Blood Test for Cancer Detection
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new blood test that could help detect cancer early. Researchers will collect blood, urine, and tissue samples to identify DNA changes that might indicate cancer. The trial includes individuals diagnosed with cancer who can provide samples, as well as those without cancer for a control group. Ideal candidates have had a biopsy confirming their cancer diagnosis and have not recently undergone major cancer treatments like chemotherapy.
As a Phase 2 trial, this research measures the test's effectiveness in an initial, smaller group, allowing participants to contribute to advancements in early detection.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, it does exclude participants who have received chemotherapy drugs in the past 5 years, so it's best to discuss your specific medications with the trial team.
What prior data suggests that this blood test is safe for cancer detection?
Research has shown that DNA methylation markers could be a useful tool for early cancer detection. In several studies, researchers tested these markers using blood samples and found them to be accurate. For instance, one study found that these markers correctly identified 88.1% of gastrointestinal (GI) cancers, which are often difficult to detect early, and avoided false alarms 91.2% of the time.
These studies not only focused on accuracy but also suggested that using DNA methylation markers is generally safe. Since the tests use blood samples, they are non-invasive, avoiding surgery or other potentially harmful procedures. So far, no significant negative effects have been reported in the reviewed studies, indicating that this approach is well-tolerated and safe for participants.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores the use of DNA methylation markers for detecting cancer, which could revolutionize early cancer detection. Unlike traditional methods that often rely on imaging or invasive biopsies, this approach aims to identify cancer through a simple blood, urine, or tissue sample, making it much less invasive. This method could potentially allow for universal and site-specific cancer detection, offering a more precise and comprehensive way to catch cancer early, which is crucial for effective treatment and better outcomes.
What evidence suggests that this blood test is effective for cancer detection?
Research has shown that certain changes in DNA, known as DNA methylation markers, are promising tools for early cancer detection. DNA methylation, a chemical change to DNA, can affect gene function and plays a crucial role in cancer development. Studies have found that these markers can distinguish between cancerous and non-cancerous cells. They are already used to diagnose some cancers, such as breast cancer. Early research suggests that using these markers in blood tests could enable earlier cancer diagnosis, potentially leading to better patient outcomes. Participants in this trial will provide blood, urine, and/or residual tissue samples to validate these DNA methylation markers for cancer detection.678910
Who Is on the Research Team?
John B. Kisiel, M.D.
Principal Investigator
Mayo Clinic in Rochester
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
Sample Collection
Patients undergo blood, urine, and/or residual tissue sample collection and have their medical records reviewed
Analysis
Samples are assayed for methylated DNA markers (MDMs) and RNA to identify individual organ sites of primary tumors
Follow-up
Participants are monitored for accuracy of test results based on review of past, present, and future medical record information
What Are the Treatments Tested in This Trial?
Interventions
- Validation of DNA Methylation Markers
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients undergo blood, urine, and/or residual tissue sample collection and have their medical records reviewed on study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Citations
An overview of DNA methylation markers for early ...
DNA methylation plays a key role in cancer progression and metastasis and has been demonstrated as a promising marker for cancer early detection ...
Methylation biomarkers for early cancer detection and ...
This review provides a brief exposition of current methylation biomarkers for cancer diagnosis and early detection, including markers already in clinical use ...
3.
breast-cancer-research.biomedcentral.com
breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-025-02066-xDiscovery and validation of cell-free DNA methylation markers ...
We aimed to identify specific methylation markers for diagnosis, differentiation from benign tumors, and prognosis of breast cancer (BC)
Development and validation of a methylation-specific ...
In this study, we developed and validated a methylation-specific droplet digital PCR (ddPCR) multiplex assay with five tumour-specific ...
Identification and validation of novel DNA methylation markers ...
Aberrant DNA methylation plays an important role in cancers and has shown to be a potential biomarker for the early detection of cancer.
Discovery and validation of tissue-specific DNA ...
We report the discovery and validation of a panel of methylation-based markers that specifically detect CRC.
Clinical validation of a multi-model blood cfDNA ...
SPOGIT demonstrated high accuracy in detecting GI cancers, with a sensitivity of 88.1 % and a specificity of 91.2 %. Notably, it effectively ...
Clinical validation of peripheral blood mononuclear cell ...
Examining cancer-specific DNA methylation markers in Circulating tumor DNA (ctDNA) is currently proposed as a preferred method for early ...
9.
aacrjournals.org
aacrjournals.org/clincancerres/article/25/24/7396/82351/Discovery-Validation-and-Application-of-NovelDiscovery, Validation, and Application of Novel Methylated ...
Methylated DNA markers (MDM) assayed from plasma show promise in detection of other cancers. For esophageal cancer detection, we aimed to discover and validate ...
Discovery and validation of novel methylated DNA markers ...
Results: From RRBS discovery and technical validation via MSP, 30 candidate MDMs showed marked methylation fold changes (10 to >1000) across both CC histologies ...
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