Panomics Relationships in the Epidemiology of Cancer Through In Silico Expression (PRECISE)

This study will enroll all subjects who are eligible and willing to participate with a goal
of enrolling at least 10,000 in several categories: (i) Patients with Family History of
Cancer, (ii) Patients with Clinical and Environmental Risk Factors for Cancer, and (iii)
Patients with a Suspected or Confirmed Diagnosis of Cancer.

Inclusion Criteria:

- Patients with Family History of Cancer

1. Ages 18 or older

2. Either of the following:

1. Patients with two or more first, second or third degree blood relatives on
the same side of the family diagnosed with cancer

2. Patients with one or more first, second or third degree blood relative with
male breast cancer

3. Patients with a first, second, or third degree blood relative with a known
BRCA1 or BRCA2 mutation

4. Patients with a first, second, or third degree blood relative who has had
colorectal or endometrial cancer diagnosed before age 50 years

5. Patients with first degree relatives with a known deleterious APC, MEN1,
MUTYH, PTEN, RET, STK11, TP53, or VHL gene mutation

6. Patients of Ashkenazi Jewish descent with one or more first degree relatives
or two or more second degree relatives with breast, ovarian or colorectal
cancer

3. The patient has signed the appropriate Institutional Review Board approved
Informed Consent Form

Patients with Clinical & Environmental Risk Factors for Cancer

1. Either of the following:

1. Women 21 or older

2. Men 50-75

3. Men 75-85, with a history of smoking

2. At least one guideline recommended cancer screening test documented in the
medical record, if indicated for age and gender (eg, pap smear, mammography, low
dose chest CT and/or colonoscopy)

3. The patient has signed the appropriate Institutional Review Board approved
Informed Consent Form Cancer Patients

1. Ages 18 or older

2. Either of the following:

1. New diagnosis of histologically confirmed cancer (any stage I-IV, as well as
carcinoma in situ (CIS)), across multiple solid tumor types with no prior
systemic cancer therapy and scheduled for surgical resection or non-surgical
management

2. Or, subjects with a high suspicion for cancer diagnosis by clinical and
radiological assessment, but without preceding histologic diagnosis, are
eligible, if they have not received prior systemic cancer therapy and are
scheduled for surgery

3. Has or will have a medically obtained pathological tumor specimen from core
needle or surgical biopsy and/or surgical resection within 4 weeks (28 days) of
study blood draw and pre-treatment

4. The patient has signed the appropriate Institutional Review Board approved
Informed Consent Form

Exclusion Criteria:

- 1. Blood or blood product transfusion in the preceding 2 months 2. Cognitive
impairment as determined by clinical history 3. Pregnant women (by self-report of
pregnancy status) 4. Inability to speak English 5. Previous diagnosis of cancer
except: non-melanomatous skin cancer 6. Poor health status or unfit to tolerate blood
draw