NCT05767697

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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

April 15, 2020

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 14, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

4.7 years

First QC Date

March 2, 2023

Last Update Submit

March 25, 2024

Conditions

GI CancerLiver Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of subjects who still survive at 1 year

    1 year overall survival rate

    1 year

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • Cannot cooperate with blood sampling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Cheng-Kung University Hospital

Tainan, Taiwan

RECRUITING

National Institute of Cancer Research

Tainan, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Clinical biospecimen including blood, plasma, bile, stool, urine, fluid aspirate and tumor/normal tissue will be collected.

MeSH Terms

Conditions

Gastrointestinal NeoplasmsLiver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesLiver Diseases

Study Officials

  • Li-Tzong Chen, MD PhD

    National Health Research Institutes, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yung-Yeh Su, MD

CONTACT

+886-6-7000123yysu@nhri.edu.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2023

First Posted

March 14, 2023

Study Start

April 15, 2020

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

March 26, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(2)