CENSURE for Colorectal Cancer
(CENSURE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to develop a test to predict the recurrence of colorectal cancer (CRC) in patients who have already received treatment. It focuses on individuals with stage II or III colorectal cancer who underwent surgery and chemotherapy. Researchers will examine DNA to identify patterns associated with cancer recurrence. The study seeks participants with stage II (high-risk) or III colorectal cancer who have had surgery and chemotherapy and are currently cancer-free. As an unphased trial, it offers patients the chance to contribute to groundbreaking research that could enhance future cancer care.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this assay is safe for predicting disease recurrence in colorectal cancer patients?
Research has shown that treating colorectal cancer, especially in early stages like II and III, often involves surgery followed by chemotherapy. This combination helps eliminate any remaining cancer cells. Studies have found that patients receiving these treatments have a high chance of survival, with over 80% living for at least five years after treatment.
Chemotherapy given after surgery is generally well-tolerated in terms of safety. While some side effects can occur, they are usually manageable. Common issues might include fatigue or nausea, but not everyone experiences these.
Regarding new tests like CENSURE, which predict if cancer might return, these tests do not involve taking new medications. They are designed to help doctors better understand the risk of cancer recurrence. Therefore, the safety concerns usually linked to new drugs do not apply here, making participation in such a study generally low-risk in terms of treatment safety.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to understand why some Stage II/III colorectal cancer patients experience cancer recurrence while others do not, despite receiving the same standard treatments, like surgery and adjuvant chemotherapy. This study could uncover crucial factors or markers that predict recurrence, potentially leading to more personalized treatment plans in the future. By distinguishing between patients with and without recurrence, the trial could pave the way for new preventive strategies and improve long-term outcomes for colorectal cancer patients.
What evidence suggests that the CENSURE assay is effective for predicting disease recurrence in colorectal cancer?
Research has shown that adjuvant chemotherapy (ACT) is the standard treatment for stage II and III colorectal cancer (CRC) and can reduce the risk of recurrence. However, about 10-15% of stage II patients still experience a return of cancer within five years. This trial evaluates the CENSURE test for its ability to predict this risk by analyzing DNA changes that affect gene function. The test may help identify patients more likely to experience recurrence, enabling more personalized treatment plans. Although this technology is new, it has the potential to improve predictions of recurrence and enhance patient outcomes.12678
Who Is on the Research Team?
Ajay Goel, PhD
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Biomarker Discovery
Systematic and comprehensive CpG methylation-based epigenetic biomarker discovery phase to identify differentially methylated CpG sites associated with recurrence-free survival
Assay Development
Tissue-based clinical assay development phase by quantitative pyrosequencing
Validation
Independent validation phase to validate a tissue-based assay to predict the development of recurrence after chemotherapy
Follow-up
Participants are monitored for recurrence-free survival and overall survival after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CENSURE
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Stage II/III Colorectal Cancer patients who received treatment with surgery and adjuvant chemotherapy, and did not experience recurrence within five years.
Stage II/III Colorectal Cancer patients who received treatment with surgery and adjuvant chemotherapy, and did not experience recurrence within five years.
Stage II/III Colorectal Cancer patients who received treatment with surgery and adjuvant chemotherapy, and experienced recurrence within five years.
Stage II/III Colorectal Cancer patients who received treatment with surgery and adjuvant chemotherapy, and experienced recurrence within five years.
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
Citations
Recurrence Risk after Radical Colorectal Cancer Surgery ...
Several studies found that in stage II, the recurrence risk at 5 years was very low in most patients whereas a minor fraction (about 10–15%) had a higher ...
NCT06314958 | Stage II/III Colorectal Cancer Recurrence
Adjuvant chemotherapy (ACT) is the standard clinical care for patients with stage III or high-risk stage II colorectal cancer (CRC) after curative-intent ...
Adverse events of postoperative adjuvant chemotherapy ...
We analysed patient data from four Japanese randomised controlled trials on adjuvant chemotherapy for stage II or III colorectal cancer.
Incidence of Recurrence and Time to Recurrence in Stage I ...
For rectal cancer, the 5-year CIF decreased over the 3 periods from 19.9% to 9.5% for stage I, from 25.8% to 18.4% for stage II, and from 38.7% ...
5.
aacrjournals.org
aacrjournals.org/clincancerres/article/30/19/4377/748568/Colorectal-Cancer-Recurrence-Prediction-Using-aColorectal Cancer Recurrence Prediction Using a Tissue-Free ...
Forty-two percent of patients had rectal cancer, and 58% had colon cancer; 25% stage II, 68% stage III, and 7% clinical stage III/pathologic ...
Overall and stage-specific survival of patients with screen ...
Five-year overall and CRC-specific survival rates for patients with screen-detected cancer were 83·4% (95% CI 82·9-83·9) and 89·2% (88·8-89·7), respectively.
Enhanced risk stratification for stage II colorectal cancer ...
The training dataset included 1110 patients, the internal validation dataset included 477 patients, and the external validation dataset included ...
NCT05427669 | Adjuvant mFOLFOXIRI vs. mFOLFOX6 in ...
About 50% of patients can be cured with surgery alone. For colon cancer with high-risk stage II or III after surgery, the current guidelines recommend 3-6 ...
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