Clinical trial NCT05550701: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer Stage IV
Lymph Node Yield
Lead sponsor: The Second Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2022-09-22
Enrollment: 4575
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: cancer specific survival
timeFrame: 2010.01-2017.12
Secondary outcomes:
Other outcomes:
Locations:
city: Harbin
country: China
facility: Ethics and ethics of the Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
Study officials:
References:
citation: 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.
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.