💬In plain words
What the trial is, and whether it could suit you
This study is being done to establish "normal' values for a new blood test and urine test approach to cancer screening. Patients undergo blood and urine sample collection on study. Patients' medical records are reviewed.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* 10,000 patients without a known internal (non-cutaneous) cancer or a history of an internal cancer
* To balance age, rough recruitment goals will be set for the following subsets: 18-39 years, 40-49 years , 50-59 years , 60-69 years , 70-79 years , and \>= 80 years
* To balance sex, roughly half of the participants recruited within each age subset will be women
* Roughly half of all participants will have had a colonoscopy or colon x-ray within the past 5 years, or Cologuard® test in the last 3 years which were negative for cancer and precancerous lesions
* Roughly half of all participants will have had a chest x-ray within the past 5 years which was negative for cancer
* Roughly half of women participants will have had a mammography in the past 5 years which was negative for cancer
* An attempt will be made to recruit minimums (parentheses) of the following subsets: men with normal Prostate-specific antigen (PSA) level (200); diabetes mellitus (200); connective tissue diseases like rheumatoid arthritis, systemic lupus erythematosus, and scleroderma (100); chronic obstructive lung disease (100); inflammatory bowel disease or cirrhosis (100), and pancreatitis (100)
* To assess the effects of other common covariates, specific recruitment targets will not be set. Rather, data obtained on all participants will include BMI, smoking (past/present), alcohol consumption, pregnant status (women), and selected medications (steroidal and non-steroidal anti-inflammatory drugs, statins, anti-hypertensives, and anti-depressants)
Exclusion Criteria:
* Patients has a past or current diagnosis of invasive cancer (this does not include basal cell or squamous cell skin cancers)
* Patient has had a solid organ transplant
* Inability to give informed consent
URINE EXCLUSIONS
* Patient has transurethral instrumentation (cystoscopy, placement of urinary catheter) within the 7 days prior to sample collection
* Patient has chronic indwelling urinary catheter
* Patient has had a urinary tract infection within the 14 days prior to sample collection
SALIVA EXCLUSIONS
* Patient has known clinically significant xerostomia
* Patient has known recent (within 30 days prior to collection) active upper respiratory tract infection or anogenital infection