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Study identifier: NCT07046260 Synced from ClinicalTrials.gov · August 09, 2026
● Study status: RecruitingPROCARES

Prospective Study to Assess a Diagnostic Aid for Cancer

Condition: Cancer  ·  Sponsor: Harbinger Health

PhaseN/A
Planned participants1650
Who can joinAll sexes, 45 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
Where39 locations

Interested? Contact the study team ↓

For sponsors, CROs & site teams
Professional view of this study — listed sites, countries and recruiting context from the public registry. Everything below is written for patients and caregivers.See where this study is running →

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Sara Bardwell  ·  (617) 446-9266  ·  sbardwell@harbinger-health.com

Nate Ruffle-Deignan  ·  nrdeignan@harbinger-health.com

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

Inclusion Criteria: 1. Subjects aged ≥45 years at the time of informed consent 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 90 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: 1. History of any prior invasive or hematological malignancy (Individuals with completely resected ductal carcinoma in-situ or completely resected non-melanoma skin cancer are permitted) 2. Subject is suffering from any febrile illness defined as a temperature \>101.5°F within 48 hours prior to blood draw 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

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (39)

Southern California Research CenterCoronado, California, United StatesRecruiting
Palomar HealthPoway, California, United StatesRecruiting
South Coast Gynecologic OncologySan Diego, California, United StatesRecruiting
Rocky Mountain GastroenterologyCentennial, Colorado, United StatesRecruiting
Zoyla Almeida, MD PACoconut Creek, Florida, United StatesRecruiting
Azzi ENT and Facial Reconstructive SurgeryJupiter, Florida, United StatesRecruiting
Prophase, LLCMargate, Florida, United StatesRecruiting
Millennium Medical ResearchMiami, Florida, United StatesRecruiting
Regis Clinical ResearchMiami, Florida, United StatesRecruiting
Gastroenterology of Greater OrlandoOrange City, Florida, United StatesRecruiting
Millennium Physician GroupPort Charlotte, Florida, United StatesWithdrawn
Stuart Oncology AssociatesStuart, Florida, United StatesRecruiting

+ 27 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

CoronadoPowaySan DiegoCentennial

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