Colon CancerNCT05859581
The Value of MRI in Assessing the Status of Retroperitoneal Resection Margin in Colon Cancer
A study testing Beyond complete mesocolic excision surgery in people with Colon Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
The goal of this clinical trial is to explore the value of colon MRI in assessing the status of retroperitoneal resection margin (RPRM) for advanced colon cancer. The main questions it aims to answer are: Concordance between MRI suspected RPRM positive and pathologically confirmed positive. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Beyond complete mesocolic excision surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2023to 31 Aug 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary colon adenocarcinoma confirmed by biopsy
- preoperative CT suspecting retroperitoneal resection margin (RPRM) positive
- received colon MRI scan
- underwent beyond complete mesocolic excision surgery
- sufficient clinical and pathological results
Who cannot join
- combined with other malignant tumors
- simultaneous distant metastasis
- definite invaded other organs or structures (T4b tumors)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Zhen Guan, MD, 861088196825, 18801231091@163.com
About this study
Official title: To Explore the Value of Colon MRI in Assessing the Status of Retroperitoneal Resection Margin Following Beyond Complete Mesocolic Excision Surgery for Advanced Colon Cancer
The goal of this clinical trial is to explore the value of colon MRI in assessing the status of retroperitoneal resection margin (RPRM) for advanced colon cancer.
The main questions it aims to answer are:
- Concordance between MRI suspected RPRM positive and pathologically confirmed positive.
- Can RPRM-positive patients undergo beyond complete mesocolic excision (CME) surgery in order to achieve R0 resection?
Participants will undergo colon MRI examination and once MRI suspects RPRM positive, they will receive beyond CME surgery.
- Conditions
- Colon Cancer
- Being tested
- Beyond complete mesocolic excision surgery
- Keywords
- Colon cancer, MRI, Resection margin
- Medical subject headings
- Colonic Neoplasms, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beyond complete mesocolic excision surgeryProcedure or surgery
If the participants were diagnosed with positive retroperitoneal resection margin (RPRM), they underwent beyond complete mesocolic excision surgery to ensure the R0 resection.
| Study group | Role | What they receive |
|---|---|---|
| Suspected positive RPRM on MRI | Experimental | Not described Receives: Procedure: Beyond complete mesocolic excision surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coincidence rate with pathological result
Coincidence rate between MRI diagnosed retroperitoneal resection margin and pathologically confirmed positive
Measured: within 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start2 Apr 2023
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (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 University Cancer Hospital & InstituteThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying-Shi Sun, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859581
- Sponsor's protocol ID
- Colon MRI-2023-01
- Status last verified
- May 2023
- First submitted
- 5 May 2023
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- 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 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Value of Colon MRI in Assessing the Status of Retroperitoneal Resection Margin Following Beyond Complete Mesocolic Excision Surgery for Advanced Colon Cancer
- ClinicalTrials.gov ID
- NCT05859581
- Acronym / sponsor ID
- Colon MRI-2023-01
- Conditions
- Colon Cancer
- Keywords
- Colon cancer, MRI, Resection margin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 2 Apr 2023 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 16 May 2023 (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.
The goal of this clinical trial is to explore the value of colon MRI in assessing the status of retroperitoneal resection margin (RPRM) for advanced colon cancer.
The main questions it aims to answer are:
- Concordance between MRI suspected RPRM positive and pathologically confirmed positive.
- Can RPRM-positive patients undergo beyond complete mesocolic excision (CME) surgery in order to achieve R0 resection?
Participants will undergo colon MRI examination and once MRI suspects RPRM positive, they will receive beyond CME surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected positive RPRM on MRI | Experimental | Procedure: Beyond complete mesocolic excision surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- primary colon adenocarcinoma confirmed by biopsy
- preoperative CT suspecting retroperitoneal resection margin (RPRM) positive
- received colon MRI scan
- underwent beyond complete mesocolic excision surgery
- sufficient clinical and pathological results
Key exclusion criteria (3 listed)
- combined with other malignant tumors
- simultaneous distant metastasis
- definite invaded other organs or structures (T4b tumors)
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 |
|---|---|---|
| Beyond complete mesocolic excision surgeryIf the participants were diagnosed with positive retroperitoneal resection margin (RPRM), they underwent beyond complete mesocolic excision surgery to ensure the R0 resection. | Procedure or surgery | Suspected positive RPRM on MRI |
Primary outcome
Coincidence rate with pathological result
Time frame: within 2 weeks after surgery
Coincidence rate between MRI diagnosed retroperitoneal resection margin and pathologically confirmed positive
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- 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.
Ying-Shi Sun, MD principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beyond complete mesocolic excision surgery in people with Colon Cancer, run by Peking University Cancer Hospital & Institute at 1 site 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 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: status not confirmed, as of the sponsor's last update on 16 May 2023. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhen Guan, MD (861088196825, 18801231091@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coincidence rate with pathological result (time frame: within 2 weeks 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 16 May 2023.