Clinical Trials

Inclusion Criteria - Lung Cancer Cohort Population:

• Women and men 50–80 years at high-risk for development of lung cancer and eligible for LDCT-based lung cancer screening as below:
  • Current or previous cumulative cigarette smoking history of > 20 pack years (packs per day multiplied by the number of years smoked);
  • Former smokers must have quit smoking within the previous 15 years.
• Willing and able to provide peripheral blood samples.
• Willing and able to undergo LDCT screening within approximately 90 days from the date of enrollment blood draw.
• Willing and able to provide written informed consent.
• Willing and able to participate in 1-3 years of follow-up. 

Inclusion Criteria - Colorectal Cancer Cohort Population:

• Women and men 45–85 years of age eligible for CRC screening.
• Willing and able to provide peripheral blood samples.
• Willing and able to undergo optical colonoscopy within approximately 90 days from the date of enrollment blood draw. Blood draw to occur 2 days before colonoscopy (i.e., bowel prep before colonoscopy).
• Willing and able to provide written informed consent.
• Willing and able to participate in 1-3 years of Follow-up.

Exclusion Criteria - Lung Cancer Cohort Population:

• Subject has any condition which, in the opinion of the investigator, would preclude participation in the study.
• Preexisting or prior history of lung cancer.
• Subject has symptoms or signs leading to suspicion of lung cancer such as weight loss, cough, and hemoptysis and related symptoms, which in the opinion of the investigator, would preclude them from participation in the study.
• History of any malignancy in the past 5 years (subjects who have undergone surgical removal of skin squamous or basal cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study).
• The subject is not eligible, in the opinion of the investigator, to undergo LDCT screening due to a health problem that limits life expectancy or the ability to have lung surgery.
• Currently taking any anti-neoplastic treatment or disease-modifying anti-rheumatic drugs (DMARDs).
• Currently receiving treatment for pneumonia, or had a confirmed pneumonia infection in the past 12 weeks.
• Any major physical trauma (e.g., disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent for the study.
• Subjects undergoing diagnostic low-dose CT scan for investigation of symptoms.
• Participation in any “interventional” clinical study within the previous 30 days in which an experimental treatment is administered or might be administered through a randomized assignment of the subject to one or more study groups.
• Prior removal of any portion of the lung, excluding percutaneous lung biopsy.
• Requirement for home oxygen supplementation for respiratory conditions.

Exclusion Criteria - Colorectal Cancer Cohort Population:

• Subject has any condition which, in the opinion of the investigator should preclude participation in the study.
• Subject has symptoms or signs leading to suspicion of colorectal cancer such as weight loss, abdominal pain, or other gastrointestinal (GI) related symptoms, which in the opinion of the investigator, would preclude them from participation in the study.
• Subject has undergone colonoscopy within the previous nine (9) years.
• Subject has undergone, virtual (CT-based) colonoscopy, or flexible sigmoidoscopy within the previous five (5) years.
• Subject has a history of colorectal cancer or advanced adenoma or lesions of large lesions; i.e., ≥ 20 mm.
• Subject has a history of any malignancy in the past 5 years (subjects who have undergone surgical removal of skin squamous or basal cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study).
• Currently taking any anti-neoplastic treatment or disease-modifying anti-rheumatic drugs (DMARDs).
• Subject has had a positive fecal occult blood test or fecal immunochemical test (FIT) within the previous 12 months.
• Subject has had a positive Cologuard test within the previous 3 years.
• Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease.
• Subject has had overt rectal bleeding; e.g., hematochezia or melena, within the previous 30 days.
  • Note: Blood on toilet paper, after wiping, does not constitute rectal bleeding.
• Subject has a diagnosis or personal history of any of the following high-risk conditions for colorectal cancer:
  • Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn’s disease;
  • > 2 first-degree relatives who have been diagnosed with colon cancer (Note: firstdegree relatives include parents, siblings and offspring.);
  • One first-degree relative with CRC diagnosed before the age of 60;
  • Familial adenomatous polyposis (also referred to as “FAP”, including attenuated FAP);
  • Hereditary non-polyposis colorectal cancer syndrome (also referred to as “HNPCC” or “Lynch Syndrome”);
  • Other hereditary cancer syndromes including but are not limited to Peutz–Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner’s Syndrome, Turcot’s (or Crail’s) Syndrome, Cowden’s Syndrome, Juvenile Polyposis, CronkhiteCanada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis.
• Participation in any “interventional” clinical study within the previous 30 days in which an experimental treatment is administered or might be administered through a randomized assignment of the subject to one or more study groups.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/2/23. Questions regarding updates should be directed to the study team contact.