NCT05620537

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
808

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

November 10, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 17, 2022

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2022

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

15 days

First QC Date

November 10, 2022

Last Update Submit

February 9, 2023

Conditions

Gastrointestinal Cancers - StomachGastrointestinal Cancers - ColorectalPrognosisSurvival AnalysisNutrition Assessment

Keywords

Gastrointestinal CancerNRS 2002Postoperative survivalNomogrammulticenter study

Outcome Measures

Primary Outcomes (1)

  • postoperative overall survival

    It is the time from the date of surgery to the end of follow-up or death.

    2022-02-01

Study Arms (1)

Gastrointestinal cancer patients cohort

Other: observation

Interventions

observationOTHER

There are no interventions.

Gastrointestinal cancer patients cohort

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • years old
  • postoperative pathological diagnosis of gastric or colorectal adenocarcinoma
  • underwent radical surgery
  • TNM stage ranged from stage I to stage III

You may not qualify if:

  • NRS 2002 or PG-SGA data was missing
  • pathological diagnosis of gastric stump cancer, cancer in situ, or pin-point cancer
  • in-hospital death or death within 30 days after surgery
  • preoperative neoadjuvant therapy
  • preoperative endoscopic surgery
  • the previous history of other malignant tumors
  • pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinling Hospital

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Xinying Wang, M.D.

    Jinling Hospital, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

November 10, 2022

First Posted

November 17, 2022

Study Start

November 10, 2022

Primary Completion

November 25, 2022

Study Completion

November 25, 2022

Last Updated

February 13, 2023

Record last verified: 2023-02

Locations

CN(1)