Liver MetastasesNCT06404593
Dynamic ctDNA Detection for Colorectal Cancer Liver Metastases
An observational study of Liver Metastases and Colorectal Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
Evaluating the value of dynamic monitoring of a colorectal cancer liver metastasis cohort underwent curative resection after receiving multipoint ctDNA detecting in predicting recurrence prognosis and guiding adjuvant chemotherapy treatment. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Liver Metastases, Colorectal Cancer, Surgery
- What is being tested?
- Blood sampling
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 18 Jun 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study enrolled patients with colorectal liver metastases undergoing radical resection at Hepatopancreatobiliary Surgery Department I of Peking University Cancer Hospital.
Who may be able to join
- Before implementing any trial-related procedures, written informed consent should be signed;
- >=20 and <= 85 years old, male or female;
- Patients with liver metastases pathologically confirmed as colorectal adenocarcinoma;
- According to the Response Evaluation Criteria for Solid Tumors (RECIST version 1.1), there is at least one lesion that can be measured by imaging;
- The multidisciplinary team (MDT) confirmed that the liver metastases were initially resectable ,without locally treatable extrahepatic metastases;
- The general physical condition is good (ECOG score 0-1);
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- Life expectancy of more than 3 months;
- There is no obvious symptoms of primary bleeding, obstruction and other indications for emergency surgery;
- adequate organ function;
- samples meet NGS quality control requirements;
- The subjects are able and willing to comply with the visits, treatment plans, laboratory tests and other research-related procedures stipulated in the research protocol.
Who cannot join
- Patients who are intolerant to systemic chemotherapy or surgery;
- Patients with multiple primary lesions;
- Blood samples and/or baseline tissue samples that do not meet the requirements for testing (hemolysis, low tumor cell content, insufficient DNA extraction yield, etc.);
- Excessive tissue necrosis after conversion therapy, making it impossible to sample according to testing requirements
- Patients who have not undergone surgery after conversion therapy, only receiving radiofrequency ablation or chemotherapy follow-up
- Not all metastatic lesions were resected after conversion therapy, or liver metastatic lesions did not achieve R0 resection
- No definite mutations detected in the tissue, or mutations detected in tumor tissue were not covered by the designed small panel.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dynamic ctDNA Detection for Guiding Adjuvant Therapy and Recurrence Monitoring After Curative Resection of Colorectal Cancer Liver Metastases: A Prospective Study
Evaluating the value of dynamic monitoring of a colorectal cancer liver metastasis cohort underwent curative resection after receiving multipoint ctDNA detecting in predicting recurrence prognosis and guiding adjuvant chemotherapy treatment.
- Conditions
- Liver Metastases, Colorectal Cancer, Surgery, Circulating Tumor DNA, Minimal Residual Disease
- Being tested
- Blood sampling
- Keywords
- Minimal Residual Disease, Colorectal Liver Metastases
- Medical subject headings
- Colorectal Neoplasms, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingDiagnostic test
Evaluating the value of dynamic monitoring of a colorectal cancer liver metastasis cohort after receiving multipoint ctDNA detecting in predicting recurrence prognosis and guiding adjuvant chemotherapy treatment.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Blood sampling 7 days after surgery Receives: Diagnostic Test: Blood sampling | |
| Group 2 | Blood sampling 1 month after surgery Receives: Diagnostic Test: Blood sampling | |
| Group 3 | Blood sampling 3 to 6 months after surgery Receives: Diagnostic Test: Blood sampling | |
| Group 4 | Blood sampling 6 to 9 months after surgery Receives: Diagnostic Test: Blood sampling | |
| Group 5 | Blood sampling 9 to 12 months after surgery Receives: Diagnostic Test: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Measured: 1 year
overall survival
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start18 Jun 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver MetastasesStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404593
- Sponsor's protocol ID
- PKUCRLM-1
- Status last verified
- May 2024
- First submitted
- 5 May 2024
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic ctDNA Detection for Guiding Adjuvant Therapy and Recurrence Monitoring After Curative Resection of Colorectal Cancer Liver Metastases: A Prospective Study
- ClinicalTrials.gov ID
- NCT06404593
- Acronym / sponsor ID
- PKUCRLM-1
- Conditions
- Liver Metastases, Colorectal Cancer, Surgery, Circulating Tumor DNA, Minimal Residual Disease
- Keywords
- Minimal Residual Disease, Colorectal Liver Metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 8 May 2024 (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.
Evaluating the value of dynamic monitoring of a colorectal cancer liver metastasis cohort underwent curative resection after receiving multipoint ctDNA detecting in predicting recurrence prognosis and guiding adjuvant chemotherapy treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Blood samplingBlood sampling 7 days after surgery |
| Group 2 | – | Diagnostic Test: Blood samplingBlood sampling 1 month after surgery |
| Group 3 | – | Diagnostic Test: Blood samplingBlood sampling 3 to 6 months after surgery |
| Group 4 | – | Diagnostic Test: Blood samplingBlood sampling 6 to 9 months after surgery |
| Group 5 | – | Diagnostic Test: Blood samplingBlood sampling 9 to 12 months after surgery |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study enrolled patients with colorectal liver metastases undergoing radical resection at Hepatopancreatobiliary Surgery Department I of Peking University Cancer Hospital.
Key inclusion criteria (11 listed)
- Before implementing any trial-related procedures, written informed consent should be signed;
- >=20 and <= 85 years old, male or female;
- Patients with liver metastases pathologically confirmed as colorectal adenocarcinoma;
- According to the Response Evaluation Criteria for Solid Tumors (RECIST version 1.1), there is at least one lesion that can be measured by imaging;
- The multidisciplinary team (MDT) confirmed that the liver metastases were initially resectable ,without locally treatable extrahepatic metastases;
Key exclusion criteria (7 listed)
- Patients who are intolerant to systemic chemotherapy or surgery;
- Patients with multiple primary lesions;
- Blood samples and/or baseline tissue samples that do not meet the requirements for testing (hemolysis, low tumor cell content, insufficient DNA extraction yield, etc.);
- Excessive tissue necrosis after conversion therapy, making it impossible to sample according to testing requirements
- Patients who have not undergone surgery after conversion therapy, only receiving radiofrequency ablation or chemotherapy follow-up
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 |
|---|---|---|
| Blood samplingEvaluating the value of dynamic monitoring of a colorectal cancer liver metastasis cohort after receiving multipoint ctDNA detecting in predicting recurrence prognosis and guiding adjuvant chemotherapy treatment. | Diagnostic test | Group 1, Group 2, Group 3, Group 4, Group 5 |
Primary outcome
progression-free survival
Time frame: 1 year
overall survival
Time frame: 5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Liver Metastases and Colorectal Cancer, run by Peking University Cancer Hospital & Institute 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 11 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: finished, as of the sponsor's last update on 8 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: 1 year). 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 May 2024.