Clinical trial NCT04820569: Long-term Heart-specific Mortality in the Presence of Competing Risks Among Patients With Non-metastatic Gastric Adenocarcinoma Undergoing Resection and Chemotherapy
Official title: Long-term Heart-specific Mortality in the Presence of Competing Risks Among Patients With Non-metastatic Gastric Adenocarcinoma Undergoing Resection and Chemotherapy A Population-based Cohort Study of 21,257 Cases, 2004-2016
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Long-term Heart-specific Mortality in the Presence of Competing Risks Among Patients With Gastric Adenocarcinoma Undergoing Resection and Chemotherapy
Lead sponsor: The First Affiliated Hospital of Anhui Medical University
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 21257
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases of non-metastatic gastric adenocarcinoma (nmGaC) were defined as patients with microscopically-confirmed first primary invasive adenocarcinoma of the stomach (International Classification of Diseases for Oncology, Third Edition (ICD-O-3) code: C16) without distant metastasis. Only those who underwent resection in January 2004 through December 2016 were included.

Brief summary: In this population-based cohort study, data on patients diagnosed with nmGaC in 2004 through 2016, managed with resection and chemotherapy, followed up until the end of 2016, and surviving ≥1 month were retrieved from the US Surveillance, Epidemiology, and End Results-18 Program. Cumulative mortality functions were calculated. Prognostic factors for heart-specific mortality were evaluated using both multivariable-adjusted Fine-Gray subdistribution and cause-specific hazard functions.


Eligibility criteria: Cases of non-metastatic gastric adenocarcinoma (nmGaC) were defined as patients with microscopically-confirmed first primary invasive adenocarcinoma of the stomach (International Classification of Diseases for Oncology, Third Edition (ICD-O-3) code: C16) without distant metastasis. Only those who underwent resection in January 2004 through December 2016 were included. Cancers of other histology types including squamous cell carcinoma, gastrointestinal stromal tumor or sarcoma, neuroendocrine tumor or carcinoid, lymphoma, and germ-cell tumor were ineligible, as were patients with non-gastric cancers involving the stomach, with benign or in situ tumors, or with other malignancies before gastric cancer. We further excluded patients with diagnosis based on death certificate only or autopsy, with missing follow-up period, survival status, or cause of death, or with unknown metastasis status. Cancers with distant metastasis were excluded since resection is not routinely recommended for them. Data before 2004 were not included, as the TNM stage information was unavailable. To minimize the effect of perioperative events on survival, we excluded patients surviving \<1 month. No restrictions were applied to age, and patients ≥80 years only comprised 5% of those receiving both resection and chemotherapy.

Primary outcomes:
measure: Cumulative mortality
timeFrame: Jan 12, 2020-Mar 5, 2021
measure: Prognostic factors for disease-specific mortalities
timeFrame: Jan 12, 2020-Mar 5, 2021
Secondary outcomes:
Other outcomes:
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