An observational study in Gastrointestinal Cancers - Stomach, Gastrointestinal Cancers - Colorectal and Prognosis, sponsored by Wang Xinying. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-02-13.
Sponsored by Wang Xinying · Observational
This multicenter retrospectively observational cohort study was conducted on participants with histologically confirmed gastric and colorectal cancer who underwent radical surgery in 11 medical centers in China from August 1, 2015, to June 31, 2018. Baseline clinicopathologic data and nutritional status assessments including Nutrition Risk Screening 2002 (NRS 2002) score and Patient-generated Subjective Global Assessment (PG-SGA) rating were collected. Variables will be screened using the least absolute shrinkage and selection operator (LASSO) regression model and Cox regression analysis. Internal and external validations will be performed via the receiver operating curve (ROC), the area under the curve (AUC), the concordance index (C-index), calibration plots, decision curve analysis (DCA), and Five folds cross-validation by 200 times.
Nutritional status assessments All the centers routinely perform nutritional status assessments on admission by the NRS 2002 and PG-SGA. We collected the NRS 2002 score and PG-SGA rating from the electronic medical record system.
3.1 NRS 2002 NRS 2002 was used to estimate nutritional risk, accounting for inadequate nutritional status (low, moderate, or severe) and illness severity (low, moderate, or severe), with a 70-year age adjustment. The NRS 2002 score ranges from 0 to 7. For the NRS 2002, we employed three categories: no nutritional risk (\<3), nutritional risk (3-4), and severe nutritional risk (≥5).
3.2 PG-SGA The PG-SGA, a nutritional status assessment tool based on the SGA, was developed exclusively for cancer patients. This includes self-evaluation by patients as well as evaluation by medical professionals. The seven components that make up the core content are weight, food intake, symptoms, functional ability, illness and its relationship to nutritional needs, metabolic demand (stress), and physical examination. The first four components were assessed by patients, while the final three were assessed by medical professionals. Physical examination was used to determine muscular exhaustion, subcutaneous fat thickness, and edema. Decreased mass and tone in temporal regions, deltoids, and quads indicated muscular exhaustion. The triceps and midaxillary lines at the level of the lower ribs were studied for subcutaneous fat depletion. Edema was checked on the ankles. Patients were categorized as well-nourished (A), moderately malnourished (B), or severely malnourished (C) based on the foregoing assessments.
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This study's enrollment of 808 is above the median of 200 across 168 observational studies indexed under Gastrointestinal Neoplasms.
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The participants are who with histologically confirmed gastric and colorectal cancer who underwent radical surgery in 11 medical centers in China from August 1, 2015, to June 31, 2018.
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Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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Other: observation
There are no interventions.
postoperative overall survival
It is the time from the date of surgery to the end of follow-up or death.
Time frame: 2022-02-01
Plan to share: Undecided — Data and analytic code will be made available upon request pending application and approval by the corresponding author.
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Ran from Nov 2022 to primary completion in Nov 2022, 0 months.
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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Wang Xinying