Colon Cancer Treatment Decisions and Recurrence Predicting
CCTDRP
Circulating Tumor DNA Predict Recurrence and Aid Treatment Decisions in Colon Cancer
1 other identifier
interventional
500
1 country
1
Brief Summary
The purpose of the study is to determine the relationship between change of gene copies and recurrence，and the overall survival at 5 years after chemotherapy based on clinical prognosis compared to Oncocare detection prognosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Longer than P75 for not_applicable
1 active site
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
December 13, 2016
CompletedFirst Posted
Study publicly available on registry
December 20, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedDecember 20, 2016
December 1, 2016
11 months
December 13, 2016
December 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
patients treated with chemotherapy based on clinical prognosis compared to Oncocare detection prognosis
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 66 weeks
Secondary Outcomes (2)
the rate of gene copies change from primary detection to recurrence
From date of randomization until the date of first documented progression, assessed up to 100 weeks
Overall survival at 5 years
From date of randomization until the date of death from any cause, assessed up to 60 months
Study Arms (4)
high genetic risk and high clinical risk
OTHERon the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method
low genetic risk but high clinical risk
ACTIVE COMPARATORon the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method，randomized design，and chemotherapy for colorectal carcinoma
high genetic risk but low clinical risk
ACTIVE COMPARATORon the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method
low genetic risk and low clinical risk
OTHERon the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method
Interventions
Personalized monitoring
chemotherapy for colorectal carcinoma
Eligibility Criteria
You may qualify if:
- more than eighteen, diagnosed with colorectal cancer， not chemotherapy history, Inform consent signed.
You may not qualify if:
- Psychosocial disorder, No inform consent signed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MyGenostics Inc., Beijinglead
- Chinese PLA General Hospitalcollaborator
Study Sites (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wentong Xu, A.P.
Chinese PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2016
First Posted
December 20, 2016
Study Start
January 1, 2017
Primary Completion
December 1, 2017
Study Completion
September 1, 2022
Last Updated
December 20, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share