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Recruiting

Baptist Health Lexington

Arvinda Padmanabhan

Principal Investigator

Mina Rodgers

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Overview:

Adela CAMPERR: cfMeDIP-seq Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse (CAMPERR).

Learn more at ClinicalTrials.gov.

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.
Eligibility Criteria

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)