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Colon Cancer Treatment Decisions and Recurrence Predicting (CCTDRP)

Primary Purpose

Colonic Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
OncoCare
chemotherapy for colorectal carcinoma
Sponsored by
MyGenostics Inc., Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colonic Neoplasms focused on measuring Colonic Neoplasms, recurrence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • more than eighteen, diagnosed with colorectal cancer, not chemotherapy history, Inform consent signed.

Exclusion Criteria:

  • Psychosocial disorder, No inform consent signed.

Sites / Locations

  • Chinese PLA General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Active Comparator

Active Comparator

Other

Arm Label

high genetic risk and high clinical risk

low genetic risk but high clinical risk

high genetic risk but low clinical risk

low genetic risk and low clinical risk

Arm Description

on the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method

on the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method,randomized design,and chemotherapy for colorectal carcinoma

on the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method

on the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method

Outcomes

Primary Outcome Measures

patients treated with chemotherapy based on clinical prognosis compared to Oncocare detection prognosis

Secondary Outcome Measures

the rate of gene copies change from primary detection to recurrence
Overall survival at 5 years

Full Information

First Posted
December 13, 2016
Last Updated
December 15, 2016
Sponsor
MyGenostics Inc., Beijing
Collaborators
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02997241
Brief Title
Colon Cancer Treatment Decisions and Recurrence Predicting
Acronym
CCTDRP
Official Title
Circulating Tumor DNA Predict Recurrence and Aid Treatment Decisions in Colon Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MyGenostics Inc., Beijing
Collaborators
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Colorectal cancer is the third most common cancer worldwide. About two-thirds of the patients have a good therapeutic effect by combining surgical adjuvant treatment. But there are still 30-40% of patients may relapse. Efficient relapse early surveillance and accurate treatment decisions can avoid excessive medical treatment,and keep timely intervention to tumor recurrence as well. That's very important to extend the survival of patients. Currently, the efficient surveillance tools recommended by surveillance guidelines include clinical assessment, serum carcinoembryonic antigen testing, colonoscopy and CT. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms
Keywords
Colonic Neoplasms, recurrence

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
high genetic risk and high clinical risk
Arm Type
Other
Arm Description
on the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method
Arm Title
low genetic risk but high clinical risk
Arm Type
Active Comparator
Arm Description
on the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method,randomized design,and chemotherapy for colorectal carcinoma
Arm Title
high genetic risk but low clinical risk
Arm Type
Active Comparator
Arm Description
on the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method
Arm Title
low genetic risk and low clinical risk
Arm Type
Other
Arm Description
on the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method
Intervention Type
Biological
Intervention Name(s)
OncoCare
Intervention Description
Personalized monitoring
Intervention Type
Drug
Intervention Name(s)
chemotherapy for colorectal carcinoma
Intervention Description
chemotherapy for colorectal carcinoma
Primary Outcome Measure Information:
Title
patients treated with chemotherapy based on clinical prognosis compared to Oncocare detection prognosis
Time Frame
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 Outcome Measure Information:
Title
the rate of gene copies change from primary detection to recurrence
Time Frame
From date of randomization until the date of first documented progression, assessed up to 100 weeks
Title
Overall survival at 5 years
Time Frame
From date of randomization until the date of death from any cause, assessed up to 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: more than eighteen, diagnosed with colorectal cancer, not chemotherapy history, Inform consent signed. Exclusion Criteria: Psychosocial disorder, No inform consent signed.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wentong Xu, A.P.
Phone
13911779137
Email
xuwentong@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wentong Xu, A.P.
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wentong Xu, A.P.
Phone
13911779137
Email
xuwentong@medmail.com.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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Colon Cancer Treatment Decisions and Recurrence Predicting

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