Status:
RECRUITING
cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
Lead Sponsor:
Adela, Inc
Conditions:
Brain Cancer
Breast Cancer
Eligibility:
All Genders
40+ years
Brief 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 inc...
Detailed 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 indi...
Eligibility Criteria
Inclusion
- Case
- 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
- 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)
Key Trial Info
Start Date :
May 3 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
7000 Patients enrolled
Trial Details
Trial ID
NCT05366881
Start Date
May 3 2022
End Date
December 1 2026
Last Update
February 20 2024
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
City of Hope
Duarte, California, United States, 91010
2
Miami Cancer Institute
Miami, Florida, United States, 33176
3
North Georgia Health System
Gainesville, Georgia, United States, 306501
4
Baptist Floyd
New Albany, Indiana, United States, 47150