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

Overview

About this study

The purpose of this multicenter prospective observational case-control study is to train and validate Adela’s cfMeDIP-seq based methylome profiling platform to detect and differentiate multiple cancer subtypes. In addition, this study includes longitudinal follow-up for a subset of participants to train and validate the methylome profiling platform to detect minimal residual disease and recurrence.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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).

Eligibility last updated 9/26/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Lisa Boardman, M.D.

Open for enrollment

Contact information:

Angela Emanuel M.H.S.A.

(507) 293-0916

Emanuel.Angela@mayo.edu

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions