NCT03476057

Brief Summary

Liquid biopsy has been successfully applied to the treatment and diagnosis of cancer. cfDNA has been paid more and more attention in liquid biopsy. Previous studies have shown that cfDNA can be used for predicting the efficacy of radiotherapy or chemotherapy for lung cancer, rectal cancer and esophageal cancer. It is also reported that cfDNA can be used for the evaluation of postoperative recurrence of advanced gastric cancer. However, the use of NGS to detect cfDNA in gastrointestinal tumors has not been reported. The purpose of this study is to investigate the correlation between cfDNA, cfDNA tumor buden with advanced gastrointestinal tract tumor patients, and find out prognosis gene of advanced gastrointestinal tract tumor.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 18, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 23, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

2.5 years

First QC Date

March 18, 2018

Last Update Submit

June 28, 2018

Conditions

Gastrointestinal Cancer

Keywords

NGScfDNAOSTumor Burden

Outcome Measures

Primary Outcomes (1)

  • cfDNA

    demonstrates the spectrum of cfDNA alterations/ profiling

    6 months

Secondary Outcomes (1)

  • Tumor mutation burden

    6 months

Study Arms (1)

Advanced gastrointestinal tumor

200 patients with pathologically confirmed Advanced gastrointestinal tumor who never treated with chemotherapy at Fujian Cancer Hospital

Diagnostic Test: Device： NGS sequencing cfDNA

Interventions

Device： NGS sequencing cfDNADIAGNOSTIC_TEST

NGS sequencing cfDNA and Tumor Burden

Advanced gastrointestinal tumor

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Stage III/ IV gastrointestinal cancer

You may qualify if:

  • patients with pathologically confirmed Stage III/ IV gastrointestinal cancer
  • all patients had not received chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rongbo Lin

Fuzhou, Fujian, 350014, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, FFPE

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Central Study Contacts

Lin Rongbo, Doctor

CONTACT

+8613705919382rongbo_lin@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2018

First Posted

March 23, 2018

Study Start

July 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

July 2, 2018

Record last verified: 2018-06

Locations

CN(1)