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Trial record 11 of 598 for:    "Colonic Neoplasms"

Colon Cancer Treatment Decisions and Recurrence Predicting (CCTDRP)

This study is not yet open for participant recruitment.
Verified December 2016 by MyGenostics Inc., Beijing
Sponsor:
ClinicalTrials.gov Identifier:
NCT02997241
First Posted: December 20, 2016
Last Update Posted: December 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Chinese PLA General Hospital
Information provided by (Responsible Party):
MyGenostics Inc., Beijing
  Purpose
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.

Condition Intervention
Colonic Neoplasms Biological: OncoCare Drug: chemotherapy for colorectal carcinoma

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Circulating Tumor DNA Predict Recurrence and Aid Treatment Decisions in Colon Cancer

Further study details as provided by MyGenostics Inc., Beijing:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]
  • Overall survival at 5 years [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 60 months ]

Estimated Enrollment: 500
Study Start Date: January 2017
Estimated Study Completion Date: September 2022
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Psychosocial disorder, No inform consent signed.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02997241


Contacts
Contact: Wentong Xu, A.P. 13911779137 xuwentong@medmail.com.cn

Locations
China, Beijing
Chinese PLA General Hospital Not yet recruiting
Beijing, Beijing, China, 100853
Contact: Wentong Xu, A.P.    13911779137    xuwentong@medmail.com.cn   
Sponsors and Collaborators
MyGenostics Inc., Beijing
Chinese PLA General Hospital
Investigators
Principal Investigator: Wentong Xu, A.P. Chinese PLA General Hospital
  More Information

Responsible Party: MyGenostics Inc., Beijing
ClinicalTrials.gov Identifier: NCT02997241     History of Changes
Other Study ID Numbers: MG-WXu
First Submitted: December 13, 2016
First Posted: December 20, 2016
Last Update Posted: December 20, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by MyGenostics Inc., Beijing:
Colonic Neoplasms
recurrence

Additional relevant MeSH terms:
Colonic Neoplasms
Recurrence
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes