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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 40 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Case

Inclusion 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.
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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05366881
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Adela, Inc
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Brian Rini, MD
Principal Investigator Affiliation Vanderbilt-Ingram Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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
Additional Details

This is an observational case-control study that includes individuals with cancer and individuals without known cancer. All participants will have clinical follow-up after enrollment. A subset of individuals with cancer will also have longitudinal blood sampling to evaluate the ability of the genome-wide methylome enrichment platform to detect minimal residual disease. This includes individuals with Stage I-III breast, colorectal, lung, or prostate cancer (Tier 1 Cancers). At baseline, all participants will provide a blood sample and applicable clinical data. Participants with a Tier 1 cancer will have clinical follow-up and blood draws after the completion of first-line treatment, every 3 months for the first year after first-line treatment, and every 6 months for an additional 2 years. All other cases will have clinical follow-up once a year for 3 years after enrollment. Control participants will have clinical follow-up every 6 months for up to 3 years from enrollment to evaluate cancer status. The blood test to be used in this study is a highly sensitive, epigenomic-based genome-wide methylome enrichment platform. The assay includes bisulfite-free, non-degradative genome-wide DNA methylation profiling from small quantities of cell-free DNA (cfDNA). Libraries constructed from cfDNA are enriched for methylated CpGs and preserve the native fragment length. This is followed by high throughput sequencing. For all assays, samples from participants with cancer and participants without cancer will be run together to reduce batch effects using methodology determined by the Sponsor. Results from the liquid biopsy test will not be returned to clinicians or participants.

Arms & Interventions

Arms

: Cases

Cases will include participants with newly diagnosed, treatment-naive cancer at the time of enrollment.

: Controls

Controls will include participants without known cancer at the time of enrollment.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

City of Hope, Duarte, California

Status

Recruiting

Address

City of Hope

Duarte, California, 91010

Site Contact

Xiao-Yu Xia

[email protected]

626-218-0630

Miami Cancer Institute, Miami, Florida

Status

Recruiting

Address

Miami Cancer Institute

Miami, Florida, 33176

Site Contact

Belkys Salinas

[email protected]

203-514-4155

North Georgia Health System, Gainesville, Georgia

Status

Recruiting

Address

North Georgia Health System

Gainesville, Georgia, 306501

Site Contact

Trena Davis

[email protected]

203-514-4155

Baptist Floyd, New Albany, Indiana

Status

Recruiting

Address

Baptist Floyd

New Albany, Indiana, 47150

Site Contact

Tasha Dodson

[email protected]

203-514-4155

Baptist Corbin, Corbin, Kentucky

Status

Recruiting

Address

Baptist Corbin

Corbin, Kentucky, 40701

Site Contact

Janie Platt

[email protected]

203-514-4155

Baptist Hardin, Elizabethtown, Kentucky

Status

Recruiting

Address

Baptist Hardin

Elizabethtown, Kentucky, 42701

Site Contact

Amy Steward

[email protected]

203-514-4155

Baptist Lexington, Lexington, Kentucky

Status

Recruiting

Address

Baptist Lexington

Lexington, Kentucky, 40503

Site Contact

Janie Platt

[email protected]

203-514-4155

Baptist Paducah, Paducah, Kentucky

Status

Withdrawn

Address

Baptist Paducah

Paducah, Kentucky, 42003

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55902

Site Contact

Angela R Emanuel

[email protected]

203-514-4155

Cleveland Clinic, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Site Contact

Mofetoluwa Oluwasanmi

[email protected]

216-444-0843

Oregon Health Sciences University, Portland, Oregon

Status

Recruiting

Address

Oregon Health Sciences University

Portland, Oregon, 97201

Site Contact

Diana Potts

[email protected]

203-514-4155

McLeod Health, Florence, South Carolina

Status

Recruiting

Address

McLeod Health

Florence, South Carolina, 29502

Site Contact

Betsy Harris

[email protected]

203-514-4155

Baptist (BHMCC), Memphis, Tennessee

Status

Recruiting

Address

Baptist (BHMCC)

Memphis, Tennessee, 38120

Site Contact

Tracy Stewart

[email protected]

203-514-4155

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37203

Site Contact

Anna Dumont

[email protected]

203-514-4155

Elligo Health Research, Inc., Austin, Texas

Status

Recruiting

Address

Elligo Health Research, Inc.

Austin, Texas, 78704

Site Contact

Cynthia Currasco

[email protected]

203-514-4155

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