cfDNA Assay for Cancer Detection
(CAMPERR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to improve early cancer detection and monitor recurrence using the Genome-wide Methylome Enrichment Platform, which examines DNA changes linked to various cancer types. It focuses on a wide range of cancers, including brain, breast, and lung cancer, to determine if this method can identify cancer and predict relapses. The trial seeks individuals newly diagnosed with cancers like lung or breast cancer within the last 120 days or those who experienced a recurrence after more than five years. Participants should not currently receive cancer treatment or have any other invasive cancer diagnosed in the last five years. The study also seeks healthy participants without a cancer diagnosis in the past five years for comparison. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could revolutionize cancer detection and monitoring.
Will I have to stop taking my current medications?
If you are currently taking any demethylating agents or DNA hypomethylating agents, you will need to stop taking them to participate in the trial. Otherwise, the protocol does not specify if you need to stop other medications.
What prior data suggests that this genome-wide methylome enrichment platform is safe?
Research has shown that new methods for analyzing DNA changes in blood samples are promising in early studies. These methods examine DNA methylation patterns, chemical changes in DNA that can influence gene function, to help detect cancer.
In these studies, researchers have used this approach to differentiate between ovarian cancer and non-cancer cases. It has also been tested for detecting tiny amounts of cancer that might remain after treatment in patients with head and neck cancer. The studies found this method effective in identifying cancer signals.
Importantly, this method requires only a blood test, making it generally safe and non-invasive. So far, studies have reported no major safety concerns.
Overall, while this is a newer method and ongoing studies continue to explore its use, early findings suggest it is well-tolerated by people.12345Why are researchers excited about this trial?
Researchers are excited about the Genome-wide Methylome Enrichment Platform because it offers a new way to detect cancer early and monitor minimal residual disease. Unlike traditional methods that rely on imaging or invasive biopsies, this platform analyzes cell-free DNA (cfDNA) from a simple blood sample. By focusing on the methylation patterns across the genome, it aims to identify cancer presence and recurrence with greater precision. This non-invasive approach could lead to earlier interventions and more personalized treatment plans, potentially improving outcomes for patients.
What evidence suggests that this genome-wide methylome enrichment platform is effective for detecting multiple cancer types?
Research has shown that a new testing method, the Genome-wide Methylome Enrichment Platform, holds promise for early cancer detection. This method detects cancer DNA in the blood even in small quantities, which is common in early-stage cancers. By identifying DNA changes that signal cancer, it helps detect various cancer types. Early results indicate it can also track minimal residual cancer cells post-treatment and predict cancer recurrence before symptoms arise, particularly in lung cancer. This makes it a potentially powerful tool for cancer detection and monitoring.13678
Who Is on the Research Team?
Brian Rini, MD
Principal Investigator
Vanderbilt-Ingram Cancer 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
Baseline Assessment
All participants provide a blood sample and applicable clinical data at baseline
Follow-up
Participants with Tier 1 cancer have clinical follow-up and blood draws every 3 months for the first year after first-line treatment, and every 6 months for an additional 2 years. All other cases have clinical follow-up once a year for 3 years after enrollment. Control participants have clinical follow-up every 6 months for up to 3 years from enrollment.
What Are the Treatments Tested in This Trial?
Interventions
- Genome-wide Methylome Enrichment Platform
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alzheimer's Disease Expert Lab (ADEL), Inc.
Lead Sponsor
Adela, Inc.
Lead Sponsor
Adela, Inc
Lead Sponsor
Citations
1910P Evaluation of a genome-wide methylome ...
Here we demonstrate the feasibility of using a tumor-uninformed genome-wide methylome enrichment platform to quantify ctDNA in plasma and predict prognosis in ...
2.
aacrjournals.org
aacrjournals.org/cancerres/article/83/7_Supplement/1030/727034/Abstract-1030-Development-of-a-genome-wideAbstract 1030: Development of a genome-wide methylome ...
Conclusions: Initial analysis of case-control data demonstrates feasibility of a genome-wide methylome enrichment platform for MCED. The ...
3.
oncnursingnews.com
oncnursingnews.com/view/genome-wide-methylome-enrichment-testing-demonstrates-high-detection-rate-in-early-stage-cancers-with-limited-ctdnaGenome-Wide Methylome Enrichment Testing ...
A novel methylome-based test may help detect early-stage cancers with limited circulating tumor DNA (ctDNA), according to a poster presentation.
Clinical validation of a tissue-agnostic genome-wide ...
Outcomes for patients with locally advanced head and neck cancer (HNC) treated with curative intent remain disappointing, with 5-year survival rates at 50%.
Validation of an optimized tissue-agnostic genome-wide ...
Conclusions: A clinical tissue-agnostic, genome-wide methylome enrichment approach using cfMeDIP-seq accurately predicts clinical outcomes in ...
Genome-Wide cfDNA Methylation Profiling Reveals Robust ...
In this study, we analyzed cell-free DNA from blood samples to investigate whether DNA methylation patterns could distinguish ovarian cancer from benign ...
Performance characteristics of a tissue-agnostic genome ...
Here we present data using a tissue-agnostic, genome-wide methylome enrichment platform based on cell-free methylated DNA immunoprecipitation ...
Study Details | NCT05366881 | cfDNA Assay Prospective ...
This is an observational case-control study to train and validate a genome-wide methylome enrichment platform to detect multiple cancer types and to ...
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