Prospective Study to Assess a Diagnostic Aid for Cancer
NCT ID: NCT07046260
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1650 participants
OBSERVATIONAL
2025-07-11
2027-05-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Patients with clinical suspicion of cancer or patients recently diagnosed with Cancer
People who have signs, symptoms, and/or findings that their doctor suspects may be related to cancer, or who have recently been diagnosed with cancer and have not received treatment for this cancer.
Blood sample collection
The study will collect up to 40 mL of whole peripheral blood in Streck Cell-Free DNA BCT® tubes from each Subject.
Interventions
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Blood sample collection
The study will collect up to 40 mL of whole peripheral blood in Streck Cell-Free DNA BCT® tubes from each Subject.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Provided written or electronic informed consent, according to local guidelines, signed and dated by the Subject or by a legal guardian prior to the performance of any study- specific procedures, sampling, or analyses
3. Presentation with symptoms, signs, and/or findings that raise clinical suspicion of one or more of the protocol-specified sites AND
1. undergoing diagnostic work-up to determine if cancer is present, but do not yet have a confirmed cancer diagnosis. Subject must be willing to undergo a standard diagnostic work-up per local SoC to establish clinical truth regarding the presence or absence of cancer OR
2. have a confirmed diagnosis of cancer, determined within 45 days prior to signing the Informed Consent Form, based on standard diagnostic procedures (histopathology, imaging, etc.) following presentation with symptoms, signs, and/or findings that raised a clinical suspicion of one or more cancers originating from the protocol-specified sites. Must be treatment-naïve for the diagnosed cancer at the time of enrollment.
Exclusion Criteria
2. Subject is suffering from any febrile illness defined as a temperature \>101.5°F within the last 48 hours
3. Subject is pregnant (Self-reported)
4. Subject is a recipient of an organ transplant, blood transfusion within 120 days, or prior non-autologous (allogeneic) bone marrow or stem cell transplant (Subject with a corneal transplant can be considered for study entry)
5. Inability or unwillingness to comply with study procedures or follow-up requirement
6. Previous or current participation in any study sponsored by, or employment with, Harbinger Health
7. Participation in a clinical research study sponsored by an external organization which may interfere with study procedures or outcomes
8. Subject has any condition that in the opinion of the Investigator should preclude participation in the study
45 Years
ALL
No
Sponsors
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Harbinger Health
INDUSTRY
Responsible Party
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Principal Investigators
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Luke Pike, MD, DPhil
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Palomar Health
Poway, California, United States
Rocky Mountain Gastroenterology
Centennial, Colorado, United States
Zoyla Almeida, MD PA
Coconut Creek, Florida, United States
Azzi ENT and Facial Reconstructive Surgery
Jupiter, Florida, United States
Prophase, LLC
Margate, Florida, United States
Millennium Medical Research
Miami, Florida, United States
Regis Clinical Research
Miami, Florida, United States
Gastroenterology of Greater Orlando
Orange City, Florida, United States
Millennium Physician Group
Port Charlotte, Florida, United States
Stuart Oncology Associates
Stuart, Florida, United States
Avita Clinical Research
Tampa, Florida, United States
Pulmonary & Sleep Specialists of Northeast Georgia, P.C
Winder, Georgia, United States
Christie Clinic
Champaign, Illinois, United States
Hope and Healing Cancer Services
Hinsdale, Illinois, United States
Iowa Clinic
West Des Moines, Iowa, United States
Hutchinson Clinic
Hutchinson, Kansas, United States
Northlake Gastroenterology Associates
Hammond, Louisiana, United States
Velocity Clinical Research
Annapolis, Maryland, United States
Capital Digestive Care
Chevy Chase, Maryland, United States
Huron Gastroenterology
Ypsilanti, Michigan, United States
Oncology Hematology Specialists
Mountain Lakes, New Jersey, United States
Southwest Gastroenterology
Albuquerque, New Mexico, United States
Westchester Putnam Gastro
Carmel, New York, United States
Associated Gastroenterologists of Central New York
Fayetteville, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Wilmington Health, PLLC
Wilmington, North Carolina, United States
Hightower Clinical
Oklahoma City, Oklahoma, United States
Susquehanna Research Group
Harrisburg, Pennsylvania, United States
Respiratory Specialists
Wyomissing, Pennsylvania, United States
GIA Clinical Trials, LLC
Knoxville, Tennessee, United States
Premier Family Physicians
Austin, Texas, United States
Activian Clinical Research (Scarsdale)
Houston, Texas, United States
Huntsville Research Institute, LLC
Huntsville, Texas, United States
Activian Clinical Research
Kingwood, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Other Identifiers
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HH-PRT-0005
Identifier Type: -
Identifier Source: org_study_id
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