Cancer ColorectalNCT05536089
ctDNA Methylation Application in Postoperative Relapse and Adjuvant Chemotherapy Efficacy Evaluation
An observational study of Cancer Colorectal, run by Singlera Genomics Inc. at 1 site in China.
Trial summary
In this study, the investigators aimed to apply their previously developed multi-locus blood-based assay targeting circulating tumor DNA methylation to monitor postoperative relapse and evaluate adjuvant chemotherapy efficacy in resected stage I and stage II (without high risk) colorectal cancer after radical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Colorectal
- What is being tested?
- a multi-locus blood-based assay
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2022to Dec 2028
- How long will I take part?
- 5 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 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. The written informed consent must be obtained from the patient prior to enrollment. The following criteria apply to all patients enrolled onto the study unless otherwise specified.
Who may be able to join
- Patients must have histologically confirmed stage I/II (without high risk) colorectal cancer.
- Male or female ≥ 18 years of age on the day of signing informed consent.
- Patients need to receive surgical resection, and with ctDNA positive prior to resection of colorectal cancer (CRC).
- Patients must have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- 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
- Personal history of colorectal cancer, colorectal adenoma or aerodigestive tract cancer.
- Induction of neoadjuvant systemic therapy prior to resection of CRC.
- Patient is pregnant or lactating.
- 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.
- Inadequate tumor material (either quality and quantity) to support circulating tumor DNA (ctDNA) analysis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rui Liu, Ph.D contact
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital
Hangzhou, Zhejiang, 310009
HongFeng Cao, Ph.D, 13957117804, hongfengcao@zju.edu.cn
About this study
Official title: ctDNA Methylation Used to Monitor Postoperative Relapse and Evaluate Adjuvant Chemotherapy Efficacy in Resected Stage I and Stage II (Without High Risk) Colorectal Cancer After Radical Resection
In this study, the investigators aimed to apply their previously developed multi-locus blood-based assay targeting circulating tumor DNA methylation to monitor postoperative relapse and evaluate adjuvant chemotherapy efficacy in resected stage I and stage II (without high risk) colorectal cancer after radical resection.
Read the detailed description
This is a prospective, multicenter, observational, real-world study. Research objects: patients with surgically resectable colorectal cancer and ctDNA positive before surgery in stage I and stage II (without high risk). After giving fully informed consent, the participants will undergo the regular treatment according to NCCN guidelines. Serial analysis of ctDNA will be performed at specific time points including pre-treatment, postoperative week 3, postoperative 5 years ( every 3 months for the first 2 years, and every 6 months for the rest 3 years). Participants will be observed and examined during the follow-up period.
- Conditions
- Cancer Colorectal
- Being tested
- a multi-locus blood-based assay
- Keywords
- early detection
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a multi-locus blood-based assayDiagnostic test
Colorectal tumor-specific plasma ctDNA methylation markers detection
| Study group | Role | What they receive |
|---|---|---|
| ctDNA positive | Postoperative ctDNA positive Receives: Diagnostic Test: a multi-locus blood-based assay | |
| ctDNA negative | Postoperative ctDNA negative Receives: Diagnostic Test: a multi-locus blood-based assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
5y DFS
The 5-year disease free survival rate of the patients from both cohorts.
Measured: 5 years
ctDNA methylation markers versus CT/MRI
ctDNA methylation predictors of outcome will be compared to CT/MRI
Measured: 5 years
Secondary outcomes (1)
3y DFS
The 3-year disease free survival rate of the patients from both cohorts.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start5 Sep 2022
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer ColorectalStudies of the same condition, open and under way.
- 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
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Singlera Genomics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- KeFeng Ding, Ph.D, Study director, Second Affiliated Hospital, Zhejiang University, School of MedicineRui Liu, Ph.D, Principal investigator, Singlera Genomics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536089
- Sponsor's protocol ID
- Recovery-C
- Status last verified
- May 2024
- First submitted
- 7 Sep 2022
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cai G, Cai M, Feng Z, Liu R, Liang L, Zhou P; ColonAiQ Group; Zhu B, Mo S, Wang H, Lan X, Cai S, Xu Y, Wang R, Dai W, Han L, Xiang W, Wang B, Guo W, Zhang L, Zhou C, Luo B, Li Y, Nie Y, Ma C, Su Z. A Multilocus Blood-Based Assay Targeting Circulating Tumor DNA Methylation Enables Early Detection and Early Relapse Prediction of Colorectal Cancer. Gastroenterology. 2021 Dec;161(6):2053-2056.e2. doi: 10.1053/j.gastro.2021.08.054. Epub 2021 Sep 4. No abstract available.
PubMed 34487783
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ctDNA Methylation Used to Monitor Postoperative Relapse and Evaluate Adjuvant Chemotherapy Efficacy in Resected Stage I and Stage II (Without High Risk) Colorectal Cancer After Radical Resection
- ClinicalTrials.gov ID
- NCT05536089
- Acronym / sponsor ID
- Recovery-C
- Conditions
- Cancer Colorectal
- Keywords
- early detection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Singlera Genomics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 Sep 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.
In this study, the investigators aimed to apply their previously developed multi-locus blood-based assay targeting circulating tumor DNA methylation to monitor postoperative relapse and evaluate adjuvant chemotherapy efficacy in resected stage I and stage II (without high risk) colorectal cancer after radical resection.
Detailed description
This is a prospective, multicenter, observational, real-world study. Research objects: patients with surgically resectable colorectal cancer and ctDNA positive before surgery in stage I and stage II (without high risk). After giving fully informed consent, the participants will undergo the regular treatment according to NCCN guidelines. Serial analysis of ctDNA will be performed at specific time points including pre-treatment, postoperative week 3, postoperative 5 years ( every 3 months for the first 2 years, and every 6 months for the rest 3 years). Participants will be observed and examined during the follow-up period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ctDNA positive | – | Diagnostic Test: a multi-locus blood-based assayPostoperative ctDNA positive |
| ctDNA negative | – | Diagnostic Test: a multi-locus blood-based assayPostoperative ctDNA negative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 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. The written informed consent must be obtained from the patient prior to enrollment. The following criteria apply to all patients enrolled onto the study unless otherwise specified.
Key inclusion criteria (5 listed)
- Patients must have histologically confirmed stage I/II (without high risk) colorectal cancer.
- Male or female ≥ 18 years of age on the day of signing informed consent.
- Patients need to receive surgical resection, and with ctDNA positive prior to resection of colorectal cancer (CRC).
- Patients must have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- 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.
Key exclusion criteria (5 listed)
- Personal history of colorectal cancer, colorectal adenoma or aerodigestive tract cancer.
- Induction of neoadjuvant systemic therapy prior to resection of CRC.
- Patient is pregnant or lactating.
- 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.
- Inadequate tumor material (either quality and quantity) to support circulating tumor DNA (ctDNA) analysis.
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 |
|---|---|---|
| a multi-locus blood-based assayColorectal tumor-specific plasma ctDNA methylation markers detection | Diagnostic test | ctDNA negative, ctDNA positive |
Primary outcome
5y DFS
Time frame: 5 years
The 5-year disease free survival rate of the patients from both cohorts.
ctDNA methylation markers versus CT/MRI
Time frame: 5 years
ctDNA methylation predictors of outcome will be compared to CT/MRI
1 secondary outcome
3y DFS
Time frame: 3 years
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 22 May 2024.
- Results publication: PubMed 34487783Cai G, Cai M, Feng Z, Liu R, Liang L, Zhou P; ColonAiQ Group; Zhu B, Mo S, Wang H, Lan X, Cai S, Xu Y, Wang R, Dai W, Han L, Xiang W, Wang B, Guo W, Zhang L, Zhou C, Luo B, Li Y, Nie Y, Ma C, Su Z. A Multilocus Blood-Based Assay Targeting Circulating Tumor DNA Methylation Enables Early Detection and Early Relapse Prediction of Colorectal Cancer. Gastroenterology. 2021 Dec;161(6):2053-2056.e2. doi: 10.1053/j.gastro.2021.08.054. Epub 2021 Sep 4. No abstract available.
- Individual participant dataSharing planned: No
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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.
Rui Liu, Ph.D contact
KeFeng Ding, Ph.D study director
Second Affiliated Hospital, Zhejiang University, School of Medicine
Rui Liu, Ph.D principal investigator
Singlera Genomics Inc.
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 Cancer Colorectal, run by Singlera Genomics Inc. 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 5 inclusion and 5 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 22 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?
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 HongFeng cao, Ph.D (13957117804, hongfengcao@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5y DFS (time frame: 5 years). 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?
On the ClinicalTrials.gov record for NCT05536089, which also lists 1 linked publication.
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 22 May 2024.