Collection of Samples USOPTIVAL Study

Part of paid clinical trials in Chula Vista, California.

Sponsor
Universal Diagnostics
Study ID
NCT04792684
Status
Recruiting
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Conditions

  • Advanced Adenomas (AA)
  • Colorectal Cancer (CRC)

Eligibility Criteria

Sex
ALL
Age
45 Years - 84 Years
Healthy Volunteers
Accepted

Interventions

  • Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel — DIAGNOSTIC_TEST
    Evaluate the performance of a preliminary panel of biomarkers

Study Details

A prospective multi-center observational study. The study will enroll eligible subjects from the United States to optimize the biomarker panel and evaluate the performance of a cfDNA marker panel selected by the Sponsor for CRC and advanced adenoma detection.

Key Dates

Start date
Dec 30, 2020
Status verified
Nov 2025
Primary completion
Dec 30, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
1,300 participants (estimated)

Arms

  • Arm: Arm A.
    Subjects that have a suspected advanced adenoma or have been newly diagnosed with CRC still not resected and scheduled for surgery
  • Arm: Arm B
    Subjects at average-risk for CRC and scheduled for CRC screening colonoscopy

Primary Outcome Measure

Samples Collected for Plasma Circulating Free-DNA (cfDNA) Marker Testing [ Time Frame: Within 12 months of sample collection ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
Precision Recearch InstituteChula VistaCalifornia91910-
Medical Associates Research GroupSan DiegoCalifornia92123-
Precision Research InstituteSan DiegoCalifornia92114-
Clinical Research of CaliforniaWalnut CreekCalifornia94598-
Center for Gastrointestinal DisordersHollywoodFlorida33021-
Lakeland Regional Cancer CenterLakelandFlorida33805
Manuel Molina
Springfield ClinicSpringfieldIllinois62702
Peter Hofmann
Ochsner ClinicNew OrleansLouisiana70121-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Mid Hudson Medical ResearchNew WindsorNew York12553
Sashi Makam
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
University of PennsylvaniaPhiladelphiaPennsylvania19104
Bryson Katona
Frontier Clinical ResearchUniontownPennsylvania15401-
Clinical Trials NetworkUnion CityTennessee38261-
Vilo Research GroupHoustonTexas77017-
Gastroenterology Consultants of SW VirginiaRaonokeVirginia24014-

Find similar trials in Chula Vista, CA

By research site
Precision Recearch Institute· Chula Vista, CAMedical Associates Research Group· San Diego, CAPrecision Research Institute· San Diego, CAClinical Research of California· Walnut Creek, CACenter for Gastrointestinal Disorders· Hollywood, FLLakeland Regional Cancer Center· Lakeland, FL

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