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

Launched by ADELA, INC · May 5, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to detect different types of cancer early and to check if there is any remaining cancer after treatment. Researchers are using a special test that examines DNA changes in the body to see if they can identify cancers like breast, lung, and prostate, among others. The study aims to help doctors find cancer sooner and monitor patients for any signs of returning cancer after treatment.

To participate, individuals need to be at least 40 years old and either newly diagnosed with one of the specified cancers or have had a recurrence of a cancer diagnosed more than five years ago. However, those currently undergoing cancer treatment or taking certain medications cannot join. Participants will provide samples for the DNA test and will help researchers learn more about how to improve cancer detection and care. This study is important because it could lead to better tools for managing cancer, potentially improving outcomes for many patients.

Gender

ALL

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)