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Colon Cancer Treatment Decisions and Recurrence Predicting

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02997241
Acronym
CCTDRP
Enrollment
500
Registered
2016-12-20
Start date
2017-01-31
Completion date
2022-09-30
Last updated
2016-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Neoplasms

Keywords

Colonic Neoplasms, recurrence

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.

Interventions

BIOLOGICALOncoCare

Personalized monitoring

DRUGchemotherapy for colorectal carcinoma

chemotherapy for colorectal carcinoma

Sponsors

Chinese PLA General Hospital
CollaboratorOTHER
MyGenostics Inc., Beijing
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Psychosocial disorder, No inform consent signed.

Design outcomes

Primary

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

MeasureTime frame
the rate of gene copies change from primary detection to recurrenceFrom date of randomization until the date of first documented progression, assessed up to 100 weeks
Overall survival at 5 yearsFrom date of randomization until the date of death from any cause, assessed up to 60 months

Countries

China

Contacts

Primary ContactWentong Xu, A.P.
xuwentong@medmail.com.cn13911779137

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026