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A Bio-bank for Patients with Inflammatory Bowel Disease Associated Neoplasia
Rochester, MN
The purpose of this study is to collect blood and stool samples to validate and improve the performance of stool and blood DNA markers for inflammatory bowel disease and colorectal neoplasia critical to the long-term goal of improving effectiveness of neoplasia detection in patients using non-invasive biomarkers to assist colonoscopy and radiographic screening.
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A Novel Molecular Approach To Blood DNA Screening For Cancer: Specificity Assessment (The NOMAD Study)
Rochester, MN
The primary aim of this study is to evaluate the distribution of marker levels determined by this multi-marker, multi-compartment blood DNA test approach across persons without known cancer or precancer.
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Bladder Bank
Rochester, MN
The purpose of this study is to establish samples (blood and urine) to support the development of non-invasive tests for early detection of bladder cancer
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Colon Bank
Rochester, MN
The purpose of this study is to establish a biobank of samples (blood and stool) to support the development of non-invasive tests for early detection of colon cancer and its precursors.
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IDENTIFICATION OF METHYLATED DNA MARKERS IN INVASIVE BLADDER CARCINOMA: WHOLE METHYLOME DISCOVERY, TISSUE VALIDATION, AND FEASIBILITY TESTING IN BLOOD AND URINE
Rochester, MN
The purpose of this study is to, in tissue, discover and validate DNA methylation markers (MDMs) for detection of invasive urothelial carcinoma of the bladder. In blood, to assess the accuracy of candidate MDMs from above for detection of invasive urothelial carcinoma of the bladder. In urine, to explore the accuracy of candidate MDMs from above for detection of invasive urothelial carcinoma of the bladder. Diagnostic accuracy on urine can be compared with that on plasma using paired samples.
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Validation Of DNA Methylation Markers For The Universal And Site-Specific Guided Cancer Detection (the VANGUARD Study)
Rochester, MN
This study explores the potential value of a new blood test approach for early detection of cancer.
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Minimally Invasive Molecular Approaches For The Diagnosis Of Barrett's Esophagus And Esophageal Adenocarcinoma- R01 Aim 1a Renewal (SOS5C Trial)
Scottsdale/Phoenix, AZ
Eau Claire, WI
Rochester, MN
This clinical trial studies how well minimally invasive approaches (an artificial intelligence \[AI\] powered risk tool, nurse navigation, and a sponge on a string \[SOS\] test) work in diagnosing patients with Barrett's esophagus (BE) and esophageal cancer. Esophageal cancer has a poor 5-year survival rate when diagnosed after onset of symptoms. While rising, incidence of esophageal cancer remains too low to screen the entire population. BE is a condition in which the cells lining the lower part of the esophagus have changed or been replaced with abnormal cells that could lead to esophageal cancer. Currently, patients are screened for BE based on certain risk factors (reflux, age \> 50 years, White race, family history of esophageal cancer, obesity, male sex, and smoking), followed by endoscopies and surgery for treatment. These standard procedures may result in under-recognition of BE risk due to inaccurate and difficult to use risk assessment tools, high cost, invasiveness, low access to endoscopy, and sub-optimal recognition of abnormal cells during routing endoscopy. An AI powered risk tool that integrates symptoms, health history, and laboratory values from electronic health record data may more accurately assess BE and esophageal cancer risk that manual assessment. The BE-SOS screening test combines a swallowable cell collection device with assessment of DNA, which may more accurately diagnose abnormal cells. Nurse navigation involves trained personnel assisting individuals through the screening process and completing the follow-up diagnostic test if the screening test is positive. Navigators address cultural, social, access, and logistical barriers to screening. Nurse navigation may increase completion rates of diagnostic procedures following a positive screening test. These minimally invasive approaches may enable higher rates of BE screening than currently being accomplished.
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Value Of Peritoneal-Lavage Methylated DNA Markers In Gastric Cancer (VALENCE)
Rochester, MN
The purpose of this study is to establish a biobank of samples (peritoneal fluid and blood) to support the development of non-invasive tests for the detection and recurrence of gastric cancer.
Closed for Enrollment
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An Evaluation Of A Multi-target Stool DNA (Mt-sDNA) Test, Cologuard, For CRC Screening In Individuals Aged 45-49 And At Average Risk For Development Of Colorectal Cancer
Scottsdale/Phoenix, AZ
Rochester, MN
The primary purpose of this study is to confirm the specificity of a multi-target stool DNA test, Cologuard, in an average risk population, ages 45-49.
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Blood And Stool Sample Collection In Subjects Participating In Colorectal Cancer Screening: Act Bold
Rochester, MN
The primary objective of this study is to collect de-identified, clinically-characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of colorectal cancer (CRC).
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Clinical Validation Of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, For Colorectal Cancer Screening BLUE-C
Scottsdale/Phoenix, AZ
Rochester, MN
The primary purpose of this study is to assess the sensitivity for colorectal cancer (CRC) and specificity of the mt-sDNA 2.0 test.
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Compartmentalization Of Circulating Nucleic Acid Tumor Markers In Blood: An Exploratory Study
Rochester, MN
The purpose of this study is to assess for the circulating nucleic acid tumor markers dispersed in the various components of blood samples from patients with proven cancer.
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Detecting Cancers Earlier Through Elective Plasma-based CancerSEEK Testing – Ascertaining Serial Cancer Patients To Enable New Diagnostic II (DETECT-ASCEND 2)
Albert Lea, MN
Scottsdale/Phoenix, AZ
Eau Claire, WI
La Crosse, WI
Mankato, MN
Rochester, MN
The purpose of this study is to obtain clinically characterized, whole blood specimens from participants with new or suspected diagnosis of (cancer subjects) and from participants who do not have a diagnosis of cancer (healthy subjects) to develop and refine assays for cancer in the blood
The primary objective of this study is to obtain clinically characterized, whole blood specimens from cancer and healthy subjects to develop and refine assays for cancer in the blood.
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Detection Of Advanced Colorectal Neoplasia By Stool DNA In Inflammatory Bowel Disease: OCEANIA Study
Rochester, MN
The purpose of this study is to determine the performance of the Exact IBD-ACRN (inflammatory bowel disease-advanced colorectal neoplasia)surveillance test to detect colorectal cancer (CRC) and colorectal neoplasia in patients with inflammatory bowel disease. Enrolled subjects must have undergone colonoscopy no more than 90 days prior to enrollment, will collect a stool sample for the surveillance test and then must undergo colonoscopy or surgical intervention within 120 days after enrollment.
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Detection Of Colorectal Cancer Or Advanced Neoplasia By Stool DNA In Lynch Syndrome: CORAL Study
Scottsdale/Phoenix, AZ
Jacksonville, FL
Rochester, MN
The purpose of this study is to to determine the sensitivity and specificity of a second-generation multi-target stool DNA test (mt-sDNA 2.0) (Cologuard 2.0®, Exact Sciences Corporation) for colorectal neoplasia (CRN) in subjects with Lynch syndrome.
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Detection Of Esophageal Cancer By Assay Of Novel Methylated DNA Markers In Plasma, A Phase II Study
Rochester, MN
The purpose of the study is to see if the plasma assay of MDMs using optimized markers and analytically sensitive assays will detect early-stage esophageal cancer at high specificity.
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Discovery and Validation of Non-Invasive Markers of Inflammatory Bowel Disease Severity
Rochester, MN
The purpose of this study is to identify blood cell-specific DNA methylation and micro RNA markers in tissue and stool samples in patients wiht inflammatory bowel disease.
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DNA Methylation In Adenocarcinoma Of The Prostate: Analysis Of Validated Biomarkers In Urine
Rochester, MN
The purpose of this study is to assess the accuracy of DNA marker candidates (individually and in combination) assayed from urine and prostatic fluid (collected following digital prostate massage) for detection of prostate cancer.
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Impact of Food Ingestion on Circulating DNA
Rochester, MN
The research is being done to explore the potential impact of food ingestion on circulating DNA levels in the blood.
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Long-Term Follow-up Of Patients At Average Risk For Colorectal Cancer – The Long-Haul Study
Rochester, MN
The purpose of this study is to assess the long term clinical outcomes of patients who had a false positive stool DNA test for colorectal cancer.
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Magnitude And Prediction Of Epigenetic Field Cancerization In Colitis-Associated Neoplasia
Rochester, MN
The purpose of the study is to:
- Map and compare the neoplasia-associated epigenetic field in IBD-CRN, sporadic CRN and controls.
- Measure sensitivity of DNA methylation for the detection of synchronous IBD-CRN as a complement or alternative to histologic diagnosis of dysplasia on random biopsies.
- Measure the density and types of lymphocytes infiltrating IBD-CRN tumors, sporadic tumors and the epigenetic field.
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Novel Molecular Blood Screening For Lung Cancer Feasibility Assessment (The NOBLE Study)
Rochester, MN
The purpose of this study is to assess Methylated DNA tumor markers distributed in blood samples of patients newly diagnosed with different types of lung cancer. The goal is to develop new blood screening tests that can identify the type and primary site of cancer.
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