Colorectal CancerNCT03737539
Dynamic Monitoring of ctDNA Methylation to Predict Relapse in Colorectal Cancer After Radical Resection (POSTCA)
An observational study of Colorectal Cancer and Circulating Tumor DNA, run by Fudan University at 1 site in China.
Trial summary
This is a prospective, multicenter, observational, single-blinded controlled study. Dynamic monitoring of patients with resectable colorectal cancer was performed using the previously established colorectal tumor-specific plasma ctDNA methylation markers (Multigene methylation detection). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Circulating Tumor DNA, Surveillance
- What is being tested?
- Multigene methylation detection
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 1 Jun 2024
- How long will I take part?
- 2 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with resectable colorectal cancer must have baseline evaluations performed prior to the study and must meet all inclusion and exclusion criteria. In addition, the patient must be thoroughly informed about all aspects of the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent.
Who may be able to join
- Male or female ≥ 18 years of age on the day of signing informed consent.
- Patients must have histologically confirmed colorectal cancer.
- Patients need to receive surgical resection.
- Patients must have a performance status of ≤1 on the ECOG Performance Scale.
- Life expectancy of more than 5 years.
- Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study.
Who cannot join
- Patients received adjuvant treatment prior to the surgical resection.
- Patients received blood transfusion two weeks before or during the surgical resection.
- Patients with unresected advanced colorectal adenoma.
- Patients who are positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C.
- Patients who are pregnant.
- Patients who are alcoholic or drug abusers.
- Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Guoxiang Cai, M.D. Ph.D.
About this study
Official title: Dynamic Monitoring of Circulating Tumor DNA Methylation to Predict Relapse in Colorectal Cancer After Radical Resection: A Prospective, Multicenter, Clinical Study (POSTCA)
This is a prospective, multicenter, observational, single-blinded controlled study. Dynamic monitoring of patients with resectable colorectal cancer was performed using the previously established colorectal tumor-specific plasma ctDNA methylation markers (Multigene methylation detection). Dynamic monitoring of plasma ctDNA methylation before and after treatment and at regular follow-up in patients with colorectal cancer after radical resection of tumor, to explore the predictive effect of postoperative plasma ctDNA methylation on postoperative recurrence and whether dynamic monitoring of postoperative ctDNA methylation could be earlier than imaging examination to indicate tumor recurrence.
Read the detailed description
At present, the main treatment of colorectal cancer (CRC) is surgical resection. CRC patients after radical surgery have good overall survival. However, there are still a large number of patients with postoperative recurrence. The postoperative recurrence rate of stage II CRC patients is 20-30%, and that of stage III CRC patients is 50-60%. Currently, there is no effective measures to predict whether patients suffer postoperative relapse. Patients can only periodically visit doctors in the hope of timely treatment in case of recurrence. Current clinical monitoring methods mainly include imaging detection and tumor markers detection. However, long-term monitoring may affect patients' quality of life and increase patients' economic burden. Therefore, biomarkers that can predict the prognosis of patients and screen out those who need intensive follow up are urgently warranted. At present, imaging is the mainly used approach to monitor tumor recurrence. Quantitative determination of ctDNA methylation in plasma may find tumor recurrence trend before imaging detection, indicating that quantitative determination of ctDNA methylation in plasma is a more sensitive monitoring approach than traditional imaging detection. Can plasma ctDNA methylation be a new recurrence monitoring technique and prognostic prediction method of CRC in clinical practice? In this study, we aimed to monitor the dynamic level of plasma ctDNA methylation after surgery in CRC patients, and to explore the advantages of plasma ctDNA methylation detection over traditional CRC in recurrence monitoring and prognosis prediction. This is a prospective, multicenter, observational, single-blinded controlled study. Dynamic monitoring of CRC patients was performed using the previously established colorectal tumor-specific plasma ctDNA methylation markers. Dynamic monitoring of plasma ctDNA methylation before and after treatment and at regular follow-up in patients with CRC after radical resection of tumor, to explore the predictive effect of postoperative plasma ctDNA methylation on postoperative recurrence and whether dynamic monitoring of postoperative ctDNA methylation could be earlier than imaging examination to indicate tumor recurrence.
- Conditions
- Colorectal Cancer, Circulating Tumor DNA, Surveillance, Methylation
- Being tested
- Multigene methylation detection
- Keywords
- Colorectal Cancer, Circulating tumor DNA, Surveillance, ctDNA Methylation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multigene methylation detectionDiagnostic test
Colorectal tumor-specific plasma ctDNA methylation markers detection
| Study group | Role | What they receive |
|---|---|---|
| Colorectal cancer | Patients diagnosed with resectable colorectal cancer Receives: Diagnostic Test: Multigene methylation detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival (DFS)
The primary endpoint for this study is Disease Free Survival (DFS), which will be assessed using RECIST version 1.1.
Measured: 2-year DFS
ctDNA methylation markers versus CT/MRI
ctDNA methylation predictors of outcome will be compared to CT/MRI
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start1 Sep 2018
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 300 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Second Military Medical University, Shanghai University of Traditional Chinese Medicine, RenJi Hospital, Hebei Medical University Fourth Hospital
- Responsible party
- Principal investigator, Guoxiang Cai, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737539
- Sponsor's protocol ID
- FDCRC42-CGX (POSTCA trial)
- Status last verified
- May 2023
- First submitted
- 8 Nov 2018
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Monitoring of Circulating Tumor DNA Methylation to Predict Relapse in Colorectal Cancer After Radical Resection: A Prospective, Multicenter, Clinical Study (POSTCA)
- ClinicalTrials.gov ID
- NCT03737539
- Acronym / sponsor ID
- FDCRC42-CGX (POSTCA trial)
- Conditions
- Colorectal Cancer, Circulating Tumor DNA, Surveillance, Methylation
- Keywords
- Colorectal Cancer, Circulating tumor DNA, Surveillance, ctDNA Methylation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Second Military Medical University, Shanghai University of Traditional Chinese Medicine, RenJi Hospital, Hebei Medical University Fourth Hospital
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 9 Nov 2018 (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 is a prospective, multicenter, observational, single-blinded controlled study. Dynamic monitoring of patients with resectable colorectal cancer was performed using the previously established colorectal tumor-specific plasma ctDNA methylation markers (Multigene methylation detection). Dynamic monitoring of plasma ctDNA methylation before and after treatment and at regular follow-up in patients with colorectal cancer after radical resection of tumor, to explore the predictive effect of postoperative plasma ctDNA methylation on postoperative recurrence and whether dynamic monitoring of postoperative ctDNA methylation could be earlier than imaging examination to indicate tumor recurrence.
Detailed description
At present, the main treatment of colorectal cancer (CRC) is surgical resection. CRC patients after radical surgery have good overall survival. However, there are still a large number of patients with postoperative recurrence. The postoperative recurrence rate of stage II CRC patients is 20-30%, and that of stage III CRC patients is 50-60%. Currently, there is no effective measures to predict whether patients suffer postoperative relapse. Patients can only periodically visit doctors in the hope of timely treatment in case of recurrence. Current clinical monitoring methods mainly include imaging detection and tumor markers detection. However, long-term monitoring may affect patients' quality of life and increase patients' economic burden. Therefore, biomarkers that can predict the prognosis of patients and screen out those who need intensive follow up are urgently warranted. At present, imaging is the mainly used approach to monitor tumor recurrence. Quantitative determination of ctDNA methylation in plasma may find tumor recurrence trend before imaging detection, indicating that quantitative determination of ctDNA methylation in plasma is a more sensitive monitoring approach than traditional imaging detection. Can plasma ctDNA methylation be a new recurrence monitoring technique and prognostic prediction method of CRC in clinical practice? In this study, we aimed to monitor the dynamic level of plasma ctDNA methylation after surgery in CRC patients, and to explore the advantages of plasma ctDNA methylation detection over traditional CRC in recurrence monitoring and prognosis prediction. This is a prospective, multicenter, observational, single-blinded controlled study. Dynamic monitoring of CRC patients was performed using the previously established colorectal tumor-specific plasma ctDNA methylation markers. Dynamic monitoring of plasma ctDNA methylation before and after treatment and at regular follow-up in patients with CRC after radical resection of tumor, to explore the predictive effect of postoperative plasma ctDNA methylation on postoperative recurrence and whether dynamic monitoring of postoperative ctDNA methylation could be earlier than imaging examination to indicate tumor recurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal cancer | – | Diagnostic Test: Multigene methylation detectionPatients diagnosed with resectable colorectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with resectable colorectal cancer must have baseline evaluations performed prior to the study and must meet all inclusion and exclusion criteria. In addition, the patient must be thoroughly informed about all aspects of the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent.
Key inclusion criteria (6 listed)
- Male or female ≥ 18 years of age on the day of signing informed consent.
- Patients must have histologically confirmed colorectal cancer.
- Patients need to receive surgical resection.
- Patients must have a performance status of ≤1 on the ECOG Performance Scale.
- Life expectancy of more than 5 years.
Key exclusion criteria (7 listed)
- Patients received adjuvant treatment prior to the surgical resection.
- Patients received blood transfusion two weeks before or during the surgical resection.
- Patients with unresected advanced colorectal adenoma.
- Patients who are positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C.
- Patients who are pregnant.
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 |
|---|---|---|
| Multigene methylation detectionColorectal tumor-specific plasma ctDNA methylation markers detection | Diagnostic test | Colorectal cancer |
Primary outcome
Disease Free Survival (DFS)
Time frame: 2-year DFS
The primary endpoint for this study is Disease Free Survival (DFS), which will be assessed using RECIST version 1.1.
ctDNA methylation markers versus CT/MRI
Time frame: 2 years
ctDNA methylation predictors of outcome will be compared to CT/MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
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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.
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 and Circulating Tumor DNA, run by Fudan University 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: status not confirmed, as of the sponsor's last update on 19 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guoxiang Cai, M.D. Ph.D. (+86 13611831623, gxcai@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free Survival (DFS) (time frame: 2-year DFS). 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 19 May 2023.