Effectiveness of Managing Suspected Metastasis and Progre... | NCT04953585

Studies
Effectiveness of Managing Suspected Metastasis and Progress Using Plasma D-dimer Testing in Gastric Cancer Patients

NCT04953585

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Status

Completed

Last Update Posted

Jul 8, 2021Actual

Enrollment

1,000Actual

Phase

Not provided

Conditions

Stomach Neoplasms

Interventions

radical gastrectomy

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

Jan 2021

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

Jan 1, 2019Actual

Primary Completion Date

Jan 1, 2019Actual

Completion Date

Jan 1, 2021Actual

First Submitted Date

Jun 15, 2021

First Submission Date that Met QC Criteria

Jul 7, 2021

First Posted Date

Jul 8, 2021Actual

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

Jul 7, 2021

Last Update Posted Date

Jul 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

For prognosis evaluation, investigators enroll gastric cancer patients who underwent radical gastrectomy and collect the laboratory examination and clinicopathological characteristics. Then independent risk factors for overall survival will be analysed. For predicting efficacy evaluation, investigators also collect information of patients first diagnosed with metastases. Diagnostic efficacy is analysed by receiver operator characteristic curve method.

Detailed Description

To investigate the novel predictive value of coagulation factors for postoperative outcomes after radical gastrectomy in patients with gastric cancer, investigators enroll patients with a pathologically confirmed diagnosis of gastric cancer who underwent radical gastrectomy between January 2021 and february 2017. Patients follow up data were obtained by regular follow-up. The most recent preoperative laboratory tests and clinicopathological characteristics were evaluated. Patients are devided into two groups according to our target indicator. The 5-year overall survival rate is analysed by Kaplan-Meier method. The independent risk factors for overall survival are analysed by Cox proportional hazard regression method. Investigators hypothesized that the target factor is closely related to disease progression. Whether it can be used as a tumor marker to predict metastasis is to be studied. Investigators collect laboratory examination including tumor markers of patients first diagnosed with metastases. Diagnostic efficacy is analysed and compared by receiver operator characteristic curve method.

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

Retention

Enrollment

1,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal D-dimer group		preoperative plasma D-dimer levels less than or equal to 1mg/L	Procedure: radical gastrectomy
Elevated D-dimer group		preoperative plasma D-dimer levels greater than 1mg/L	Procedure: radical gastrectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
radical gastrectomy	Procedure	According to the size and location of the tumor, the appropriate surgical method was selected for radical gastrectomy	Elevated D-dimer group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
overall survival time	From date of radical gastrectomy until the date of last follow-up or date of death from gastric cancer, whichever came first, assessed up to 48 months	From date of radical gastrectomy until the date of last follow-up or date of death from gastric cancer, whichever came first, assessed up to 48 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients were newly diagnosed with gastric cancer;
all patients were pathologically diagnosed;
all patients had pre-treatment coagulation test;
stage I-IV disease;
age≥18 years

Exclusion Criteria:

accompanying or secondary to other tumors;
had history of venous thrombosis or received any anti-coagulation treatment;
acute infection or intravascular disseminated coagulation;
pregnancy or lactation;
history of neoadjuvant chemotherapy;
Lost to follow-up

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients first diagnosed with gastric cancer and suitable for radical resection

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dongmei Diao	First Affiliated Hospital Xi'an Jiaotong University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Xi 'an Jiaotong University		Xi'an	Shaanxi	710061	China

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

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