Colorectal CancerNCT06319404
Immune Function of Colorectal Cancer Lymph Nodes
An observational study of Colorectal Cancer and Lymph Node, run by Shanxi Province Cancer Hospital.
Trial summary
Lymph nodes are very important immune organs in the human body and play an important role in the physiological and pathological activities of the body, especially in anti-tumor immunity. The role of regional draining lymph nodes in the development of colorectal cancer is still unknown. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer, Lymph Node
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Apr 2026
- 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 75 years
- All sexes
- Adult, Older adult
Study population: Stage I-III colorectal cancer patients undergoing radical surgery with complete clinical imaging, pathology, and genetic data.
Who may be able to join
- Stage I-III colorectal cancer patients undergoing radical surgery
- Complete imaging, pathology and genetics multi-omics data available
- 18-75 years old
Who cannot join
- Patients with preoperative neoadjuvant therapy
- Patients with incomplete clinical information
- Patients with other malignant tumors
- Patients with acute infections or untreated chronic infections
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multiomics-based Study of the Immune Function of Colorectal Cancer Lymph Nodes
Lymph nodes are very important immune organs in the human body and play an important role in the physiological and pathological activities of the body, especially in anti-tumor immunity. The role of regional draining lymph nodes in the development of colorectal cancer is still unknown. In this study, the role of lymph nodes in the development of colorectal cancer was investigated through multicenter and multi-omics data.
- Conditions
- Colorectal Cancer, Lymph Node
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| negative lymph node | Not described | |
| postive lymph node | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the difference of immune pathway activation in tumor-draining lymph node based on genomics
BULK-RNA sequencing was performed on tumor draining lymph nodes to detect the activation of immune pathways in lymph nodes and explore the differences between them
Measured: 2024.04-2026.04
To investigate the relationship between the type and number of immune cells in tumor draining lymph nodes and the activation of immune pathways is based on pathomics
Multiple immunohistochemistry was used to identify the type and number of immune cells and to explore the relationship between the activation state of immune pathways
Measured: 2024.04-2026.04
The immune function of tumor draining lymph nodes of colorectal cancer patients was previously identified based on radiomics
Preoperative imaging data (CT, MRI) of patients were collected, and information in the images was extracted based on artificial intelligence algorithms. Predictive models were constructed to identify patients with good or bad immune function before surgery and guide subsequent treatment
Measured: 2024.04-2026.04
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanxi Province Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Harbin Medical University, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319404
- Sponsor's protocol ID
- 2022YFC2505700
- Status last verified
- Jan 2024
- First submitted
- 19 Jan 2024
- Last updated
- 20 Mar 2024
- 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 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiomics-based Study of the Immune Function of Colorectal Cancer Lymph Nodes
- ClinicalTrials.gov ID
- NCT06319404
- Acronym / sponsor ID
- 2022YFC2505700
- Conditions
- Colorectal Cancer, Lymph Node
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanxi Province Cancer HospitalUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Harbin Medical University, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 20 Mar 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.
Lymph nodes are very important immune organs in the human body and play an important role in the physiological and pathological activities of the body, especially in anti-tumor immunity. The role of regional draining lymph nodes in the development of colorectal cancer is still unknown. In this study, the role of lymph nodes in the development of colorectal cancer was investigated through multicenter and multi-omics data.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| negative lymph node | – | – |
| postive lymph node | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Stage I-III colorectal cancer patients undergoing radical surgery with complete clinical imaging, pathology, and genetic data.
Key inclusion criteria (3 listed)
- Stage I-III colorectal cancer patients undergoing radical surgery
- Complete imaging, pathology and genetics multi-omics data available
- 18-75 years old
Key exclusion criteria (4 listed)
- Patients with preoperative neoadjuvant therapy
- Patients with incomplete clinical information
- Patients with other malignant tumors
- Patients with acute infections or untreated chronic infections
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 |
|---|---|---|
| Other | negative lymph node, postive lymph node |
Primary outcome
To investigate the difference of immune pathway activation in tumor-draining lymph node based on genomics
Time frame: 2024.04-2026.04
BULK-RNA sequencing was performed on tumor draining lymph nodes to detect the activation of immune pathways in lymph nodes and explore the differences between them
To investigate the relationship between the type and number of immune cells in tumor draining lymph nodes and the activation of immune pathways is based on pathomics
Time frame: 2024.04-2026.04
Multiple immunohistochemistry was used to identify the type and number of immune cells and to explore the relationship between the activation state of immune pathways
The immune function of tumor draining lymph nodes of colorectal cancer patients was previously identified based on radiomics
Time frame: 2024.04-2026.04
Preoperative imaging data (CT, MRI) of patients were collected, and information in the images was extracted based on artificial intelligence algorithms. Predictive models were constructed to identify patients with good or bad immune function before surgery and guide subsequent treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Lymph Node, run by Shanxi Province Cancer 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 3 inclusion and 4 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 20 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xu Guan (13141307719, drguanxu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the difference of immune pathway activation in tumor-draining lymph node based on genomics (time frame: 2024.04-2026.04). The study lists 3 primary outcomes in all. 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 20 Mar 2024.