Colorectal Cancer Stage IVNCT05550701
Prognostic Impact of Increased Lymph Node Yield in Colorectal Cancer Patients With Synchronous Distant Metastasis: a Population-based Study of the US Database and a Chinese Registry
An observational study of Colorectal Cancer Stage IV and Lymph Node Yield, run by The Second Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial summary
The National Quality Forum has endorsed at least 12 lymph node yield (LNY) as a surgical quality indicator in colorectal cancer (CRC), but the prognostic value of adequate lymphadenectomy has rarely been investigated for CRC patients with distant metastatic disease. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colorectal Cancer Stage IV, Lymph Node Yield
- What is being tested?
- lymph node yield
- How many people
- 4,575 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2021to 10 Jul 2022
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the US Surveillance, Epidemiology, and End Results (SEER) and a Chinese registry (from two Chinese tertiary centers: The Second Affiliated Hospital of Harbin Medical University and National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences \& Peking Union Medical College) between January 2010 and December 2017
Who may be able to join
- Data on CRC patients with synchronous liver metastasis (LM) undergo surgery for CRC, have data on number of LNs retrieved and their survival status was known
Who cannot join
- Patients were excluded if they did not undergo surgery for CRC, did not have data on number of LNs retrieved and their survival status was unknown
Trial locations and contacts
1 site in 1 country.
China1 site
Ethics and ethics of the Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
About this study
The National Quality Forum has endorsed at least 12 lymph node yield (LNY) as a surgical quality indicator in colorectal cancer (CRC), but the prognostic value of adequate lymphadenectomy has rarely been investigated for CRC patients with distant metastatic disease.
Read the detailed description
Data on CRC patients with synchronous liver metastasis (LM) were derived from the US Surveillance, Epidemiology, and End Results (SEER) and a Chinese registry (from two Chinese tertiary centers: The Second Affiliated Hospital of Harbin Medical University and National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences \& Peking Union Medical College) between January 2010 and December 2017. Individual level data on patients with incident CRC were consecutively collected in both registries. The primary tumor site was divided into three subsites according to International Classification of Diseases for Oncology (ICD-O-3) topography codes: proximal colon (C18.0, C18.1, C18.2, C18.3 and C18.4), distal colon (C18.5, C18.6, C18.7) and rectum (C19.9 and C20.9). The synchronous LM were identified by imaging or histopathological examinations. Synchronous LM refers to liver lesions found within 6 months after the diagnosis of primary CRC. Patients were excluded if they did not undergo surgery for CRC, did not have data on number of LNs retrieved and their survival status was unknown.
- Conditions
- Colorectal Cancer Stage IV, Lymph Node Yield
- Being tested
- lymph node yield
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lymph node yieldOther
We recorded the number of lymph nodes dissected during surgery in patients with colorectal cancer
| Study group | Role | What they receive |
|---|---|---|
| SEER database | Data on CRC patients with synchronous liver metastasis (LM) were derived from the US Surveillance, Epidemiology, and End Results (SEER) between January 2010 and December 2017. Receives: Other: lymph node yield | |
| Chinese cohort | Data on CRC patients with synchronous liver metastasis (LM) were derived from two Chinese tertiary centers: The Second Affiliated Hospital of Harbin Medical University and National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences \& Peking Union Medical College between January 2010 and December 2017. Receives: Other: lymph node yield |
What is being measured
The primary outcome is the main question the study is designed to answer.
cancer specific survival
The primary outcome was cancer specific survival (CSS), which was defined as the time interval from the synchronous LM diagnosis until cancer specific death or the end of follow-up in Chinese registry, and the CSS was defined using the SEER cause-of-death codes in SEER registry
Measured: 2010.01-2017.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start5 May 2021
- Primary completion30 May 2022
- Study completion10 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer Stage IVStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,575 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Shuai Jiao, The Second Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550701
- Sponsor's protocol ID
- SZSM201911012
- Status last verified
- Jul 2022
- First submitted
- 20 Sep 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data involves the relevant personal privacy information of the patient
Publications
Doll KM, Rademaker A, Sosa JA. Practical Guide to Surgical Data Sets: Surveillance, Epidemiology, and End Results (SEER) Database. JAMA Surg. 2018 Jun 1;153(6):588-589. doi: 10.1001/jamasurg.2018.0501. No abstract available.
PubMed 29617544Thomas L, Li F, Pencina M. Using Propensity Score Methods to Create Target Populations in Observational Clinical Research. JAMA. 2020 Feb 4;323(5):466-467. doi: 10.1001/jama.2019.21558. No abstract available.
PubMed 31922529Jiao S, Guan X, Zhang W, Wei R, Wang G, Wang X. Prognostic impact of increased lymph node yield in colorectal cancer patients with synchronous liver metastasis: a population-based retrospective study of the US database and a Chinese registry. Int J Surg. 2023 Jul 1;109(7):1932-1940. doi: 10.1097/JS9.0000000000000244.
PubMed 37037584
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Impact of Increased Lymph Node Yield in Colorectal Cancer Patients With Synchronous Distant Metastasis: a Population-based Study of the US Database and a Chinese Registry
- ClinicalTrials.gov ID
- NCT05550701
- Acronym / sponsor ID
- SZSM201911012
- Conditions
- Colorectal Cancer Stage IV, Lymph Node Yield
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,575 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 5 May 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 22 Sep 2022 (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 National Quality Forum has endorsed at least 12 lymph node yield (LNY) as a surgical quality indicator in colorectal cancer (CRC), but the prognostic value of adequate lymphadenectomy has rarely been investigated for CRC patients with distant metastatic disease.
Detailed description
Data on CRC patients with synchronous liver metastasis (LM) were derived from the US Surveillance, Epidemiology, and End Results (SEER) and a Chinese registry (from two Chinese tertiary centers: The Second Affiliated Hospital of Harbin Medical University and National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences \& Peking Union Medical College) between January 2010 and December 2017. Individual level data on patients with incident CRC were consecutively collected in both registries. The primary tumor site was divided into three subsites according to International Classification of Diseases for Oncology (ICD-O-3) topography codes: proximal colon (C18.0, C18.1, C18.2, C18.3 and C18.4), distal colon (C18.5, C18.6, C18.7) and rectum (C19.9 and C20.9). The synchronous LM were identified by imaging or histopathological examinations. Synchronous LM refers to liver lesions found within 6 months after the diagnosis of primary CRC. Patients were excluded if they did not undergo surgery for CRC, did not have data on number of LNs retrieved and their survival status was unknown.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SEER database | – | Other: lymph node yieldData on CRC patients with synchronous liver metastasis (LM) were derived from the US Surveillance, Epidemiology, and End Results (SEER) between January 2010 and December 2017. |
| Chinese cohort | – | Other: lymph node yieldData on CRC patients with synchronous liver metastasis (LM) were derived from two Chinese tertiary centers: The Second Affiliated Hospital of Harbin Medical University and National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences \& Peking Union Medical College between January 2010 and December 2017. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the US Surveillance, Epidemiology, and End Results (SEER) and a Chinese registry (from two Chinese tertiary centers: The Second Affiliated Hospital of Harbin Medical University and National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences \& Peking Union Medical College) between January 2010 and December 2017
Key inclusion criteria (1 listed)
- Data on CRC patients with synchronous liver metastasis (LM) undergo surgery for CRC, have data on number of LNs retrieved and their survival status was known
Key exclusion criteria (1 listed)
- Patients were excluded if they did not undergo surgery for CRC, did not have data on number of LNs retrieved and their survival status was unknown
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 |
|---|---|---|
| lymph node yieldWe recorded the number of lymph nodes dissected during surgery in patients with colorectal cancer | Other | Chinese cohort, SEER database |
Primary outcome
cancer specific survival
Time frame: 2010.01-2017.12
The primary outcome was cancer specific survival (CSS), which was defined as the time interval from the synchronous LM diagnosis until cancer specific death or the end of follow-up in Chinese registry, and the CSS was defined using the SEER cause-of-death codes in SEER registry
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 21 Dec 2022.
- Background: PubMed 29617544Doll KM, Rademaker A, Sosa JA. Practical Guide to Surgical Data Sets: Surveillance, Epidemiology, and End Results (SEER) Database. JAMA Surg. 2018 Jun 1;153(6):588-589. doi: 10.1001/jamasurg.2018.0501. No abstract available.
- Background: PubMed 31922529Thomas L, Li F, Pencina M. Using Propensity Score Methods to Create Target Populations in Observational Clinical Research. JAMA. 2020 Feb 4;323(5):466-467. doi: 10.1001/jama.2019.21558. No abstract available.
- Derived from this study: PubMed 37037584Jiao S, Guan X, Zhang W, Wei R, Wang G, Wang X. Prognostic impact of increased lymph node yield in colorectal cancer patients with synchronous liver metastasis: a population-based retrospective study of the US database and a Chinese registry. Int J Surg. 2023 Jul 1;109(7):1932-1940. doi: 10.1097/JS9.0000000000000244.
- Individual participant dataSharing planned: No. The data involves the relevant personal privacy information of the patient
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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 Stage IV and Lymph Node Yield, run by The Second Affiliated Hospital of Harbin Medical University 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 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 21 Dec 2022. 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?
cancer specific survival (time frame: 2010.01-2017.12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05550701, which also lists 3 linked publications.
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 21 Dec 2022.