Colorectal Neoplasms MalignantNCT06410729
Significance of Benign Lymph Node Enlargement in Colorectal Cancer
An observational study of Colorectal Neoplasms Malignant, run by Peking University Third Hospital.
Trial summary
The objective of this observational study was to investigate the clinical significance of benign mesenteric lymph node （BLNE） enlargement in patients with colorectal cancer. The main questions it aims to answer are: Do patients with benign mesenteric lymph node enlargement have a better prognosis? What are the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Neoplasms Malignant
- How many people
- 2,270 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 30 Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have undergone radical colorectal cancer surgery
Who may be able to join
- no regional lymph node metastasis or distant metastasis;
- stage I and II patients in the AJCC staging system;
- radical CRC resection achieving R0 status with no positive lymph nodes;
- a single malignant lesion confirmed via colonoscopy
Who cannot join
- underwent emergency surgery or had preoperative complications such as intestinal obstruction or perforation;
- had suspected distant metastasis on positron emission tomography (PET-CT);
- received preoperative neoadjuvant therapy;
- had hereditary CRC such as familial adenomatous polyposis;
- had microsatellite instability (MSI) confirmed by pathology.
- lacked imaging data;
- were lost to follow-up.
About this study
The objective of this observational study was to investigate the clinical significance of benign mesenteric lymph node （BLNE） enlargement in patients with colorectal cancer. The main questions it aims to answer are:
Do patients with benign mesenteric lymph node enlargement have a better prognosis? What are the clinical characteristics of benign mesenteric lymph node enlargement? As part of routine medical care for colorectal cancer, we will follow up with all participants over the course of the study.
Read the detailed description
From January 2015 to June 2023, 2,270 patients with colorectal cancer received surgical treatment at Peking University Third Hospital. The clinical data of these patients were recorded retrospectively and the eligible patients were divided into two groups. According to the 9th edition of the TNM staging System published by the AJCC, the BLNE group included the mesenteric BLNE group, while the non-benign lymph node enlargement (NBLNE) group was the control group. Inclusion criteria were :1) No regional lymph node metastasis or distant metastasis; 2) Stage I and II patients with AJCC staging system; 3) Radical CRC resection reached R0 status, no positive lymph nodes; Colonoscopy confirmed a single malignant lesion. Exclusion criteria :1) emergency surgery or preoperative complications such as intestinal obstruction and perforation; 2) Positron emission tomography (PET-CT) suspected distant metastasis; 3) Preoperative neoadjuvant therapy; 4) Hereditary colorectal cancer such as familial adenomatous polyposis; Microsatellite instability (MSI) was confirmed by pathology. In early colorectal cancer, MSI-H status is associated with a favorable prognosis and enhanced anti-tumor immune response. Therefore, we excluded these patients to avoid their influence on prognosis. 6) Lack of imaging data; 7) Loss of follow-up.
- Conditions
- Colorectal Neoplasms Malignant
- Being tested
- Observational study, no intervention
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study, no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Benign mesenteric lymph node enlargement (BLNE) | Lymph nodes with a diameter > 8 mm on preoperative imaging without metastasis on postoperative pathology were termed benign mesenteric lymph node enlargement. Receives: Other: Observational study, no intervention | |
| Non-benign mesenteric lymph node enlargement (NBLNE) | Lymph nodes with a diameter < 8 mm on preoperative imaging without metastasis on postoperative pathology were termed non-benign mesenteric lymph node enlargement. Receives: Other: Observational study, no intervention | |
| Metastatic mesenteric lymph node enlargement (MLNE) | Lymph nodes with a diameter > 8 mm on preoperative imaging with metastasis on postoperative pathology were termed metastatic mesenteric lymph node enlargement . Receives: Other: Observational study, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival of participants
From the time participants started undergoing radical surgery until their tumors returned or they died from tumor causes. The unit is month.
Measured: The time from the participants' first postoperative day to their last follow-up.
Secondary outcomes (1)
Overall survival of the participants
The time from the time participants began undergoing radical surgery until they died from any cause. Unit is month.
Measured: The time from the participants' first postoperative day to their last follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start1 Jan 2015
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Neoplasms MalignantStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Retrospective
- Enrolment
- 2,270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junwei Wang, M.D., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410729
- Sponsor's protocol ID
- IRB00006761-M2020123
- Status last verified
- Jun 2023
- First submitted
- 8 May 2024
- Last updated
- 14 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Significance of Benign Lymph Node Enlargement in Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06410729
- Acronym / sponsor ID
- IRB00006761-M2020123
- Conditions
- Colorectal Neoplasms Malignant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,270 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 13 May 2024 (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 objective of this observational study was to investigate the clinical significance of benign mesenteric lymph node （BLNE） enlargement in patients with colorectal cancer. The main questions it aims to answer are:
Do patients with benign mesenteric lymph node enlargement have a better prognosis? What are the clinical characteristics of benign mesenteric lymph node enlargement? As part of routine medical care for colorectal cancer, we will follow up with all participants over the course of the study.
Detailed description
From January 2015 to June 2023, 2,270 patients with colorectal cancer received surgical treatment at Peking University Third Hospital. The clinical data of these patients were recorded retrospectively and the eligible patients were divided into two groups. According to the 9th edition of the TNM staging System published by the AJCC, the BLNE group included the mesenteric BLNE group, while the non-benign lymph node enlargement (NBLNE) group was the control group. Inclusion criteria were :1) No regional lymph node metastasis or distant metastasis; 2) Stage I and II patients with AJCC staging system; 3) Radical CRC resection reached R0 status, no positive lymph nodes; Colonoscopy confirmed a single malignant lesion. Exclusion criteria :1) emergency surgery or preoperative complications such as intestinal obstruction and perforation; 2) Positron emission tomography (PET-CT) suspected distant metastasis; 3) Preoperative neoadjuvant therapy; 4) Hereditary colorectal cancer such as familial adenomatous polyposis; Microsatellite instability (MSI) was confirmed by pathology. In early colorectal cancer, MSI-H status is associated with a favorable prognosis and enhanced anti-tumor immune response. Therefore, we excluded these patients to avoid their influence on prognosis. 6) Lack of imaging data; 7) Loss of follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Benign mesenteric lymph node enlargement (BLNE) | – | Other: Observational study, no interventionLymph nodes with a diameter > 8 mm on preoperative imaging without metastasis on postoperative pathology were termed benign mesenteric lymph node enlargement. |
| Non-benign mesenteric lymph node enlargement (NBLNE) | – | Other: Observational study, no interventionLymph nodes with a diameter < 8 mm on preoperative imaging without metastasis on postoperative pathology were termed non-benign mesenteric lymph node enlargement. |
| Metastatic mesenteric lymph node enlargement (MLNE) | – | Other: Observational study, no interventionLymph nodes with a diameter > 8 mm on preoperative imaging with metastasis on postoperative pathology were termed metastatic mesenteric lymph node enlargement . |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have undergone radical colorectal cancer surgery
Key inclusion criteria (4 listed)
- no regional lymph node metastasis or distant metastasis;
- stage I and II patients in the AJCC staging system;
- radical CRC resection achieving R0 status with no positive lymph nodes;
- a single malignant lesion confirmed via colonoscopy
Key exclusion criteria (7 listed)
- underwent emergency surgery or had preoperative complications such as intestinal obstruction or perforation;
- had suspected distant metastasis on positron emission tomography (PET-CT);
- received preoperative neoadjuvant therapy;
- had hereditary CRC such as familial adenomatous polyposis;
- had microsatellite instability (MSI) confirmed by pathology.
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 |
|---|---|---|
| Observational study, no intervention | Other | Benign mesenteric lymph node enlargement (BLNE), Metastatic mesenteric lymph node enlargement (MLNE), Non-benign mesenteric lymph node enlargement (NBLNE) |
Primary outcome
Disease-free survival of participants
Time frame: The time from the participants' first postoperative day to their last follow-up.
From the time participants started undergoing radical surgery until their tumors returned or they died from tumor causes. The unit is month.
1 secondary outcome
Overall survival of the participants
Time frame: The time from the participants' first postoperative day to their last follow-up.
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 14 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
Junwei Wang, M.D. principal investigator
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms Malignant, run by Peking University Third 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 4 inclusion and 7 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 14 May 2024. 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?
Disease-free survival of participants (time frame: The time from the participants' first postoperative day to their last follow-up.). 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 14 May 2024.