Prospective Cohort Study With Case Enrichment to Assess a Diagnostic Aid for Cancer in Symptomatic Subjects (PROCARES)
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.
Arms & interventions
- OtherBlood sample collection
The study will collect up to 40 mL of whole peripheral blood in Streck Cell-Free DNA BCT® tubes from each participant.
Outcome measures
Primary
Performance of two diagnostic aid tests among individuals presenting with symptoms, signs and/or clinical findings suggestive of one or more cancers originating from the protocol-specified sites: a multi-cancer (MC) and gastrointestinal-focused (GI) test
* Predictive value of the Harbinger multi-cancer (MC) test by each readout category. * Predictive value of the Harbinger GI test by each readout category.
Time frame: 18 months
Secondary
Quantify test readout distribution, likelihood ratio, and marginal classification distribution of each Harbinger test
Time frame: 18 months
Establish cancer incidence in this intended use population
Time frame: 18 months
Eligibility criteria
Study locations (39)
Southern California Research Center
Coronado, California, 92118
Palomar Health
Poway, California, 92064
South Coast Gynecologic Oncology
San Diego, California, 92108
Rocky Mountain Gastroenterology
Centennial, Colorado, 80112
Zoyla Almeida, MD PA
Coconut Creek, Florida, 33073
Azzi ENT and Facial Reconstructive Surgery
Jupiter, Florida, 33477
Prophase, LLC
Margate, Florida, 33063
Millennium Medical Research
Miami, Florida, 33126
Regis Clinical Research
Miami, Florida, 33126
Gastroenterology of Greater Orlando
Orange City, Florida, 32763
Millennium Physician Group
Port Charlotte, Florida, 33952
Stuart Oncology Associates
Stuart, Florida, 34994
Avita Clinical Research
Tampa, Florida, 33613
Cancer Center of Middle Georgia
Dublin, Georgia, 31021
Pulmonary & Sleep Specialists of Northeast Georgia, P.C
Winder, Georgia, 30680
Christie Clinic
Champaign, Illinois, 61820
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521
Iowa Clinic
West Des Moines, Iowa, 50266
Hutchinson Clinic
Hutchinson, Kansas, 67502
Northlake Gastroenterology Associates
Hammond, Louisiana, 70403
Velocity Clinical Research
Annapolis, Maryland, 21401
Capital Digestive Care
Chevy Chase, Maryland, 20815
Huron Gastroenterology
Ypsilanti, Michigan, 48197
Oncology Hematology Specialists
Mountain Lakes, New Jersey, 07046
Southwest Gastroenterology
Albuquerque, New Mexico, 87109
Westchester Putnam Gastro
Carmel, New York, 10512
Associated Gastroenterologists of Central New York
Fayetteville, New York, 13066
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Wilmington Health, PLLC
Wilmington, North Carolina, 28401
Hightower Clinical
Oklahoma City, Oklahoma, 73102
Susquehanna Research Group
Harrisburg, Pennsylvania, 17110
Respiratory Specialists
Wyomissing, Pennsylvania, 19610
Cancer Care Associates of York
York, Pennsylvania, 17403
GIA Clinical Trials, LLC
Knoxville, Tennessee, 37909
Premier Family Physicians
Austin, Texas, 78735
Texas Digestive
Harlingen, Texas, 78550
Activian Clinical Research (Scarsdale)
Houston, Texas, 77089
Huntsville Research Institute, LLC
Huntsville, Texas, 77340
Activian Clinical Research
Kingwood, Texas, 77339