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NCT Number: NCT05501353

Explore Biomarkers Associated With Prognosis of Recurrent and Metastatic CRC After Surgery by Multi-omics Methods

This project is the first application, which is applied as a single center project and applied according to the screening quantity. This project is a multi-omics approach to explore biomarkers associated with prognosis after secondary radical resection of recurrent and metastatic colorectal cancer.

Main research objectives: 1. To detect DNA mutation and methylation in tumor tissues by NGS detection technology (the methylation dimension should be detected in adjacent tissues at the same time), and to explore specific molecular markers related to prognosis; 2. Using NGS test technology of blood in patients with preoperative and postoperative blood ctDNA mutations and methylation double dimension testing, respectively, to explore the preoperative and postoperative ctDNA mutations and the correlation between methylation status and recurrence, including but not limited to predict patients with recurrence of sensitivity, specificity, positive predictive value, negative predictive value and recurrence warning time and other indicators.

Main contents: This study intends to include single site for the first time/organ metastasis after radical treatment and surgical indications again in patients with colorectal adenocarcinoma (including but not limited to spread to the liver, lung metastasis, peritoneal metastasis, lymph node metastasis and other organ metastasis), collected in patients with preoperative peripheral blood and tissue samples, tissue adjacent to carcinoma and postoperative peripheral blood, NGS detection technology was used to detect DNA and mutation in the relevant samples, combined with clinical treatment and prognosis information of patients, and then explore biomarkers for predicting recurrence risk.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Lifeng Sun

CONTACT

[email protected]

139 5810 3041

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Colorectal cancer patients with first recurrence and metastasis after previous radical resection
  • Single site/organ metastasis is indicative of reoperation
  • Adenocarcinoma diagnosed by histology or cytology
  • At the time of signing the informed consent, the applicant must be 18 years old or older
  • Life expectancy is at least 12 weeks
  • ECOG score 0~1

Exclusion criteria

  • Currently participating in the intervention study treatment, or receiving other drugs or study devices within 4 weeks before enrollment
  • Concurrent with other malignant tumors
  • The investigator determined that the patient had other serious diseases that might affect follow-up and short-term survival
  • Cardiac function NYHA class III or IV heart disease
  • The presence of definite peripheral nerve disease
  • There is definite hearing loss
  • Other researchers think it is not suitable for inclusion

Treatment and study plan

No intervention

Other

This study is an observational study, which does not affect the routine diagnosis and treatment of patients and only requires the collection of biological samples at specific nodes

Primary outcomes

  1. molecular markers related to prognosis

    Time frame: up to 24 months

    The investigator collect preoperative peripheral blood, surgical tissue samples, adjacent tissues and postoperative peripheral blood from patients. DNA and mutation detection were performed on relevant samples using NGS detection technology and combined with clinical treatment and prognosis information of patients to explore the biomarkers (e.g. CtDNA mutation and ctDNA methylation were combined for MRD detection) of recurrence risk prediction.

  2. the correlation between ctDNA mutations with methylation status and recurrence

    Time frame: up to 24 months

    using NGS test technology of blood in patients with preoperative and postoperative blood ctDNA mutations and methylation double dimension testing, respectively, to explore the correlation between the preoperative and postoperative ctDNA mutations with methylation status and recurrence, including but not limited to predict relapse in patients with sensitivity, specificity, positive predictive value, negative predictive value and recurrence warning time and other indicators;

Secondary outcomes

  1. Compare the difference of DNA with ctDNA in predicting postoperative recurrence through statistical method

    Time frame: up to 24 months

    To compare the difference in the performance of DNA mutation dimension alone and ctDNA detection (DNA mutation + methylation dual dimension) in predicting postoperative recurrence through statistical method

Study contacts

Contact information is provided by the study sponsor or research team.

Lifeng Sun

CONTACT

[email protected]

13958103041

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • Guangdong Living Environment Harmless Treatment Center Co., Ltd.
  • Guangzhou Burning Rock Dx Co., Ltd.

Registry information

Official study title

Explore Biomarkers Associated With Prognosis of Recurrent and Metastatic CRC After Secondary Radical Surgery by Multi-omics Methods

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Aug 15, 2022
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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