CfDNA Assay Prospective Observational Validation For Early Cancer Detection And Minimal Residual Disease (CAMPERR)
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 22-000686
NCT ID: NCT05366881
Sponsor Protocol Number: Adela-EDMRD-001
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.
Inclusion Criteria - Cancer Cases:
- 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.
Inclusion Criteria - Controls
- Not diagnosed with any cancer in the last 5 years:
- Non-invasive cancer (i.e. ductal carcinoma in situ or non-melanoma skin cancer) is allowed.
- Able and willing to provide informed consent.
- ≥ 40 years of age.
Exclusion Criteria - Cancer Cases:
- Currently receiving any treatment for cancer
- Preventative or long-term treatment (i.e. tamoxifen or extended endocrine therapy) is considered cancer treatment;
- Dietary or herbal supplements, statin, or aspirin regimens are not considered cancer treatment.
- Currently taking any demethylating agents/DNA hypomethylating agents (i.e., Vidaza, Decitabine).
- 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:
- Non-melanoma skin cancer is allowed;
- Participants whose index cancer is a recurrence of a previously diagnosed cancer are not eligible if the original cancer was diagnosed ≤ 5 years ago.
- Currently diagnosed with any chronic hematopoietic cancer (i.e., chronic CLL) in addition to the index cancer.
- Currently diagnosed with any myelodysplastic syndromes and/or precursor hematologic conditions (i.e., MGUS) in addition to the index cancer:
- Participants whose index cancer evolved from a precursor condition (i.e., AML evolved from MDS) are eligible.
- Women who are known to be pregnant (self-reported).
Exclusion Criteria - Controls:
- Currently receiving any treatment for cancer:
- Preventative treatment (i.e., tamoxifen or extended endocrine therapy) is considered cancer treatment;
- Dietary or herbal supplements, statin, or aspirin regimens are not considered cancer treatment.
- Currently taking any demethylating agents/DNA hypomethylating agents (i.e., Vidaza, Decitabine).
- Women who are known to be pregnant.
Eligibility last updated 1/20/22. 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.
More information
Publications
Publications are currently not available