Colon Cancer Treatment Decisions and Recurrence Predicting
NCT ID: NCT02997241
Last Updated: 2016-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
500 participants
INTERVENTIONAL
2017-01-31
2022-09-30
Brief Summary
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Detailed Description
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Cell-free DNA(cfDNA)，the free form of DNA in the plasma，derived from the normal cells, the abnormal cells (such as tumor cells) or external (such as viral DNA). The plasma cell-free DNA derived from tumor cells is the circulating tumour DNA(ctDNA).
As most solid tumors, including CRC, release ctDNA into the blood,precision medical applications of ctDNA liquid biopsy in colorectal cancer to predict recurrence and aid treatment decisions has become a hot topic.
Recent research shows that substantially all of colorectal cancer patients have somatic genetic alterations, including both single-base mutation and larger somatic structural variations (SSVs). Mutations in these genes can be used as biomarkers to evaluate tumor burden, predict recurrence and supply information for treatment decisions through monitor and quantify ctDNA.
In this program，sequencing the tissue from colorectal cancer patients by capture technology TM and next generation sequencing(NGS),the specific somatic mutations，the so-called biomarkers, can be found.The analysis results of sequencing can help to the study of tumor molecular pathology and supply information for targetable drug.The continuous monitoring of biomarkers in the plasma can predict recurrence and supply information for treatment decisions.
In phase I trials， recruit 200 volunteers with colorectal cancer will be recruited.the investigators will test the recurrence predicting project through OncocareTM(method mentioned above). In phase Ⅱ trials，the colorectal cancer patients will be categorized into four groups on the basis of genetic risk judged by OncocareTM and clinical risk judged by Clinical routine method. Particular emphasis is on the group of low genetic risk but high clinical risk and the group of high genetic risk but low clinical risk.
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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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high genetic risk and high clinical risk
on the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method
OncoCare
Personalized monitoring
low genetic risk but high clinical risk
on the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method，randomized design，and chemotherapy for colorectal carcinoma
OncoCare
Personalized monitoring
chemotherapy for colorectal carcinoma
chemotherapy for colorectal carcinoma
high genetic risk but low clinical risk
on the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method
OncoCare
Personalized monitoring
chemotherapy for colorectal carcinoma
chemotherapy for colorectal carcinoma
low genetic risk and low clinical risk
on the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method
OncoCare
Personalized monitoring
Interventions
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OncoCare
Personalized monitoring
chemotherapy for colorectal carcinoma
chemotherapy for colorectal carcinoma
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
MyGenostics Inc., Beijing
INDUSTRY
Responsible Party
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Principal Investigators
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Wentong Xu, A.P.
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Locations
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Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Wentong Xu, A.P.
Role: primary
Other Identifiers
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MG-WXu
Identifier Type: -
Identifier Source: org_study_id