Development and Validation of a Web-based Nomorgam to Pre... | NCT05301699

Studies
Development and Validation of a Web-based Nomorgam to Predict Postoperative Complications

NCT05301699

Sponsor

Nanjing Medical University

Status

Completed

Last Update Posted

Jun 1, 2022Actual

Enrollment

582Actual

Phase

Not provided

Conditions

Gastric Cancer

Interventions

data analysis; validating the nomogram

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Actual

Primary Completion Date

Mar 30, 2022Actual

Completion Date

Mar 30, 2022Actual

First Submitted Date

Mar 19, 2022

First Submission Date that Met QC Criteria

Mar 28, 2022

First Posted Date

Mar 31, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2022

Last Update Posted Date

Jun 1, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

582Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
data analysis; validating the nomogram	Other	Not Applicable. Our study did not involve intervention	training cohort validation cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postoperative complications during hospitalization	the investigators captured it from electronic medical records	about 3 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

received preoperative radiotherapy or chemotherapy
with other sites of malignant tumors

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

elderly gastric cancer patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanjing medical university		Nanjing			China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided