Breast Cancer Clinical Trial

cfMeDIP-seq Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease

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

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Full Description

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.

View Eligibility Criteria

Eligibility 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)

Study is for people with:

Breast Cancer

Estimated Enrollment:

5280

Study ID:

NCT05366881

Recruitment Status:

Recruiting

Sponsor:

Adela, Inc.

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There are 7 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States More Info
Xiao-Yu Xia
Contact
626-218-0630
[email protected]
Gregory Idos, MD
Principal Investigator
Mayo Clinic
Rochester Minnesota, 55902, United States More Info
Angela R Emanuel
Contact
[email protected]
Lisa A Boardman, MD
Principal Investigator
Cleveland Clinic
Cleveland Ohio, 44195, United States More Info
Mofetoluwa Oluwasanmi
Contact
216-444-0843
[email protected]
Peter Mazzone, MD, MPH
Principal Investigator
Oregon Health Sciences University
Portland Oregon, 97201, United States More Info
Diana Potts
Contact
[email protected]
Nima Nabavizadeh, MD
Principal Investigator
Baptist Cancer Center
Memphis Tennessee, 38120, United States More Info
Tracy Stewart
Contact
Philip Lammers, MD
Principal Investigator
Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37203, United States More Info
Anna Dumont
Contact
[email protected]
Brian Rini, MD
Principal Investigator
Elligo Health Research, Inc.
Austin Texas, 78738, United States More Info
Whitney Kuang
Contact
[email protected]
Faith Holmes, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

5280

Study ID:

NCT05366881

Recruitment Status:

Recruiting

Sponsor:


Adela, Inc.

How clear is this clinincal trial information?

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