Colorectal CancerCNP-CRCNCT06783985
Clinical Application of Carbon Nanoparticles in Lymph Node Tracing and Surgery Guiding of Colorectal Cancer
An observational study of Colorectal Cancer, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
This trial aims to clarify the relationship between carbon nanoparticles labeled lymph nodes and lymph node metastasis in different lymph node regions of colorectal cancer, and to clarify the application value of carbon nanoparticles in lymph node dissection in colorectal cancer surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- Type of treatment
- Injection or infusion
- How many people
- 146 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2022to 20 Apr 2024
- How long will I take part?
- 1 Month
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study was conducted in Sir Run Run Shaw Hospital, Zhejiang University School of Medicine. Patient information and samples were obtained from patients undergoing radical resection of colorectal cancer in the colorectal surgery department of the hospital.
Who may be able to join
- a diagnosis of colorectal cancer;
- endoscopic injection of CNP suspension preoperatively
- planned radical resection of colorectal cancer
- older than 18 years of age
Who cannot join
- emergency surgery;
Trial locations and contacts
1 site in 1 country.
About this study
This trial aims to clarify the relationship between carbon nanoparticles labeled lymph nodes and lymph node metastasis in different lymph node regions of colorectal cancer, and to clarify the application value of carbon nanoparticles in lymph node dissection in colorectal cancer surgery.
- Conditions
- Colorectal Cancer
- Keywords
- carbon nanoparticle, 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.
| Study group | Role | What they receive |
|---|---|---|
| CNP group | Every patient received endoscopic injection of 0.5 ml CNP suspension (Chongqing LUMMY Pharmaceutical Co., Chongqing, China) into submucosal layer at one point, at the lower margin of the tumor. All patients subsequently underwent laparoscopic or robotic radical resection with D3 LN dissection. Tumor tissue and LNs s were isolated from surgical specimen by the same pathologist. LNs dissection and harvest were on the basis of the Japanese classification of colorectal carcinoma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between carbon nanoparticle stained lymph nodes and metastatic lymph nodes
Measured: From enrollment to the pathology report at 2 weeks
Secondary outcomes (1)
Carbon nanoparticle stained lymph nodes from different lymph node groups.
Measured: From enrollment to the pathology report at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start16 Mar 2022
- Primary completion20 Apr 2024
- Study completion20 Apr 2024
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.
- More trials run by Sir Run Run Shaw 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
- 146 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bingjun Bai, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783985
- Sponsor's protocol ID
- SirRRSH-CNP-CRC
- Acronym
- CNP-CRC
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Carbon Nanoparticles in Lymph Node Tracing and Surgery Guiding of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06783985
- Acronym / sponsor ID
- CNP-CRC / SirRRSH-CNP-CRC
- Conditions
- Colorectal Cancer
- Keywords
- carbon nanoparticle, colorectal cancer, lymph node
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 20 Apr 2024 (actual)
- Study completion
- 20 Apr 2024 (actual)
- First posted
- 20 Jan 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.
This trial aims to clarify the relationship between carbon nanoparticles labeled lymph nodes and lymph node metastasis in different lymph node regions of colorectal cancer, and to clarify the application value of carbon nanoparticles in lymph node dissection in colorectal cancer surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CNP group | – | –Every patient received endoscopic injection of 0.5 ml CNP suspension (Chongqing LUMMY Pharmaceutical Co., Chongqing, China) into submucosal layer at one point, at the lower margin of the tumor. All patients subsequently underwent laparoscopic or robotic radical resection with D3 LN dissection. Tumor tissue and LNs s were isolated from surgical specimen by the same pathologist. LNs dissection and harvest were on the basis of the Japanese classification of colorectal carcinoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study was conducted in Sir Run Run Shaw Hospital, Zhejiang University School of Medicine. Patient information and samples were obtained from patients undergoing radical resection of colorectal cancer in the colorectal surgery department of the hospital.
Key inclusion criteria (4 listed)
- a diagnosis of colorectal cancer;
- endoscopic injection of CNP suspension preoperatively
- planned radical resection of colorectal cancer
- older than 18 years of age
Key exclusion criteria (1 listed)
- emergency surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The relationship between carbon nanoparticle stained lymph nodes and metastatic lymph nodes
Time frame: From enrollment to the pathology report at 2 weeks
1 secondary outcome
Carbon nanoparticle stained lymph nodes from different lymph node groups.
Time frame: From enrollment to the pathology report at 2 weeks
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 20 Jan 2025.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Sir Run Run Shaw Hospital 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 4 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 20 Jan 2025. 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?
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?
The relationship between carbon nanoparticle stained lymph nodes and metastatic lymph nodes (time frame: From enrollment to the pathology report at 2 weeks). 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 Jan 2025.