CancerPROCARESNCT07046260
Prospective Study to Assess a Diagnostic Aid for Cancer
An observational study of Cancer, run by Harbinger Health at 42 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Blood sample collection
- How many people
- 2,450 participants
- Where
- 42 sitesUnited States
- Study dates
- 11 Jul 2025to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll individuals 45 years of age or older who present with symptoms, signs, and/or have findings leading to a clinical suspicion or a diagnosis of one or more cancers originating from the following sites: * Biliary Tract * Colon * Esophagogastric Junction (EGJ) * Esophagus * Gallbladder * Head and Neck * Liver * Lung * Lymphatic System * Ovary * Pancreas * Rectum * Stomach
Who may be able to join
- Subjects aged ≥45 years at the time of informed consent
- 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
- Presentation with symptoms, signs, and/or findings that raise clinical suspicion of one or more of the protocol-specified sites AND
- 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
- 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.
Who cannot join
- 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)
- Subject is suffering from any febrile illness defined as a temperature >101.5°F within 48 hours prior to blood draw
- Subject is pregnant (Self-reported)
- 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)
- Inability or unwillingness to comply with study procedures or follow-up requirement
- Previous or current participation in any study sponsored by, or employment with, Harbinger Health
- Participation in a clinical research study sponsored by an external organization which may interfere with study procedures or outcomes
- Subject has any condition that in the opinion of the Investigator should preclude participation in the study
Trial locations and contacts
42 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nate Ruffle-Deignan contact
42 sites in 1 country
United States42 sites, 37 recruiting
- Withdrawn
Southwest Gastroenterology
Albuquerque, New Mexico, 87109
- Recruiting
Velocity Clinical Research
Annapolis, Maryland, 21401
443-659-8685, scook2@velocityclinical.com
- Recruiting
Premier Family Physicians
Austin, Texas, 78735
Christy Springs, 512-892-7076, csprings@innovoresearch.com
- Recruiting
Westchester Putnam Gastro
Carmel, New York, 10512
Sarah Delacruz, 845-278-5223, sdelacruz@putnamgi.com
- Recruiting
Rocky Mountain Gastroenterology
Centennial, Colorado, 80112
Ian Reagin, 303-228-8616, ireagin@jointopo.com
- Recruiting
Christie Clinic
Champaign, Illinois, 61820
Megan Rodgers, 217-366-8056, mrodgers@christieclinic.com
- Withdrawn
Capital Digestive Care
Chevy Chase, Maryland, 20815
- Recruiting
Zoyla Almeida, MD PA
Coconut Creek, Florida, 33073
Danielle Fritz, 954-420-9182, dfritz@femwell.com
- Recruiting
Southern California Research Center
Coronado, California, 92118
Kasey Seyer, (321) 321-4684, kasey@researchscrc.com
- Recruiting
Cancer Center of Middle Georgia
Dublin, Georgia, 31021
Audrey Bryan, 478-272-8266, research@ccmgeorgia.com
- Recruiting
Associated Gastroenterologists of Central New York
Fayetteville, New York, 13066
Tabatha Jackson, 315-329-7300, tjackson@assocgastro.com
- Recruiting
Northlake Gastroenterology Associates
Hammond, Louisiana, 70403
Tiffany Ross, 985-542-1334, Tiffany@northlakegastro.com
- Recruiting
Texas Digestive
Harlingen, Texas, 78550
Carlette Villarreal, 956-365-4400, cvillarreal@texasdigestive.com
- Recruiting
Susquehanna Research Group
Harrisburg, Pennsylvania, 17110
Jessica Balay, 717-914-7770, jbalay@gicare.com
- Recruiting
BioResearch Partner
Hialeah, Florida, 33013
Fizza Quraishi, 321-321-4684, Fizza@clinosis.com
- Recruiting
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521
Ava Baftirovska, 630-456-2907 ext. 107, abaftirovska@hopenheal.care
- Withdrawn
Activian Clinical Research (Scarsdale)
Houston, Texas, 77089
- Recruiting
Huntsville Research Institute, LLC
Huntsville, Texas, 77340
Nicole Sehgal, 936-439-4835, nicolesehgal@yahoo.com
- Recruiting
Hutchinson Clinic
Hutchinson, Kansas, 67502
Amy Martens, 620-694-2066, amartens@innovoresearch.com
- Recruiting
Azzi ENT and Facial Reconstructive Surgery
Jupiter, Florida, 33477
Natasha Rodriguez, 561-979-2001, nrodriguez@yanuvia.com
- Recruiting
Aton Health
Kansas City, Missouri, 64114
Danielle Ouimet, 778-549-8611, douimet@atonhealth.com
- Recruiting
Activian Clinical Research
Kingwood, Texas, 77339
Katie Thomas, 832-225-4800, kthomas@activian.com
- Recruiting
GIA Clinical Trials, LLC
Knoxville, Tennessee, 37909
Kaitlynn Smith, 865-588-5121, ksmith@gihealthcare.com
- Recruiting
Prophase, LLC
Margate, Florida, 33063
Damian Sosa, 954-532-0791, dsosa@prophase-research.com
- Recruiting
Millennium Medical Research
Miami, Florida, 33126
Rafael Gonzalez, 210-363-5481, rgonzalez@millenniummedresearch.com
- Recruiting
Regis Clinical Research
Miami, Florida, 33126
305-546-3952, reyes@regisclinical.com
- Recruiting
Oncology Hematology Specialists
Mountain Lakes, New Jersey, 07046
Erika Ramirez, 973-316-1701, eramirez@ohsnj.com
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Emily Carbone, 212-639-8157, carbonee@mskcc.org
- Recruiting
Hightower Clinical
Oklahoma City, Oklahoma, 73102
Jamie Massengill, 210-363-5481, feas@clinitiative.com
- Recruiting
Gastroenterology of Greater Orlando
Orange City, Florida, 32763
Douglas Winter, 386-668-2221 ext. 1049, dwinter@gastro-md.com
- Withdrawn
Millennium Physician Group
Port Charlotte, Florida, 33952
- Recruiting
Palomar Health
Poway, California, 92064
Gladiz Ponce, (858) 260-3286, gponce@jointopo.com
- Recruiting
South Coast Gynecologic Oncology
San Diego, California, 92108
Devon Fahlsing, 858-455-5524, devon@scgoi.com
- Recruiting
Springfield Clinic
Springfield, Illinois, 62702
Sara Ditchen, 309-310-8294, research@springfieldclinic.com
- Recruiting
Stuart Oncology Associates
Stuart, Florida, 34994
Katrina Petters, 772-276-7242, katrina@stuartoncology.com
- Recruiting
Avita Clinical Research
Tampa, Florida, 33613
Alain Morales, 813-603-1800, alain@avitaclinicalresearch.com
- Recruiting
Iowa Clinic
West Des Moines, Iowa, 50266
Chantal Pelzer, 336-972-2909, cpelzer@innovoresearch.com
- Recruiting
Wilmington Health, PLLC
Wilmington, North Carolina, 28401
Jarrod Vaughn, 910-362-4040, JaVaughn@wilmingtonhealth.com
- Recruiting
Pulmonary & Sleep Specialists of Northeast Georgia, P.C
Winder, Georgia, 30680
Daphne Delee, 770-586-0300, ddelee@pulmonarysleepmed.com
- Recruiting
Respiratory Specialists
Wyomissing, Pennsylvania, 19610
Lisa Hill, 610-685-5864, lhill@lungmd.net
- Recruiting
Cancer Care Associates of York
York, Pennsylvania, 17403
Jennifer Stough, 717-741-9229, jstough@cancercareyork.com
- Withdrawn
Huron Gastroenterology
Ypsilanti, Michigan, 48197
About this study
Official title: Prospective Cohort Study With Case Enrichment to Assess a Diagnostic Aid for Cancer in Symptomatic Subjects (PROCARES)
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Blood sample collection
- Keywords
- Cancer, Diagnostic, Oncology, Test, Observational
- Medical subject headings
- Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionOther
Also called Diagnostic Aid Test
The study will collect up to 40 mL of whole peripheral blood in Streck Cell-Free DNA BCT® tubes from each participant.
| Study group | Role | What they receive |
|---|---|---|
| Patients with clinical suspicion of cancer or patients recently diagnosed with Cancer | Individuals 45 years of age or older 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. Receives: Other: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of diagnostic aid test 1 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) test
Predictive value of the Harbinger multi-cancer (MC) test by each readout category.
Measured: 18 months
Performance of diagnostic aid test 2 among individuals presenting with symptoms, signs and/or clinical findings suggestive of one or more cancers originating from the protocol-specified sites: gastrointestinal-focused (GI) test
Predictive value of the Harbinger GI test by each readout category.
Measured: 18 months
Secondary outcomes (4)
Quantify test readout distribution of each Harbinger test
-Establish for each Harbinger test the classification distributions for non-cancer individuals, and for cancer cases overall and by early-stage (I and II) and late-stage (III and IV) and further by cancer type.
Measured: 18 months
Quantify the likelihood ratio of each Harbinger test
-Establish for each Harbinger test the likelihood ratio for each readout category, overall, by cancer stage and further by cancer type.
Measured: 18 months
Quantify the marginal classification distribution of each Harbinger test
To establish for each Harbinger test the classification category frequency distribution
Measured: 18 months
Establish cancer incidence in intended use population
To establish the cancer incidence, overall and by early-stage (I and II) and late-stage (III and IV) and further by cancer type
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start11 Jul 2025
- Primary completionNov 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbinger Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luke Pike, MD, DPhil, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046260
- Sponsor's protocol ID
- HH-PRT-0005
- Acronym
- PROCARES
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study With Case Enrichment to Assess a Diagnostic Aid for Cancer in Symptomatic Subjects (PROCARES)
- ClinicalTrials.gov ID
- NCT07046260
- Acronym / sponsor ID
- PROCARES / HH-PRT-0005
- Conditions
- Cancer
- Keywords
- Cancer, Diagnostic, Oncology, Test, Observational
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,450 participants (estimated)
- Lead sponsor
- Harbinger HealthIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with clinical suspicion of cancer or patients recently diagnosed with Cancer | – | Other: Blood sample collectionIndividuals 45 years of age or older 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll individuals 45 years of age or older who present with symptoms, signs, and/or have findings leading to a clinical suspicion or a diagnosis of one or more cancers originating from the following sites: * Biliary Tract * Colon * Esophagogastric Junction (EGJ) * Esophagus * Gallbladder * Head and Neck * Liver * Lung * Lymphatic System * Ovary * Pancreas * Rectum * Stomach
Key inclusion criteria (5 listed)
- Subjects aged ≥45 years at the time of informed consent
- 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
- Presentation with symptoms, signs, and/or findings that raise clinical suspicion of one or more of the protocol-specified sites AND
Key exclusion criteria (8 listed)
- 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)
- Subject is suffering from any febrile illness defined as a temperature >101.5°F within 48 hours prior to blood draw
- Subject is pregnant (Self-reported)
- 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)
- Inability or unwillingness to comply with study procedures or follow-up requirement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collectionAlso: Diagnostic Aid TestThe study will collect up to 40 mL of whole peripheral blood in Streck Cell-Free DNA BCT® tubes from each participant. | Other | Patients with clinical suspicion of cancer or patients recently diagnosed with Cancer |
Primary outcome
Performance of diagnostic aid test 1 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) test
Time frame: 18 months
Predictive value of the Harbinger multi-cancer (MC) test by each readout category.
Performance of diagnostic aid test 2 among individuals presenting with symptoms, signs and/or clinical findings suggestive of one or more cancers originating from the protocol-specified sites: gastrointestinal-focused (GI) test
Time frame: 18 months
Predictive value of the Harbinger GI test by each readout category.
4 secondary outcomes
Quantify test readout distribution of each Harbinger test
Time frame: 18 months
Quantify the likelihood ratio of each Harbinger test
Time frame: 18 months
Quantify the marginal classification distribution of each Harbinger test
Time frame: 18 months
Establish cancer incidence in intended use population
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nate Ruffle-Deignan contact
Luke Pike, MD, DPhil principal investigator
Memorial Sloan Kettering Cancer Center
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Harbinger Health at 42 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Bardwell ((617) 446-9266, sbardwell@harbinger-health.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of diagnostic aid test 1 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) test (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.