RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-05-03
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05366881

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Able and willing to provide informed consent
  3. * ≥40 years of age
  1. * Currently receiving any treatment for cancer
  2. * Currently taking any demethylating agents/DNA hypomethylating agents
  3. * Simultaneously diagnosed with two or more invasive cancers
  4. * Diagnosed with any invasive or non-invasive cancer in addition to the index cancer in the last 5 years
  5. * Currently diagnosed with any chronic hematopoietic cancer (e.g. chronic CLL) in addition to the index cancer
  6. * Currently diagnosed with any myelodysplastic syndromes and/or precursor hematologic conditions (e.g. MGUS) in addition to the index cancer
  7. * Women who are known to be pregnant (self-reported)
  8. * Not diagnosed with any cancer in the last 5 years (non-invasive cancer is allowed)
  9. * Able and willing to provide informed consent
  10. * ≥40 years of age
  11. * Currently receiving any treatment for cancer
  12. * Currently taking any demethylating agents/DNA hypomethylating agents
  13. * Women who are known to be pregnant (self-reported)

Contacts and Locations

Study Contact

Brian Allen, MS
CONTACT
203-514-4155
brian.allen@adelabio.com
Michelle Anderson
CONTACT
475-766-8183
michelle.anderson@adelabio.com

Principal Investigator

Brian Rini, MD
PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center

Study Locations (Sites)

City of Hope
Duarte, California, 91010
United States
Miami Cancer Institute
Miami, Florida, 33176
United States
North Georgia Health System
Gainesville, Georgia, 306501
United States
Baptist Floyd
New Albany, Indiana, 47150
United States
Baptist Corbin
Corbin, Kentucky, 40701
United States
Baptist Hardin
Elizabethtown, Kentucky, 42701
United States
Baptist Lexington
Lexington, Kentucky, 40503
United States
Baptist Paducah
Paducah, Kentucky, 42003
United States
Allina Health Cancer Institute
Minneapolis, Minnesota, 55407
United States
Mayo Clinic
Rochester, Minnesota, 55902
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Oregon Health Sciences University
Portland, Oregon, 97201
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
McLeod Health
Florence, South Carolina, 29502
United States
Baptist (BHMCC)
Memphis, Tennessee, 38120
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37203
United States
Elligo Health Research, Inc.
Austin, Texas, 78704
United States

Collaborators and Investigators

Sponsor: Adela, Inc

  • Brian Rini, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt-Ingram Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-03
Study Completion Date2027-03

Study Record Updates

Study Start Date2022-05-03
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • Multi-cancer early detection
  • Liquid Biopsy
  • Methylome
  • Cancer screening
  • cell-free DNA

Additional Relevant MeSH Terms

  • 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