NCT06122077ClinicalTrials.gov

Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening

The PROACT LUNG Study: A Prospective, Observational,Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening (FRNM-007)

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En resumen

The PROACT LUNG study is a prospective multi-center observational study to validate a blood-based test for the early detection of lung cancer by collecting blood samples from high-risk participants who will undergo a routine, standard-of-care screening Low-Dose Computed Tomography (LDCT).

Observacional20.000 participantes buscados36 centros1 país

Categorías

Oncología56%Respiratorio32%Enfermedades infecciosas12%

Registrado en 1 registro

ClinicalTrials.govNCT06122077Abrir 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 2023-11-08; recorded start 2023-11-28
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: Whether there is a comparison group is not stated in the registry recordThe record does not describe the study arms
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 1 other study in this databaseCounted from the lead sponsor named in the record (Freenome Holdings Inc.)
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: 36 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEGA

A very large study: 20,000 participants (target), run at 36 sites.

How this score is built

Enrolment40/40
20,000 participants (target)
Site count18/25
36 sites
Country count0/15
Single country
Planned duration9/10
Planned over about 43 months
Sponsor scale1/10
Freenome Holdings Inc. has led 2 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

This is a prospective, multi-center, observational study to evaluate the performance of the Freenome Multiomics Blood Test in screening eligible participants for lung cancer. Enrollment will be open to all eligible participants for screening chest CT scan as part of the Standard of Care (SOC) for lung cancer. Subjects who meet the eligibility criteria for this study and provide informed consent will be enrolled and blood sample collection must be completed within 30 days of signing the informed consent. Optimally, the screening chest CT will be completed on the same day of the study blood collection, however up to 45 days will be allowed after study blood collection to obtain a screening chest CT. The study will also collect demographic data and relevant clinical data, such as medical history, lifestyle, occupational and environmental exposure(s), family history, and clinical laboratory data. All reports and clinical notes regarding the diagnostic tests and procedures related to lung cancer diagnosis or lung lesion assessment, such as histopathology and bronchoscopy reports, and diagnostic/follow-up images and imaging reports will be collected as part of follow up to the screening chest CT scan. All enrolled subjects will be followed prospectively from the date of the baseline screening chest CT until a minimum of 24 months, or until a premature study endpoint inclusive of withdrawal of consent or death.

Afecciones

Lung Cancer Diagnosis

Elegibilidad

Elegibilidad
Sexo	Todos
Edades	50 Years – Sin máximo
Voluntarios sanos	No
Método de muestreo	PROBABILITY_SAMPLE

Población del estudio

The study aims to enroll a representative sample of the population across the United States including adults aged 50 years and older who have at least a 20-pack-year smoking history and who have met the eligibility criteria defined in this protocol.

Elegibilidad tal como figura en el registro

Inclusion Criteria: 1. Age 50 years or older within 30 days of enrollment 2. Current or former smokers with a cumulative smoking history of ≥ 20 pack-year 3. Able to comprehend and willing to sign and date the informed consent and HIPAA authorization documents Exclusion Criteria: 1. Any active therapy for cancer, including but not limited to surgery, chemotherapy, biologic therapy, immunotherapy, and/or radiation therapy at the time of enrollment 2. History of any malignancy within prior 5 years of enrollment (except for non- melanoma skin cancer) 3. History of organ, tissue, and bone marrow transplantation 4. Screened for lung cancer or having chest CT scan 12 months before enrollment 5. Having signs and symptoms of lung cancer such as hemoptysis, superior vena cava syndrome, Cushing syndrome, and Pancoast syndrome 6. Received a blood transfusion in the 30 days preceding enrollment 7. Known to be pregnant 8. Participated or currently participating in another Freenome-sponsored clinical study 9. Participated or currently participating in a clinical research study in which an experimental medication has been administered during the 60 days preceding enrollment 10. Any condition that in the opinion of the Investigator should not be enrolled 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	20.000 participantes buscados

Patrocinador y colaboradores

Freenome Holdings Inc. Patrocinador

Intervenciones

Prueba diagnóstica blood draw
Subjects who provide informed consent and meet the eligibility criteria will have 50 ml of blood collected and sent to Freenome or Freenome's designee for processing, testing, and storage, and will then complete a standard-of-care screening LDCT.

Variables de resultado

Variable de resultado principal
Sensitivity and specificity in detecting lung cancer
Clinical performance of the Freenome Blood Test, including sensitivity and specificity, in detecting lung cancer in subjects with positive and negative lung cancer outcomes during a 12-month follow-up period
Plazo 12-Months
Variable de resultado secundaria
Sensitivity and specificity in detecting lung cancer
Clinical performance of the Freenome Blood Test, including sensitivity and specificity, in detecting lung cancer in subjects with positive and negative lung cancer outcomes during a 24-month follow-up period
Plazo 24-Months

Fechas

Fechas
Fecha de inicio	28 de noviembre de 2023 (real)
Finalización principal	15 de junio de 2026 (estimada)
Finalización	15 de junio de 2027 (estimada)
Primera publicación	8 de noviembre de 2023 (real)
Última actualización	5 de agosto de 2025
Resultados publicados	No indicado en el registro
Estado verificado por última vez	agosto de 2025

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

Ubicaciones

36 centros están en reclutamiento

United States

United States
Centro	Ciudad	Estado o región	Estado
Ascension St. Agnes Hospital	Baltimore	Maryland	En reclutamiento
Our Lady of Lourdes Hospital	Binghamton	New York	En reclutamiento
Medical University of South Carolina (MUSC)	Charleston	South Carolina	En reclutamiento
University of Chicago	Chicago	Illinois	En reclutamiento
Hillcrest Medical Research	DeLand	Florida	En reclutamiento
Walgreens	Deerfield	Illinois	En reclutamiento
Universal Axon Clinical Research	Doral	Florida	En reclutamiento
Clinical Research Associates of Central PA	DuBois	Pennsylvania	En reclutamiento
McLeod Health	Florence	South Carolina	En reclutamiento
SpeciCare, Inc	Gainesville	Georgia	En reclutamiento
Altru Health System	Grand Forks	North Dakota	En reclutamiento
Memorial Hospital at Gulfport	Gulfport	Mississippi	En reclutamiento
Horizon Clinical Research Group	Houston	Texas	En reclutamiento
Cape Cod Hospital	Hyannis	Massachusetts	En reclutamiento
The Jackson Clinic, PA	Jackson	Tennessee	En reclutamiento
I.H.S Health, LLC	Kissimmee	Florida	En reclutamiento
US Digestive Health at Lancaster	Lancaster	Pennsylvania	En reclutamiento
Aton Health	Leawood	Kansas	En reclutamiento
Science 37	Los Angeles	California	En reclutamiento
Ascension Columbia St. Mary's Wisconsin	Milwaukee	Wisconsin	En reclutamiento
Inspira Medical Center	Mullica Hill	New Jersey	En reclutamiento
Hightower Clinical	Oklahoma City	Oklahoma	En reclutamiento
Temple University	Philadelphia	Pennsylvania	En reclutamiento
Circle Clinical Research	Pierre	South Dakota	En reclutamiento
United Medical Research	Port Orange	Florida	En reclutamiento
Oregon Health & Science University	Portland	Oregon	En reclutamiento
Wakemed	Raleigh	North Carolina	En reclutamiento
Renown Regional Medical Center	Reno	Nevada	En reclutamiento
Guthrie Medical Group	Sayre	Pennsylvania	En reclutamiento
Springfield Clinic, LLP	Springfield	Illinois	En reclutamiento
Stamford Hospital	Stamford	Connecticut	En reclutamiento
Charter Research	The Villages	Florida	En reclutamiento
CHRISTUS Trinity Mother Frances Health System	Tyler	Texas	En reclutamiento
Ascension Via Christi Wichita	Wichita	Kansas	En reclutamiento
Charter Research	Winter Park	Florida	En reclutamiento
US Digestive Health at Wyomissing	Wyomissing	Pennsylvania	En reclutamiento

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/NCT06122077