NCT05301699

Brief Summary

The incidence of complications after gastrectomy remains high among elderly patients with gastric cancer. The investigators sought to establish and validate a web-based nomorgam for predicting total complications among elderly patients undergoing resection of gastric cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
582

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

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

Study Start

First participant enrolled

March 1, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 19, 2022

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

1.1 years

First QC Date

March 19, 2022

Last Update Submit

May 26, 2022

Conditions

Keywords

gastric cancer;postoperative complications;nomogram

Outcome Measures

Primary Outcomes (1)

  • postoperative complications during hospitalization

    the investigators captured it from electronic medical records

    about 3 weeks

Study Arms (2)

training cohort

The training cohort was used for data analysis.

Other: data analysis; validating the nomogram

validation cohort

The validation cohort was used for validating the nomogram

Other: data analysis; validating the nomogram

Interventions

Not Applicable. Our study did not involve intervention

training cohortvalidation cohort

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

elderly gastric cancer patients

You may qualify if:

  • diagnosed with gastric cancer by endoscopy or pathology
  • planned to receive radical surgery for the first time
  • aged 60 or older

You may not qualify if:

  • received preoperative radiotherapy or chemotherapy
  • with other sites of malignant tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing medical university

Nanjing, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 19, 2022

First Posted

March 31, 2022

Study Start

March 1, 2021

Primary Completion

March 30, 2022

Study Completion

March 30, 2022

Last Updated

June 1, 2022

Record last verified: 2022-05

Locations