Colon Cancer Treatment Decisions and Recurrence Predicting (CCTDRP)

December 15, 2016 updated by: MyGenostics Inc., Beijing

Circulating Tumor DNA Predict Recurrence and Aid Treatment Decisions in Colon Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Psychosocial disorder, No inform consent signed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: high genetic risk and high clinical risk
on the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method
Biological: OncoCare
Personalized monitoring
ACTIVE_COMPARATOR: 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
Biological: OncoCare
Personalized monitoring
Drug: chemotherapy for colorectal carcinoma
chemotherapy for colorectal carcinoma
ACTIVE_COMPARATOR: high genetic risk but low clinical risk
on the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method
Biological: OncoCare
Personalized monitoring
Drug: chemotherapy for colorectal carcinoma
chemotherapy for colorectal carcinoma
OTHER: low genetic risk and low clinical risk
on the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method
Biological: OncoCare
Personalized monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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 Measures

Outcome Measure
Time Frame
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
From date of randomization until the date of first documented progression, assessed up to 100 weeks
Overall survival at 5 years
Time Frame: From date of randomization until the date of death from any cause, assessed up to 60 months
From date of randomization until the date of death from any cause, assessed up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MyGenostics Inc., Beijing

Collaborators

Chinese PLA General Hospital

Investigators

  • Principal Investigator: Wentong Xu, A.P., Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

September 1, 2022

Study Registration Dates

First Submitted

December 13, 2016

First Submitted That Met QC Criteria

December 15, 2016

First Posted (ESTIMATE)

December 20, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 20, 2016

Last Update Submitted That Met QC Criteria

December 15, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MG-WXu

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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