NCT05501353 Explore Biomarkers Associated With Prognosis of Recurrent and Metastatic CRC After Surgery by Multi-omics Methods
| NCT ID | NCT05501353 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | Colorectal Cancer Metastatic |
| Study Type | OBSERVATIONAL |
| Enrollment | 125 participants |
| Start Date | 2022-07-22 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 125 participants in total. It began in 2022-07-22 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Colorectal cancer patients with first recurrence and metastasis after previous radical resection 2. Single site/organ metastasis is indicative of reoperation 3. Adenocarcinoma diagnosed by histology or cytology 4. At the time of signing the informed consent, the applicant must be 18 years old or older 5. Life expectancy is at least 12 weeks 6. ECOG score 0\~1 Exclusion Criteria: 1. Currently participating in the intervention study treatment, or receiving other drugs or study devices within 4 weeks before enrollment 2. Concurrent with other malignant tumors 3. The investigator determined that the patient had other serious diseases that might affect follow-up and short-term survival 4. Cardiac function NYHA class III or IV heart disease 5. The presence of definite peripheral nerve disease 6. There is definite hearing loss 7. Other researchers think it is not suitable for inclusion
Contact & Investigator
Lifeng Sun
STUDY DIRECTOR
2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
Frequently Asked Questions
Who can join the NCT05501353 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Colorectal Cancer Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05501353 currently recruiting?
Yes, NCT05501353 is actively recruiting participants. Contact the research team at sunlifeng@zju.edu.cn for enrollment information.
Where is the NCT05501353 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT05501353 clinical trial?
NCT05501353 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The principal investigator is Lifeng Sun at 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China. The trial plans to enroll 125 participants.
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