months; Metachronous: diagnosed >6 months apart); Preoperative neoadjuvant therapy (chemotherapy, immunotherapy, or radiotherapy) that may cause tumor regression or downstaging; Patients undergoing salvage radical surgery after endoscopic resection.
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 |
|---|---|---|
| Experimentalsectioning and submitting fresh surgical specimens from the ileum mesentery | Procedure or surgery | experimental group |
Primary outcome
Metastatic rate in mesenteric lymph nodes
Time frame: 1 month after surgery
3 secondary outcomes
Distribution of metastatic lymph nodes in the mesentery
Time frame: 1 month after surgery
3-year disease-free survival
Time frame: 3 years after surgery
5-year overall survival
Time frame: 5 years 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 2 Sep 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer, run by Peking Union Medical College Hospital.
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 1 inclusion and 1 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 2 Sep 2025. 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 Zhen Sun (86-18910598831, sunzhen39@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metastatic rate in mesenteric lymph nodes (time frame: 1 month 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 2 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.