Neo-adjuvant Chemotherapy Evluation in Gastric Cancer Pat... | NCT05647941

Studies
Neo-adjuvant Chemotherapy Evluation in Gastric Cancer Patients Based on Circulating Exosomal LncRNA-GC1

NCT05647941

Sponsor

Chinese PLA General Hospital

Status

Unknown status

Last Update Posted

Dec 14, 2022Actual

Enrollment

700Estimated

Phase

Not provided

Conditions

Gastric Cancer
Chemotherapy Effect

Interventions

Detection of levels of circulating EV-derived lncRNA-GC1

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

Dec 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Dec 30, 2022Estimated

Completion Date

Dec 30, 2022Estimated

First Submitted Date

Dec 4, 2022

First Submission Date that Met QC Criteria

Dec 4, 2022

First Posted Date

Dec 13, 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

Dec 12, 2022

Last Update Posted Date

Dec 14, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lin Chen, Director of Department of General Surgery, Chinese PLA General Hospital, Chinese PLA General HospitalPrincipal Investigator

Lead Sponsor

Chinese PLA General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 investigators hope that through the analysis and research to find determine whether lncRNA-GC1 could serve as a non-invasive biomarker for monitoring the neo-adjuvant chemotherapy response for personalized medicine for gastric cancer.

Detailed Description

The LncRNA-GC1could noninvasively track dynamics of tumor burden and has been proposed as a real-time biomarker that can provide both predictive and prognostic values. But the value in monitoring the neo-adjuvant chemotherapy response is unclear. The investigators hope that through the analysis and research to find determine whether lncRNA-GC1 could serve as a monitoring biomarker for patients with gastric cancer receiving neo-adjuvant chemotherapy.

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

700Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Detection of levels of circulating EV-derived lncRNA-GC1	Diagnostic Test	For patients with gastric cancer receiving neo-adjuvant chemotherapy, the dynamic changes of EV-derived lncRNA-GC1 was detected to identify whether is can serve as a monitoring biomarker for treatment response.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Detection of levels of circulating exosomal lncRNA-GC1	Levels of circulating exosomal lncRNA-GC1 are detected by RT-PCR	Through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Having signed informed consent
Age≥ 18 years old
Histologically confirmed gastric adenocarcinoma
radiographically identified as advanced gastric cancer

Exclusion Criteria:

Other previous malignancy within 5 year
Surgery (excluding diagnostic biopsy) within 4 weeks prior to study
Pregnancy or lactation period
Legal incapacity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Community Sample Shanxi - Hospital and community sample Beijing -Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chinese PLA General Hospital Ethics Committee	Recruiting	Beijing	Beijing Municipality	100853	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Data may be shared until the final results published.

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