Digestive System Diseases

All Conditions

Neoplasms

Symptoms and General Pathology

Colonic Diseases

Colonic Neoplasms

Adenoma

Colonic Polyps

Polyps

Rectal Diseases

Colorectal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Intestinal Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Pathological Conditions, Anatomical

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Participants who provide informed consent, meet the eligibility criteria and provide a blood sample for this study will be enrolled. Participants will undergo blood collection and will then complete a standard-of-care screening colonoscopy.

Freenome test

Aasma Shaukat, MD MPH

Theodore R Levin, MD

Lance Baldo, MD

The PREEMPT CRC study is a prospective multi-center observational study to validate a blood-based test for the early detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy.

Freenome is using a type of artificial intelligence, called machine learning, to identify patterns of cell-free biomarkers in blood to detect cancer early. The purpose of this prospective multi-center observational study is to validate a blood-based test for the detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy.

Blood specimens will be de-identified and used to validate the performance characteristics of the Freenome test.

Prevention of Colorectal Cancer Through Multiomics Blood Testing

Freenome Holdings Inc.

Respiratory Tract (Lung and Bronchial) Diseases

Diseases and Abnormalities at or Before Birth

Infections

Rare Diseases

Syndrome

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Lung Neoplasms

Lung Diseases

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Pulmonary Emphysema

Emphysema

Acute Lung Injury

Bronchitis

Bronchitis, Chronic

Respiratory Tract Neoplasms

Thoracic Neoplasms

Respiratory Tract Diseases

Chronic Graft Versus Host Disease

Respiratory Distress Syndrome, Infant

Acute Respiratory Distress Syndrome

Acute Graft Versus Host Disease

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.

blood draw

April Allison, BS

Harris Naemi, BS / Joye Choy, BS

Study Coordinator

Chuanbo Xu, PhD

Nasibeh Vatankhah, MD

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).

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.

Blood specimens will be de-identified and used to validate the performance characteristics of the Freenome Multiomics Blood Test

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)

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

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

Rectal Neoplasms

Intestinal Polyps

Blood and stool specimen collection.

Study samples must be collected prior to any treatment.

Blood and stool specimen collection.

Samples must be collected prior to performing bowel preparation for the colonoscopy.

Girish Putcha, M.D., Ph.D

Freenome is using a type of artificial intelligence, called machine learning, to identify patterns of cell-free biomarkers in blood to detect cancer early. The purpose of this study is to develop and validate a blood-based assay to detect colorectal cancer by collecting blood and stool samples from healthy patients undergoing routine screening colonoscopy and from patients recently diagnosed with colorectal cancer or advanced adenomas.

Early detection of cancer combined with effective treatment improves survival and quality of life. Freenome is using a type of artificial intelligence, called machine learning, to identify patterns of cell-free biomarkers in the blood to detect cancer early. The purpose of this study is to develop and validate a blood-based assay for the early detection of colorectal cancer. The study will collect blood and stool samples from healthy patients undergoing routine screening colonoscopy and from patients recently diagnosed with colorectal cancer or advanced adenomas. A blood-based test for colorectal cancer and pre-cancerous lesions could offer an accurate, convenient, and patient-friendly screening option for current and future generations, and, in doing so, could save and improve lives by increasing adherence and early detection.

Freenome is looking for three types of patients in this study:

Cohort A:

People ages 50-84 who have been recently diagnosed with (or strong clinical suspicion for) colorectal cancer or advanced adenoma. Blood samples must be collected before any cancer treatment has been initiated.

Cohort B:

People ages 50-84 undergoing routine screening colonoscopies for colorectal cancer as part of their regular medical check-ups. Blood samples must be collected before bowel preparation for the colonoscopy.

Cohort C:

People 18 years or older who have been recently diagnosed with (or strong clinical suspicion for) colorectal cancer or advanced adenoma. Blood samples must be collected before any cancer treatment has been initiated.

AI-EMERGE: Development and Validation of a Multi-analyte, Blood-based Colorectal Cancer Screening Test

Specimen Collection Study for Cancer

Clinically annotated plasma samples from participants will undergo multi-omic analyses to characterize cell-free biomarkers.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prevention of Colorectal Cancer Through Multiomics Blood Testing	NCT04369053	Colon Cancer Rectal Cancer Colon Neoplasm Colon Diseases Colon Lesion Colon Polyp Colorectal Canc... Polyp Adenoma Rectal Diseases Gastrointestina...	Freenome test	45 Years - 85 Years	Freenome Holdings Inc.
Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening	NCT06122077	Lung Cancer Dia...	blood draw	50 Years -	Freenome Holdings Inc.
AI-EMERGE: Development and Validation of a Multi-analyte, Blood-based Colorectal Cancer Screening Test	NCT03688906	Colo-rectal Can... Cancer Colon Cancer, Rectum Neoplasms,Color... Polyps Polyp of Colon Adenoma Adenoma Colon		18 Years -	Freenome Holdings Inc.
AI-EMERGE: Development and Validation of a Multi-analyte, Blood-based Colorectal Cancer Screening Test	NCT03688906	Colo-rectal Can... Cancer Colon Cancer, Rectum Neoplasms,Color... Polyps Polyp of Colon Adenoma Adenoma Colon		18 Years -	Freenome Holdings Inc.

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