InflammationNCT06135558
Clinical Significance of Marginal Acute Inflammation for Stage II Colon Cancer
An observational study of Inflammation and Colon Cancer, run by Sun Yat-sen University.
Trial summary
Marginal acute inflammation would make reporting the serosal involvement of tumors controversial. We aimed to investigate the clinical significance and explore the prognostic value of MAI for stage II localized colon cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammation, Colon Cancer
- What is being tested?
- MAI detection
- How many people
- 1,167 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2016to 30 Oct 2023
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: stage II colon cancer patients
Who may be able to join
- (1) colon cancer patients with the preoperative staging of stage I-III who lacked distant metastasis; (2) patients who underwent radical resection, with postoperative pathology confirmed as pT3-4N0M0; and (3) complete follow-up information
Who cannot join
- (1) patients who received neo-adjuvant therapy; (2) patients with multiple primary colorectal cancer; and (3) patients with a history of malignant tumors
About this study
Official title: Presence and Clinical Significance of Marginal Acute Inflammation for Stage II Colon Cancer
Marginal acute inflammation would make reporting the serosal involvement of tumors controversial. We aimed to investigate the clinical significance and explore the prognostic value of MAI for stage II localized colon cancer.
- Conditions
- Inflammation, Colon Cancer
- Being tested
- MAI detection
- Medical subject headings
- Inflammation, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAI detectionDiagnostic test
to detect the presence of marginal acute inflammation
| Study group | Role | What they receive |
|---|---|---|
| T3 | patient staged T3 without marginal acute inflammation Receives: Diagnostic Test: MAI detection | |
| MAI | patient with marginal acute inflammation Receives: Diagnostic Test: MAI detection | |
| T4 | patient staged T4 without marginal acute inflammation Receives: Diagnostic Test: MAI detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
disease free survival
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start30 Jan 2016
- Primary completion30 Dec 2022
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Retrospective
- Enrolment
- 1,167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135558
- Sponsor's protocol ID
- GIH-SYip32
- Status last verified
- Nov 2023
- First submitted
- 11 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presence and Clinical Significance of Marginal Acute Inflammation for Stage II Colon Cancer
- ClinicalTrials.gov ID
- NCT06135558
- Acronym / sponsor ID
- GIH-SYip32
- Conditions
- Inflammation, Colon Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,167 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 30 Jan 2016 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 18 Nov 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.
Marginal acute inflammation would make reporting the serosal involvement of tumors controversial. We aimed to investigate the clinical significance and explore the prognostic value of MAI for stage II localized colon cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T3 | – | Diagnostic Test: MAI detectionpatient staged T3 without marginal acute inflammation |
| MAI | – | Diagnostic Test: MAI detectionpatient with marginal acute inflammation |
| T4 | – | Diagnostic Test: MAI detectionpatient staged T4 without marginal acute inflammation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- stage II colon cancer patients
Key inclusion criteria (1 listed)
- (1) colon cancer patients with the preoperative staging of stage I-III who lacked distant metastasis; (2) patients who underwent radical resection, with postoperative pathology confirmed as pT3-4N0M0; and (3) complete follow-up information
Key exclusion criteria (1 listed)
- (1) patients who received neo-adjuvant therapy; (2) patients with multiple primary colorectal cancer; and (3) patients with a history of malignant 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 |
|---|---|---|
| MAI detectionto detect the presence of marginal acute inflammation | Diagnostic test | MAI, T3, T4 |
Primary outcome
DFS
Time frame: 5 year
disease free survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Undecided. upon reasonable request
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation and Colon Cancer, run by Sun Yat-sen University.
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: finished, as of the sponsor's last update on 18 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (time frame: 5 year). 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 18 Nov 2023.