NCT07046260ClinicalTrials.gov
Prospective Study to Assess a Diagnostic Aid for Cancer
Prospective Cohort Study With Case Enrichment to Assess a Diagnostic Aid for Cancer in Symptomatic Subjects (PROCARES)
In brief
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.
Observational1,650 participants sought39 sites1 country
Categories
Registered in 1 registry
- ClinicalTrials.govNCT07046260Open this record at ClinicalTrials.govSynced 2 months ago
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Trial information is shown as published by the registry, in its original language.
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How this study is set up
The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.
- Present: Registered before enrolment beganFirst posted 2025-07-01; recorded start 2025-07-11
- Present: Has a defined primary outcomeA primary outcome measure is listed in the record
- Present: The primary outcome states a time frameThe primary outcome measure records a time frame
- Not stated: Whether participants are randomly assigned is not stated in the registry recordNo allocation method is recorded
- Not stated: A comparison group is not stated in the registry recordThe record describes a single study arm
- Not stated: Whether the study is blinded is not stated in the registry recordNo masking information is recorded
- Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
- Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
- Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
- Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
- Present: Sponsor has 2 other studies in this databaseCounted from the lead sponsor named in the record (Harbinger Health)
- Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
- The record lists 1 condition.
- Lead sponsor type recorded as: industry.
Trial stature
Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.
An exploratory-stage design for a study of this type, judged from its ClinicalTrials.gov record.
How this score is built
- Randomised allocation0/20
Allocation not stated in the record
- Blinding0/20
Masking not stated in the record
- Control arm0/15
No comparator arm stated in the record
- Primary-outcome specificity10/10
Named primary outcome with a defined time frame
- Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
- Multi-centre8/8
Multi-centre: 39 sites
- Data monitoring committee0/7
No data monitoring committee stated
- Prospective registration5/5
Registered before the study start date
- Protocol / SAP posted0/5
No protocol or SAP posted to the registry
A large study: 1,650 participants (target), run at 39 sites.
How this score is built
- Enrolment32/40
1,650 participants (target)
- Site count19/25
39 sites
- Country count0/15
Single country
- Planned duration6/10
Planned over about 16 months
- Sponsor scale1/10
Harbinger Health has led 3 trials in our corpus
We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.
How this score is built
- Investigator standing0/100
No investigator recorded in the registry for this trial
These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.
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.
Conditions
- Cancer
Eligibility
| Sex | All |
|---|---|
| Ages | 45 Years – No maximum |
| Healthy volunteers | No |
| Sampling method | NON_PROBABILITY_SAMPLE |
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
Eligibility as written in the registry
Eligibility in plain statements
This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.
Study design
| Study type | Observational |
|---|---|
| Phase | Not stated in the registry record |
| Allocation | Not stated in the registry record |
| Intervention model | Not stated in the registry record |
| Primary purpose | Not stated in the registry record |
| Masking | Not stated in the registry record |
| Enrolment | 1,650 participants sought |
Sponsor and collaborators
- Harbinger Health Sponsor
Arms and interventions
- 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.
Interventions
- Other Blood 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 outcome
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 outcome
Quantify test readout distribution, likelihood ratio, and marginal classification 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. * Establish for each Harbinger test the likelihood ratio for each readout category, overall, by cancer stage and further by cancer type. * Establish for each Harbinger test the classification category frequency distribution.
Time frame 18 months
Secondary outcome
Establish cancer incidence in this intended use population
-Establish the cancer incidence, overall and by early-stage (I and II) and late-stage (III and IV) and further by cancer type.
Time frame 18 months
Dates
| Start date | July 11, 2025 (actual) |
|---|---|
| Primary completion | July 1, 2026 (estimated) |
| Completion | November 1, 2026 (estimated) |
| First posted | July 1, 2025 (actual) |
| Last updated | March 11, 2026 |
| Results posted | Not stated in the registry record |
| Status last verified | March 2026 |
Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.
Locations
35 sites are recruiting
United States
| Facility | City | State or region | Status |
|---|---|---|---|
| Southwest Gastroenterology | Albuquerque | New Mexico | Withdrawn |
| Velocity Clinical Research | Annapolis | Maryland | Recruiting |
| Premier Family Physicians | Austin | Texas | Recruiting |
| Westchester Putnam Gastro | Carmel | New York | Recruiting |
| Rocky Mountain Gastroenterology | Centennial | Colorado | Recruiting |
| Christie Clinic | Champaign | Illinois | Recruiting |
| Capital Digestive Care | Chevy Chase | Maryland | Withdrawn |
| Zoyla Almeida, MD PA | Coconut Creek | Florida | Recruiting |
| Southern California Research Center | Coronado | California | Recruiting |
| Cancer Center of Middle Georgia | Dublin | Georgia | Recruiting |
| Associated Gastroenterologists of Central New York | Fayetteville | New York | Recruiting |
| Northlake Gastroenterology Associates | Hammond | Louisiana | Recruiting |
| Texas Digestive | Harlingen | Texas | Recruiting |
| Susquehanna Research Group | Harrisburg | Pennsylvania | Recruiting |
| Hope and Healing Cancer Services | Hinsdale | Illinois | Recruiting |
| Activian Clinical Research (Scarsdale) | Houston | Texas | Recruiting |
| Huntsville Research Institute, LLC | Huntsville | Texas | Recruiting |
| Hutchinson Clinic | Hutchinson | Kansas | Recruiting |
| Azzi ENT and Facial Reconstructive Surgery | Jupiter | Florida | Recruiting |
| Activian Clinical Research | Kingwood | Texas | Recruiting |
| GIA Clinical Trials, LLC | Knoxville | Tennessee | Recruiting |
| Prophase, LLC | Margate | Florida | Recruiting |
| Millennium Medical Research | Miami | Florida | Recruiting |
| Regis Clinical Research | Miami | Florida | Recruiting |
| Oncology Hematology Specialists | Mountain Lakes | New Jersey | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| Hightower Clinical | Oklahoma City | Oklahoma | Recruiting |
| Gastroenterology of Greater Orlando | Orange City | Florida | Recruiting |
| Millennium Physician Group | Port Charlotte | Florida | Withdrawn |
| Palomar Health | Poway | California | Recruiting |
| South Coast Gynecologic Oncology | San Diego | California | Recruiting |
| Stuart Oncology Associates | Stuart | Florida | Recruiting |
| Avita Clinical Research | Tampa | Florida | Recruiting |
| Iowa Clinic | West Des Moines | Iowa | Recruiting |
| Wilmington Health, PLLC | Wilmington | North Carolina | Recruiting |
| Pulmonary & Sleep Specialists of Northeast Georgia, P.C | Winder | Georgia | Recruiting |
| Respiratory Specialists | Wyomissing | Pennsylvania | Recruiting |
| Cancer Care Associates of York | York | Pennsylvania | Recruiting |
| Huron Gastroenterology | Ypsilanti | Michigan | Withdrawn |
Study documents
No documents are linked in this registry record.
Changes over time
No changes have been recorded since we first ingested this record.
A change is recorded each time the sponsor updates the registry record. Status, dates, enrolment and sites appear here as they move.