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

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 four cancer types (breast, colorectal, lung, prostate). These cancers were 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

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Study Overview

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Study Details

Study overview

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 four cancer types (breast, colorectal, lung, prostate). These cancers were selected based on the existing clinical landscape and treatment availability.

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

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

Condition
Brain Cancer
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope, Duarte, California, United States, 91010

Miami

Miami Cancer Institute, Miami, Florida, United States, 33176

Gainesville

North Georgia Health System, Gainesville, Georgia, United States, 306501

New Albany

Baptist Floyd, New Albany, Indiana, United States, 47150

Corbin

Baptist Corbin, Corbin, Kentucky, United States, 40701

Elizabethtown

Baptist Hardin, Elizabethtown, Kentucky, United States, 42701

Lexington

Baptist Lexington, Lexington, Kentucky, United States, 40503

Paducah

Baptist Paducah, Paducah, Kentucky, United States, 42003

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55902

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Newly diagnosed (within 90 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
  • * 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)
  • * 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
  • * Currently receiving any treatment for cancer
  • * Currently taking any demethylating agents/DNA hypomethylating agents
  • * Women who are known to be pregnant (self-reported)

Ages Eligible for Study

40 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Adela, Inc,

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

Study Record Dates

2026-12