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

Adela, Inc · NCT05366881

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 40+ · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
7000
US sites recruiting
16
Study start
May 3, 2022
Record last updated
January 20, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Conditions: Brain Cancer; Breast Cancer; Bladder Cancer; Cervical Cancer; Colorectal Cancer; Endometrial Cancer; Esophageal Cancer; Stomach Cancer; Head and Neck Cancer; Hepatobiliary Cancer; Leukemia; Lung Cancer; Lymphoma; Multiple Myeloma; Ovarian Cancer; Pancreatic Cancer; Prostate Cancer; Renal Cancer; Sarcoma; Thyroid Cancer

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Case Inclusion Criteria

  • Newly diagnosed (within 120 days) with cancer or a recurrence of a cancer diagnosed >5 years ago of one of the following subtypes: Invasive Brain, Breast, Bladder, Cervical, Colorectal, Endometrial, Esophageal, Gastric, Head and Neck, Hepatobiliary, Lung, Ovarian, Pancreatic, Prostate, Renal, Sarcoma, Thyroid; Leukemia, Lymphoma, Multiple Myeloma
  • Able and willing to provide informed consent
  • ≥40 years of age

Case Exclusion Criteria

  • Currently receiving any treatment for cancer
  • Currently taking any demethylating agents/DNA hypomethylating agents
  • Simultaneously diagnosed with two or more invasive cancers
  • Diagnosed with any invasive or non-invasive cancer in addition to the index cancer in the last 5 years
  • Currently diagnosed with any chronic hematopoietic cancer (e.g. chronic CLL) in addition to the index cancer
  • Currently diagnosed with any myelodysplastic syndromes and/or precursor hematologic conditions (e.g. MGUS) in addition to the index cancer
  • Women who are known to be pregnant (self-reported)

Control Inclusion Criteria

  • Not diagnosed with any cancer in the last 5 years (non-invasive cancer is allowed)
  • Able and willing to provide informed consent
  • ≥40 years of age

Control Exclusion Criteria

  • Currently receiving any treatment for cancer
  • Currently taking any demethylating agents/DNA hypomethylating agents
  • Women who are known to be pregnant (self-reported)

Recruiting US locations

  • City of Hope

    Duarte, CA 91010

    Site contact: Xiao-Yu Xia · 626-218-0630 · xxia@coh.org

  • Miami Cancer Institute

    Miami, FL 33176

    Site contact: Belkys Salinas · Belkys.salinas@baptisthealth.net

  • North Georgia Health System

    Gainesville, GA 306501

    Site contact: Trena Davis · Trena.Davis@nghs.com

  • Baptist Floyd

    New Albany, IN 47150

    Site contact: Tasha Dodson · tasha.dodson@bhsi.com

  • Baptist Corbin

    Corbin, KY 40701

    Site contact: Janie Platt · Janie.Platt@bhsi.com

  • Baptist Hardin

    Elizabethtown, KY 42701

    Site contact: Amy Steward · amy.steward@bhsi.com

  • Baptist Lexington

    Lexington, KY 40503

    Site contact: Janie Platt · Janie.Platt@bhsi.com

  • Allina Health Cancer Institute

    Minneapolis, MN 55407

    Site contact: Jonathon Alexander · 612-863-8625 · jonathan.alexander@allina.com

  • Mayo Clinic

    Rochester, MN 55902

    Site contact: Angela R Emanuel · emanuel.angela@mayo.edu

  • Cleveland Clinic

    Cleveland, OH 44195

    Site contact: Mofetoluwa Oluwasanmi · 216-444-0843 · oluwasm@ccf.org

  • Oregon Health Sciences University

    Portland, OR 97201

    Site contact: Diana Potts · pottsd@ohsu.edu

  • Medical University of South Carolina

    Charleston, SC 29425

    Site contact: Michael Balassone · 843-792-6696 · balassom@musc.edu

  • McLeod Health

    Florence, SC 29502

    Site contact: Betsy Harris · bharris@mcleodhealth.org

  • Baptist (BHMCC)

    Memphis, TN 38120

    Site contact: Tracy Stewart · tracy.stewart2@bmhcc.org

  • Vanderbilt-Ingram Cancer Center

    Nashville, TN 37203

    Site contact: Anna Dumont · anna.dumont@vumc.org

  • Elligo Health Research, Inc.

    Austin, TX 78704

    Site contact: Cynthia Currasco · cynthia.currasco@elligodirect.com

Study contacts (from the official record)

  • Brian Allen, MS · 203-514-4155 · brian.allen@adelabio.com
  • Michelle Anderson · 475-766-8183 · michelle.anderson@adelabio.com
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cfDNA Assay Prospective Observational Validation for Early Cancer… (NCT05366881) | Bored Studies