Prospective Study to Assess a Diagnostic Aid for Cancer
Start Date
7/11/2025
Completion Date
11/1/2026
Summary
The primary objective of this study is to establish the performance of two blood-based diagnostic aid test for cancer detection in individuals presenting with symptoms, signs, or findings suggestive of cancer.
Detailed Description
Subjects 45 years of age and older presenting with symptoms, signs, and/or findings suggestive of one or more cancers originating from protocol-specified sites will be enrolled. Subjects will complete a blood draw for analysis by the investigational diagnostic aid test. For subjects with suspected cancer at enrollment, clinical outcomes will be determined following completion of a standard-of-care diagnostic work-up as clinically indicated. Subjects with a confirmed cancer diagnosis at enrollment must be treatment-naïve and will have diagnosis details collected at the time of enrollment. The results of the investigational diagnostic aid test will not be provided to investigators, treating clinicians, or subjects. Personnel performing clinical evaluations, determining final diagnoses, or reviewing diagnostic imaging and pathology reports will remain blinded to the results of the investigational test. All testing and associated analyses will be conducted in a blinded fashion, and test results will not inform clinical decision-making.
Eligibility Criteria
Age Range: 45 years to No maximum
Interventions
Blood sample collection
Conditions
Locations
Southern California Research Center
Coronado, California 92118
United States
Palomar Health
Poway, California 92064
United States
South Coast Gynecologic Oncology
San Diego, California 92108
United States
Rocky Mountain Gastroenterology
Centennial, Colorado 80112
United States
Zoyla Almeida, MD PA
Coconut Creek, Florida 33073
United States
Azzi ENT and Facial Reconstructive Surgery
Jupiter, Florida 33477
United States
Prophase, LLC
Margate, Florida 33063
United States
Millennium Medical Research
Miami, Florida 33126
United States
Regis Clinical Research
Miami, Florida 33126
United States
Gastroenterology of Greater Orlando
Orange City, Florida 32763
United States
Millennium Physician Group
Port Charlotte, Florida 33952
United States
Stuart Oncology Associates
Stuart, Florida 34994
United States
Avita Clinical Research
Tampa, Florida 33613
United States
Cancer Center of Middle Georgia
Dublin, Georgia 31021
United States
Pulmonary & Sleep Specialists of Northeast Georgia, P.C
Winder, Georgia 30680
United States
Christie Clinic
Champaign, Illinois 61820
United States
Hope and Healing Cancer Services
Hinsdale, Illinois 60521
United States
Iowa Clinic
West Des Moines, Iowa 50266
United States
Hutchinson Clinic
Hutchinson, Kansas 67502
United States
Northlake Gastroenterology Associates
Hammond, Louisiana 70403
United States
Velocity Clinical Research
Annapolis, Maryland 21401
United States
Capital Digestive Care
Chevy Chase, Maryland 20815
United States
Huron Gastroenterology
Ypsilanti, Michigan 48197
United States
Oncology Hematology Specialists
Mountain Lakes, New Jersey 07046
United States
Southwest Gastroenterology
Albuquerque, New Mexico 87109
United States
Westchester Putnam Gastro
Carmel, New York 10512
United States
Associated Gastroenterologists of Central New York
Fayetteville, New York 13066
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10021
United States
Wilmington Health, PLLC
Wilmington, North Carolina 28401
United States
Hightower Clinical
Oklahoma City, Oklahoma 73102
United States
Susquehanna Research Group
Harrisburg, Pennsylvania 17110
United States
Respiratory Specialists
Wyomissing, Pennsylvania 19610
United States
Cancer Care Associates of York
York, Pennsylvania 17403
United States
GIA Clinical Trials, LLC
Knoxville, Tennessee 37909
United States
Premier Family Physicians
Austin, Texas 78735
United States
Texas Digestive
Harlingen, Texas 78550
United States
Activian Clinical Research (Scarsdale)
Houston, Texas 77089
United States
Huntsville Research Institute, LLC
Huntsville, Texas 77340
United States
Activian Clinical Research
Kingwood, Texas 77339
United States