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NCT05501353Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 8 Feb 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
125 (estimated)
First submitted
31 Jul 2022
Start date
22 Jul 2022
Primary completion date
1 Sept 2027
Lead sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
NCT number
NCT05501353

What you commit to

  • Study type: Observational
  • Planned participants: 125
  • From 22 Jul 2022 to the primary completion date, 1 Sept 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Currently participating in the intervention study treatment, or receiving other drugs or study devices within 4 weeks before enrollment
  • Concurrent with other malignant tumors

Other illness

  • 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

Other

  • There is definite hearing loss
  • Other researchers think it is not suitable for inclusion

Who the study is looking for

  • 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

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Second Affiliated Hospital Zhejiang University School of Medicine
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.