DENEB for Colorectal Cancer
(AACRC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial develops a new blood test to detect colorectal cancer and advanced adenomas (pre-cancerous growths) early. Researchers employ machine learning and advanced biology to enhance the test's accuracy and affordability. The trial includes several groups: individuals with colorectal cancer, those with high-risk adenomas, those with low-risk adenomas, and those without disease. Ideal participants have recently undergone a colonoscopy and received a diagnosis of one of these conditions. As an unphased trial, this study provides participants the chance to contribute to groundbreaking research that could lead to early detection methods for colorectal cancer.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the DENEB treatment uses a special blood test to help detect colorectal cancer. In a study with 208 patients with this type of cancer, only 13.3% experienced major problems, indicating that most patients tolerate the treatment well. Additionally, DENEB is undergoing testing in other studies, suggesting it appears safe so far. It's important to note that DENEB remains under study, so while early results are promising, further research will provide more information about its safety.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to enhance early detection of advanced adenomas and colorectal cancer using a unique cohort-based approach. Unlike traditional methods, this trial segments participants into discovery, training, and validation cohorts to refine diagnostic accuracy. This method not only aids in identifying colorectal cancer but also differentiates between low-risk and high-risk adenomas, potentially leading to earlier and more precise interventions. By focusing on early detection and accurate classification, the trial could significantly improve patient outcomes compared to standard diagnostic procedures like colonoscopy alone.
What evidence suggests that this treatment could be effective for early detection of colorectal cancer?
Studies have shown that DENEB, a liquid biopsy test, effectively detects colorectal cancer and advanced adenomas. Research indicates that analyzing small pieces of tumor DNA in the blood can identify cancer-related changes. This analysis successfully predicts whether cancer has spread to the lymph nodes, crucial for early detection. In one study, 166 out of 208 colorectal cancer patients were eligible for DENEB testing, demonstrating promising potential for early intervention. By detecting cancer earlier, DENEB aims to improve outcomes and prevent recurrence.13467
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
Genome-wide profiling of cf-miRNA and exo-miRNA and selecting the best candidates for biomarker panels
Algorithm Development
Utilizing machine learning to identify promising candidates and train algorithms for detecting AAs and CRC separately
Validation
Independently validating detection signatures using diverse cohorts to ensure broad applicability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- DENEB
How Is the Trial Designed?
12
Treatment groups
Experimental Treatment
Individuals who underwent colonoscopy and were found not to have any adenomas or cancer.
Individuals who underwent colonoscopy and were found not to have any adenomas or cancer.
Individuals who underwent colonoscopy and were found not to have any adenomas or cancer.
Individuals who underwent colonoscopy and were found to only have low-risk adenomas, defined as: * 1 to 4 adenomas at most. * All adenomas have low-grade dysplasia at most. * All adenomas are \<10 mm in diameter.
Individuals who underwent colonoscopy and were found to only have low-risk adenomas, defined as: * 1 to 4 adenomas at most. * All adenomas have low-grade dysplasia at most. * All adenomas are \<10 mm in diameter.
Individuals who underwent colonoscopy and were found to only have low-risk adenomas, defined as all of the following: * 1 to 4 adenomas at most. * All adenomas have low-grade dysplasia at most. * All adenomas are \<10 mm in diameter
Individuals who underwent colonoscopy and were found to have colorectal cancer.
Individuals who underwent colonoscopy and were found to have colorectal cancer.
Individuals who underwent colonoscopy and were found to have colorectal cancer.
Individuals who underwent colonoscopy and were found to have high-risk adenomas, defined as one or more of the following: * 5 or more adenomas. * One or more adenomas have high-grade dysplasia. * One or more adenomas are \>10 mm in diameter.
Individuals who underwent colonoscopy and were found to have high-risk adenomas, defined as one or more of the following: * 5 or more adenomas. * One or more adenomas have high-grade dysplasia. * One or more adenomas are \>10 mm in diameter.
Individuals who underwent colonoscopy and were found to have high-risk adenomas, defined as one or more of the following: * 5 or more adenomas. * One or more adenomas have high-grade dysplasia. * One or more adenomas are \>10 mm in diameter
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
Citations
DENEB: Development of a new criteria for curability after ...
DENEB: Development of a new criteria for curability after local excision of pathological T1 colorectal cancer using liquid biopsy. Expand Fullscreen Exit ...
DENEB: Development of new criteria for curability after ...
The aim of this study is to explore the ability of predicting LNM using ctDNA analysis compared with the standard pathological criteria.
Association of circulating tumor DNA (ctDNA) molecular ...
Results: Of 208 CRC patients enrolled between July 2021 and May 2023 in DENEB, 166 patients met the inclusion criteria. Of these, 22 (13.3%) ...
NCT06342440 | Early Detection of Advanced Adenomas ...
This study aims to develop a highly sensitive, specific, and cost-effective liquid biopsy for early detection of AAs and CRC. Success could transform clinical ...
(PDF) DENEB: Development of new criteria for curability ...
Despite standard-of-care treatment, more than 30% of patients with resectable colorectal cancer (CRC) relapse. Circulating tumor DNA (ctDNA) ...
DENEB: Development of new criteria for curability after ...
Based on the CIRCULATE-Japan platform, we launched DENEB, a new prospective study, within the GALAXY study for patients with pT1 colorectal ...
Current Progress in Clinical Research in Secondary ...
This review presents an overview of the current trends in clinical research related to secondary prevention of CRC.
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