Colorectal Cancer MetastaticNCT05501353
Explore Biomarkers Associated With Prognosis of Recurrent and Metastatic CRC After Surgery by Multi-omics Methods
An observational study of Colorectal Cancer Metastatic, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Colorectal Cancer Metastatic
- How many people
- 125 participants
- Where
- 1 siteChina
- Study dates
- 22 Jul 2022to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with various types of metastatic colorectal cancer who had underwent the radical resection of colorectal cancer and are planning to undergo radical resection of metastasis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Lifeng Sun, 139 5810 3041, sunlifeng@zju.edu.cn
About this study
Official title: Explore Biomarkers Associated With Prognosis of Recurrent and Metastatic CRC After Secondary Radical 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.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- no intervention
- Keywords
- Colorectal Cancer, Colorectal Cancer Metastatic, multi-omics method, biomarker
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Patients with various types of metastatic colorectal cancer who had underwent the radical resection of colorectal cancer and were planning to undergo radical resection of metastasis Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
molecular markers related to prognosis
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.
Measured: up to 24 months
the correlation between ctDNA mutations with methylation status and recurrence
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;
Measured: up to 24 months
Secondary outcomes (1)
Compare the difference of DNA with ctDNA in predicting postoperative recurrence through statistical method
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
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start22 Jul 2022
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Burning Rock Dx Co., Ltd., Guangdong Living Environment Harmless Treatment Center Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Lifeng Sun, Study director, 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501353
- Sponsor's protocol ID
- 2022-0465
- Status last verified
- Jul 2022
- First submitted
- 31 Jul 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore Biomarkers Associated With Prognosis of Recurrent and Metastatic CRC After Secondary Radical Surgery by Multi-omics Methods
- ClinicalTrials.gov ID
- NCT05501353
- Acronym / sponsor ID
- 2022-0465
- Conditions
- Colorectal Cancer Metastatic
- Keywords
- Colorectal Cancer, Colorectal Cancer Metastatic, multi-omics method, biomarker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Guangzhou Burning Rock Dx Co., Ltd., Guangdong Living Environment Harmless Treatment Center Co., Ltd.
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group1 | – | Other: no interventionPatients with various types of metastatic colorectal cancer who had underwent the radical resection of colorectal cancer and were planning to undergo radical resection of metastasis |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with various types of metastatic colorectal cancer who had underwent the radical resection of colorectal cancer and are planning to undergo radical resection of metastasis
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionThis 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 | Other | Group1 |
Primary outcome
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.
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;
1 secondary outcome
Compare the difference of DNA with ctDNA in predicting postoperative recurrence through statistical method
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lifeng Sun study director
2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Metastatic, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lifeng Sun (13958103041, sunlifeng@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
molecular markers related to prognosis (time frame: up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.