Healthy Volunteer
Conditions
Interventions
None listed
Sponsors
Mahboobeh Safaeian
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Women and men 50-80 years at high-risk for development of lung cancer as below: a Current or previous cumulative cigarette smoking history of 20 pack years or more (packs per day multiplied by the number of years smoked). b 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 and within approximately 90 days from the date of enrollment blood draw. etc. - Women and men 45-85 years of age eligible for CRC screening (see Figure 1 in Introduction). - Willing and able to provide peripheral blood samples. - Willing and able to undergo optical colonoscopy and within approximately 90 days from the date of enrollment blood draw. etc.
Exclusion criteria
Exclusion criteria: - 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 - Currently taking any anti-neoplastic treatment or disease-modifying anti-rheumatic drugs (DMARDs). etc. - Subject has symptoms or signs leading to suspicion of CRC 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 9 years. - Subject has undergone, virtual (CT-based) colonoscopy, or flexible sigmoidoscopy within the previous 5 years. - Subject has a history of colorectal cancer or advanced adenoma or of large lesions - Subject has a history of any malignancy in the past 5 years - Currently taking any anti-neoplastic treatment or disease-modifying anti-rheumatic drugs (DMARDs). - Subject has had a fecal occult blood test or FIT within the previous 12 months. etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| other The determination of the primary clinical endpoint of confirmed lung cancer will be based on histology and pathology in the subject's medical records. The determination of the primary clinical endpoints of confirmed CRC and advanced adenoma will be based on the results from the colonoscopy and histology and pathology in the subject's medical records | — |
Countries
Japan, South Korea, Spain, UK, US
Contacts
Public ContactClinical trials information
Chugai Pharmaceutical Co., Ltd.
Outcome results
None listed