Colonic NeoplasmsCCTDRPNCT02997241
Colon Cancer Treatment Decisions and Recurrence Predicting
A study testing OncoCare and chemotherapy for colorectal carcinoma in people with Colonic Neoplasms, run by MyGenostics Inc., Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Neoplasms
- What is being tested?
- OncoCare and chemotherapy for colorectal carcinoma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- more than eighteen, diagnosed with colorectal cancer， not chemotherapy history, Inform consent signed.
Who cannot join
- Psychosocial disorder, No inform consent signed.
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Wentong Xu, A.P., 13911779137, xuwentong@medmail.com.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Colonic Neoplasms
- Being tested
- OncoCare, chemotherapy for colorectal carcinoma
- Keywords
- Colonic Neoplasms, recurrence
- Medical subject headings
- Colonic Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OncoCareBiological
Personalized monitoring
chemotherapy for colorectal carcinomaDrug
chemotherapy for colorectal carcinoma
| Study group | Role | What they receive |
|---|---|---|
| high genetic risk and high clinical risk | Other | on the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method Receives: Biological: OncoCare |
| low genetic risk but high clinical risk | Active comparator | on the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method，randomized design，and chemotherapy for colorectal carcinoma Receives: Biological: OncoCare; Drug: chemotherapy for colorectal carcinoma |
| high genetic risk but low clinical risk | Active comparator | on the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method Receives: Biological: OncoCare; Drug: chemotherapy for colorectal carcinoma |
| low genetic risk and low clinical risk | Other | on the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method Receives: Biological: OncoCare |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients treated with chemotherapy based on clinical prognosis compared to Oncocare detection prognosis
Measured: 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
Measured: From date of randomization until the date of first documented progression, assessed up to 100 weeks
Overall survival at 5 years
Measured: From date of randomization until the date of death from any cause, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2017 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MyGenostics Inc., Beijing
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chinese PLA General Hospital
- Responsible party
- Sponsor
- Investigators
- Wentong Xu, A.P., Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997241
- Sponsor's protocol ID
- MG-WXu
- Acronym
- CCTDRP
- Status last verified
- Dec 2016
- First submitted
- 13 Dec 2016
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA Predict Recurrence and Aid Treatment Decisions in Colon Cancer
- ClinicalTrials.gov ID
- NCT02997241
- Acronym / sponsor ID
- CCTDRP / MG-WXu
- Conditions
- Colonic Neoplasms
- Keywords
- Colonic Neoplasms, recurrence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- MyGenostics Inc., BeijingIndustry (pharma, biotech, devices)
- Collaborators
- Chinese PLA General Hospital
- Study start
- Jan 2017
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 20 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| high genetic risk and high clinical risk | Other | Biological: OncoCareon the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method |
| low genetic risk but high clinical risk | Active comparator | Biological: OncoCare, Drug: chemotherapy for colorectal carcinomaon 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 comparator | Biological: OncoCare, Drug: chemotherapy for colorectal carcinomaon the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method |
| low genetic risk and low clinical risk | Other | Biological: OncoCareon the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- more than eighteen, diagnosed with colorectal cancer， not chemotherapy history, Inform consent signed.
Key exclusion criteria (1 listed)
- Psychosocial disorder, No inform consent signed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OncoCarePersonalized monitoring | Biological | high genetic risk and high clinical risk, high genetic risk but low clinical risk, low genetic risk and low clinical risk, low genetic risk but high clinical risk |
| chemotherapy for colorectal carcinomachemotherapy for colorectal carcinoma | Drug | high genetic risk but low clinical risk, low genetic risk but high clinical risk |
Primary outcome
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
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wentong Xu, A.P. principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OncoCare and chemotherapy for colorectal carcinoma in people with Colonic Neoplasms, run by MyGenostics Inc., Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wentong Xu, A.P. (13911779137, xuwentong@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2016.