NCT05536089Recruiting
ctDNA Methylation Application in Postoperative Relapse and Adjuvant Chemotherapy Efficacy Evaluation
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
Source: ClinicalTrials.gov · Last updated 22 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2000 (estimated)
- First submitted
- 7 Sept 2022
- Start date
- Sept 2022
- Primary completion date
- Sept 2028
- Lead sponsor
- Singlera Genomics Inc.
- Diseases
- Colorectal cancer
- NCT number
- NCT05536089
What you commit to
- Study type: Observational
- Planned participants: 2000
- From Sept 2022 to the primary completion date, Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Induction of neoadjuvant systemic therapy prior to resection of CRC.
Other illness
- Personal history of colorectal cancer, colorectal adenoma or aerodigestive tract cancer.
- 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.
Other
- Patient is pregnant or lactating.
- Inadequate tumor material (either quality and quantity) to support circulating tumor DNA (ctDNA) analysis.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Second Affiliated Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.