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RECRUITING

cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease

NCT05366881 · View on ClinicalTrials.gov ↗

Study Summary

This is an observational case-control study to train and validate a genome-wide methylome enrichment platform to detect multiple cancer types and to differentiate amongst cancer types. The cancers included in this study are brain, breast, bladder, cervical, colorectal, endometrial, esophageal, gastric, head and neck, hepatobiliary, leukemia, lung, lymphoma, multiple myeloma, ovarian, pancreatic, prostate, renal, sarcoma, and thyroid. These cancers were selected based on their prevalence and mortality to maximize impact on clinical care. Additionally, the ability of the whole-genome methylome enrichment platform to detect minimal residual disease after completion of cancer treatment and to detect relapse prior to clinical presentation will be evaluated in lung cancer. This cancer was selected based on the existing clinical landscape and treatment availability.

Study Locations (17)

Kentucky

  • Baptist Corbin — Corbin
  • Baptist Hardin — Elizabethtown
  • Baptist Lexington — Lexington
  • Baptist Paducah — Paducah

Minnesota

  • Allina Health Cancer Institute — Minneapolis
  • Mayo Clinic — Rochester

South Carolina

  • Medical University of South Carolina — Charleston
  • McLeod Health — Florence

Tennessee

  • Baptist (BHMCC) — Memphis
  • Vanderbilt-Ingram Cancer Center — Nashville

California

  • City of Hope — Duarte

Florida

  • Miami Cancer Institute — Miami

Georgia

  • North Georgia Health System — Gainesville

Indiana

  • Baptist Floyd — New Albany

Trial Details

FieldValue
Enrollment Target 7,000 participants
Start Date 2022-05-03
Est. Completion 2027-03

Sponsor

Adela

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05366881

The ClinicalTrials.gov registry entry for NCT05366881 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 7,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Adela, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Breast Cancer appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05366881 reports 17 study locations spanning 11 distinct geographic areas — top geographies include Kentucky, Minnesota, South Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05366881 about?

NCT05366881 is a clinical study titled "cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease". This is an observational case-control study to train and validate a genome-wide methylome enrichment platform to detect multiple cancer types and to differentiate amongst cancer types. The cancers included in this study are brain, breast, bladder, cervical, colorectal, endometrial, esophageal, gastr...

What is the current status of trial NCT05366881?

This trial is currently recruiting. The enrollment target is 7,000 participants. The study started on 2022-05-03. Estimated completion is 2027-03.

What conditions does trial NCT05366881 study?

This clinical trial studies the following conditions: Breast Cancer, Colorectal Cancer, Head and Neck Cancer, Endometrial Cancer, Bladder Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

Who is sponsoring clinical trial NCT05366881?

This trial is sponsored by Adela, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05366881 being conducted?

This trial has 17 study locations across California, Florida, Georgia, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial