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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)

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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.

Observationnelle1 650 participants recherchés39 sites1 pays

Catégories

Oncologie100%

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

  • Registered before enrolment beganFirst posted 2025-07-01; recorded start 2025-07-11
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Whether participants are randomly assigned is not stated in the registry recordNo allocation method is recorded
  • A comparison group is not stated in the registry recordThe record describes a single study arm
  • Whether the study is blinded is not stated in the registry recordNo masking information is recorded
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • 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.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 2 other studies in this databaseCounted from the lead sponsor named in the record (Harbinger Health)
  • 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.

Résumé

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.

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.

Affections

  • Cancer

Éligibilité

SexeTous
Âges45 Years – Aucun maximum
Volontaires sainsNon
Méthode d'échantillonnageNON_PROBABILITY_SAMPLE

Population de l'étude

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

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeObservationnelle
PhaseNon précisé dans la fiche du registre
RépartitionNon précisé dans la fiche du registre
Modèle d'interventionNon précisé dans la fiche du registre
Objectif principalNon précisé dans la fiche du registre
InsuNon précisé dans la fiche du registre
Recrutement1 650 participants recherchés

Promoteur et collaborateurs

  • Harbinger Health Promoteur

Groupes et 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

  • Autre 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.

Critères de jugement

  1. Critère de jugement 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.

    Délai 18 months

  2. Critère de jugement secondaire

    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.

    Délai 18 months

  3. Critère de jugement secondaire

    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.

    Délai 18 months

Dates

Date de début11 juillet 2025 (réelle)
Achèvement principal1 juillet 2026 (estimée)
Achèvement1 novembre 2026 (estimée)
Première publication1 juillet 2025 (réelle)
Dernière mise à jour11 mars 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foismars 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

35 sites sont en recrutement

United States

ÉtablissementVilleÉtat ou régionStatut
Southwest GastroenterologyAlbuquerqueNew MexicoRetiré
Velocity Clinical ResearchAnnapolisMarylandEn recrutement
Premier Family PhysiciansAustinTexasEn recrutement
Westchester Putnam GastroCarmelNew YorkEn recrutement
Rocky Mountain GastroenterologyCentennialColoradoEn recrutement
Christie ClinicChampaignIllinoisEn recrutement
Capital Digestive CareChevy ChaseMarylandRetiré
Zoyla Almeida, MD PACoconut CreekFloridaEn recrutement
Southern California Research CenterCoronadoCaliforniaEn recrutement
Cancer Center of Middle GeorgiaDublinGeorgiaEn recrutement
Associated Gastroenterologists of Central New YorkFayettevilleNew YorkEn recrutement
Northlake Gastroenterology AssociatesHammondLouisianaEn recrutement
Texas DigestiveHarlingenTexasEn recrutement
Susquehanna Research GroupHarrisburgPennsylvaniaEn recrutement
Hope and Healing Cancer ServicesHinsdaleIllinoisEn recrutement
Activian Clinical Research (Scarsdale)HoustonTexasEn recrutement
Huntsville Research Institute, LLCHuntsvilleTexasEn recrutement
Hutchinson ClinicHutchinsonKansasEn recrutement
Azzi ENT and Facial Reconstructive SurgeryJupiterFloridaEn recrutement
Activian Clinical ResearchKingwoodTexasEn recrutement
GIA Clinical Trials, LLCKnoxvilleTennesseeEn recrutement
Prophase, LLCMargateFloridaEn recrutement
Millennium Medical ResearchMiamiFloridaEn recrutement
Regis Clinical ResearchMiamiFloridaEn recrutement
Oncology Hematology SpecialistsMountain LakesNew JerseyEn recrutement
Memorial Sloan Kettering Cancer CenterNew YorkNew YorkEn recrutement
Hightower ClinicalOklahoma CityOklahomaEn recrutement
Gastroenterology of Greater OrlandoOrange CityFloridaEn recrutement
Millennium Physician GroupPort CharlotteFloridaRetiré
Palomar HealthPowayCaliforniaEn recrutement
South Coast Gynecologic OncologySan DiegoCaliforniaEn recrutement
Stuart Oncology AssociatesStuartFloridaEn recrutement
Avita Clinical ResearchTampaFloridaEn recrutement
Iowa ClinicWest Des MoinesIowaEn recrutement
Wilmington Health, PLLCWilmingtonNorth CarolinaEn recrutement
Pulmonary & Sleep Specialists of Northeast Georgia, P.CWinderGeorgiaEn recrutement
Respiratory SpecialistsWyomissingPennsylvaniaEn recrutement
Cancer Care Associates of YorkYorkPennsylvaniaEn recrutement
Huron GastroenterologyYpsilantiMichiganRetiré

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

Aucun changement n'a été enregistré depuis que nous avons intégré cette fiche pour la première fois.

Un changement est enregistré chaque fois que le promoteur met à jour la fiche du registre. Le statut, les dates, le recrutement et les sites apparaissent ici au fur et à mesure de leur évolution.

Registre: ClinicalTrials.gov · NCT########

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