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)

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En resumen

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.

Observacional1650 participantes buscados39 centros1 país

Categorías

Oncología100%

Registrado en 1 registro

ClinicalTrials.govNCT07046260Abrir este registro en ClinicalTrials.govSincronizado hace 2 meses

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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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.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

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.

Methodological rigourEXPLORATORY

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

ScaleLARGE

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

Investigator standingUNKNOWN

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.

Resumen

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.

Afecciones

Cancer

Elegibilidad

Elegibilidad
Sexo	Todos
Edades	45 Years – Sin máximo
Voluntarios sanos	No
Método de muestreo	NON_PROBABILITY_SAMPLE

Población del estudio

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

Elegibilidad tal como figura en el registro

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

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudio	Observacional
Fase	No indicado en el registro
Asignación	No indicado en el registro
Modelo de intervención	No indicado en el registro
Propósito principal	No indicado en el registro
Enmascaramiento	No indicado en el registro
Inscripción	1650 participantes buscados

Patrocinador y colaboradores

Harbinger Health Patrocinador

Grupos e intervenciones

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.

Intervenciones

Otro 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.

Variables de resultado

Variable de resultado principal
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.
Plazo 18 months
Variable de resultado secundaria
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.
Plazo 18 months
Variable de resultado secundaria
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.
Plazo 18 months

Fechas

Fechas
Fecha de inicio	11 de julio de 2025 (real)
Finalización principal	1 de julio de 2026 (estimada)
Finalización	1 de noviembre de 2026 (estimada)
Primera publicación	1 de julio de 2025 (real)
Última actualización	11 de marzo de 2026
Resultados publicados	No indicado en el registro
Estado verificado por última vez	marzo de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

35 centros están en reclutamiento

United States

United States
Centro	Ciudad	Estado o región	Estado
Southwest Gastroenterology	Albuquerque	New Mexico	Retirado
Velocity Clinical Research	Annapolis	Maryland	En reclutamiento
Premier Family Physicians	Austin	Texas	En reclutamiento
Westchester Putnam Gastro	Carmel	New York	En reclutamiento
Rocky Mountain Gastroenterology	Centennial	Colorado	En reclutamiento
Christie Clinic	Champaign	Illinois	En reclutamiento
Capital Digestive Care	Chevy Chase	Maryland	Retirado
Zoyla Almeida, MD PA	Coconut Creek	Florida	En reclutamiento
Southern California Research Center	Coronado	California	En reclutamiento
Cancer Center of Middle Georgia	Dublin	Georgia	En reclutamiento
Associated Gastroenterologists of Central New York	Fayetteville	New York	En reclutamiento
Northlake Gastroenterology Associates	Hammond	Louisiana	En reclutamiento
Texas Digestive	Harlingen	Texas	En reclutamiento
Susquehanna Research Group	Harrisburg	Pennsylvania	En reclutamiento
Hope and Healing Cancer Services	Hinsdale	Illinois	En reclutamiento
Activian Clinical Research (Scarsdale)	Houston	Texas	En reclutamiento
Huntsville Research Institute, LLC	Huntsville	Texas	En reclutamiento
Hutchinson Clinic	Hutchinson	Kansas	En reclutamiento
Azzi ENT and Facial Reconstructive Surgery	Jupiter	Florida	En reclutamiento
Activian Clinical Research	Kingwood	Texas	En reclutamiento
GIA Clinical Trials, LLC	Knoxville	Tennessee	En reclutamiento
Prophase, LLC	Margate	Florida	En reclutamiento
Millennium Medical Research	Miami	Florida	En reclutamiento
Regis Clinical Research	Miami	Florida	En reclutamiento
Oncology Hematology Specialists	Mountain Lakes	New Jersey	En reclutamiento
Memorial Sloan Kettering Cancer Center	New York	New York	En reclutamiento
Hightower Clinical	Oklahoma City	Oklahoma	En reclutamiento
Gastroenterology of Greater Orlando	Orange City	Florida	En reclutamiento
Millennium Physician Group	Port Charlotte	Florida	Retirado
Palomar Health	Poway	California	En reclutamiento
South Coast Gynecologic Oncology	San Diego	California	En reclutamiento
Stuart Oncology Associates	Stuart	Florida	En reclutamiento
Avita Clinical Research	Tampa	Florida	En reclutamiento
Iowa Clinic	West Des Moines	Iowa	En reclutamiento
Wilmington Health, PLLC	Wilmington	North Carolina	En reclutamiento
Pulmonary & Sleep Specialists of Northeast Georgia, P.C	Winder	Georgia	En reclutamiento
Respiratory Specialists	Wyomissing	Pennsylvania	En reclutamiento
Cancer Care Associates of York	York	Pennsylvania	En reclutamiento
Huron Gastroenterology	Ypsilanti	Michigan	Retirado

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

No se han registrado cambios desde que incorporamos este registro por primera vez.

Se registra un cambio cada vez que el patrocinador actualiza el registro. El estado, las fechas, la inscripción y los centros aparecen aquí a medida que cambian.

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07046260