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

Colorectal Cancer Stage IV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05550701
• Other study ID #: SZSM201911012
• Status: Completed
• Start date: May 5, 2021
• Est. completion date: July 10, 2022

Study information

• Verified date: July 2022
• Source: The Second Affiliated Hospital of Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4575
• Est. completion date: July 10, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Colorectal Cancer Stage IV
• Colorectal Neoplasms

Intervention

Other:
• lymph node yield
We recorded the number of lymph nodes dissected during surgery in patients with colorectal cancer

Locations

Country	Name	City	State
China	Ethics and ethics of the Second Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang

Sponsors (2)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Harbin Medical University	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

Thomas 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2010.01-2017.12