Status:
WITHDRAWN
Panomics Relationships in the Epidemiology of Cancer Through In Silico Expression (PRECISE)
Lead Sponsor:
Greater Baltimore Medical Center
Conditions:
Cancer
Patients With Clinical and Environmental Risk Factors for Cancer
Eligibility:
All Genders
18+ years
Brief Summary
PRECISE is a study to discover new detection, prognosis and treatment biomarkers for cancer. This is a prospective, multi-center, observational study designed to collect de-identified biospecimens and...
Detailed Description
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) Patient...
Eligibility Criteria
Inclusion
- Patients with Family History of Cancer
- Ages 18 or older
- Either of the following:
- Patients with two or more first, second or third degree blood relatives on the same side of the family diagnosed with cancer
- Patients with one or more first, second or third degree blood relative with male breast cancer
- Patients with a first, second, or third degree blood relative with a known BRCA1 or BRCA2 mutation
- Patients with a first, second, or third degree blood relative who has had colorectal or endometrial cancer diagnosed before age 50 years
- Patients with first degree relatives with a known deleterious APC, MEN1, MUTYH, PTEN, RET, STK11, TP53, or VHL gene mutation
- 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
- The patient has signed the appropriate Institutional Review Board approved Informed Consent Form
- Patients with Clinical \& Environmental Risk Factors for Cancer
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- Either of the following:
- Women 21 or older
- Men 50-75
- Men 75-85, with a history of smoking
- 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)
- The patient has signed the appropriate Institutional Review Board approved Informed Consent Form Cancer Patients
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- Ages 18 or older
- Either of the following:
- 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
- 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
- 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
- The patient has signed the appropriate Institutional Review Board approved Informed Consent Form
Exclusion
- 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
Key Trial Info
Start Date :
November 29 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03304990
Start Date
November 29 2018
End Date
January 1 2019
Last Update
July 22 2020
Active Locations (1)
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1
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204