Genomics and Prognosis in GI Cancers | NCT05767697

Studies
Genomics and Prognosis in GI Cancers

NCT05767697

Sponsor

National Health Research Institutes, Taiwan

Status

Unknown status

Last Update Posted

Mar 26, 2024Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

GI Cancer
Liver Cancer

Interventions

Not provided

Countries

Taiwan

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

Mar 2024

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

Apr 15, 2020Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Mar 2, 2023

First Submission Date that Met QC Criteria

Mar 2, 2023

First Posted Date

Mar 14, 2023Actual

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

Mar 25, 2024

Last Update Posted Date

Mar 26, 2024Actual

Name	Class
National Cheng-Kung University Hospital	OTHER

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

This study aims to collect biospecimens and explore the correlation of genomics and prognosis in alimentary tract cancers.

Detailed Description

In this study, the investigators will collect clinical specimens of alimentary tract cancers and perform DNA and RNA analysis to identify genetic alterations for the development of a comprehensive somatic mutation databases and investigate their potential correlation with clinical, radiological and pathological variables. The genomics study included but not limited to target gene panel sequencing, whole exome sequencing, whole genome sequencing, bulk RNA sequencing, single cell RNA sequencing and metagenomics.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of subjects who still survive at 1 year	1 year overall survival rate	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Able to sign the informed consent
Age >= 20
Histology proved pancreatic cancer, esophageal cancer, gastric cancer, hepatocellular carcinoma, cholangiocarcinoma, colorectal cancer
Agree to provide tumor/normal tissue including but not limited to surgical specimen, biopsy, cytology specimen, bile, urine or stool
Agree to receive blood sampling 20ml at first time and 10ml during each follow-up (total sampling amount no more than 30ml per month)

Exclusion Criteria:

Cannot cooperate with blood sampling

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Histology proved pancreatic cancer, esophageal cancer, gastric cancer, hepatocellular carcinoma, cholangiocarcinoma, colorectal cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yung-Yeh Su, MD	Contact	+886-6-7000123	65181	yysu@nhri.edu.tw

Overall Officials

Name	Affiliation	Role
Li-Tzong Chen, MD PhD	National Health Research Institutes, Taiwan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cheng-Kung University Hospital	Recruiting	Tainan			Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D008113	Liver Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided