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The utility of circulating tumor DNA as a prognostic biomarker of radical surgery for metastatic colorectal cancer

The utility of circulating tumor DNA as a prognostic biomarker of radical surgery for metastatic colorectal cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800016988
Enrollment
Unknown
Registered
2018-07-06
Start date
2018-07-01
Completion date
Unknown
Last updated
2018-07-09

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

Conditions

metastatic colorectal cancer

Interventions

Case series:Nil

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Male or female aged = 18 years; 2) Colonoscopy, surgery or other pathological biopsy to diagnose as colorectal adenocarcinoma; 3) CT or MRI or B-ultrasonography or PET/CT or other imaging tests was diagnosed as local or distant organ recurrence or metastasis (liver metastasis, lung metastasis, or hepatic metastasis); 4) Molecular detection of tumor lesions identified as KRAS/NRAS/BRAF/PIK3CA mutations positive; 5) Subjects will undergo radical surgery (surgical removal of primary and metastatic lesions) after surgical evaluation; 6) Subjects have no other serious disease that conflicts with this study; 7) Subject agrees to participate in this trial and has signed an informed consent.

Exclusion criteria

Exclusion criteria: 1) Colonoscopy or surgery or other pathological biopsy diagnose as colorectal neuroendocrine tumors; 2) Diagnosis as nonmetastatic colorectal cancer; 3) Fail to acquire tumor lesion KRAS,NRAS,BRAF,PI3KCA mutation status or mutation status is negative; 4) Other complications that lead to radical resection unavailable; 5) Subjects who participated in other clinical trials within 4 weeks before enrollment; 6) Subjects with tumor recurrence within 3 months after surgery; 7) Subjects who has serious complications after surgery that cannot be followed by subsequent treatment; 8) Subjects who had blood transfusion or other blood products within one month; 9) Subjects who has adverse reactions above CTC-AE2 in preoperative conversion therapy or neoadjuvant treatment that did not return to grade 1; 10) Subjects who cannot participate in this study for other reasons; 11) Subjects who's compliance is insufficient or may not follow the follow-up procedure; 12) Subjects have diseases that interfere with the study: such as mental illness or drug abuse.

Design outcomes

Primary

MeasureTime frame
Allelic frequency of ctDNA;

Secondary

MeasureTime frame
levels of serum biomarkers;

Countries

China

Contacts

Public ContactWei Guo

Zhongshan Hospital, Fudan University

guo.wei@zs-hospital.sh.cn+86 021-64041990

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026