Clinical trial NCT03304990: Panomics Relationships in the Epidemiology of Cancer Through In Silico Expression (PRECISE)
Official title: Panomics Relationships in the Epidemiology of Cancer Through In Silico Expression (PRECISE)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cancer
Patients With Clinical and Environmental Risk Factors for Cancer
Patients With a Suspected or Confirmed Diagnosis of Cancer
Lead sponsor: Greater Baltimore Medical Center
Sponsor class: OTHER
First posted: 2017-10-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Patients with Family History of Cancer, whose immediate or extended family member(s) were diagnosed with cancer (20% of the Study Enrollment),
* Patients with Clinical and Environmental Risk Factors for Cancer (20% of the Study Enrollment),
* Patients with a Suspected or Confirmed Diagnosis of Cancer (60% of the Study Enrollment).

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 clinical data from a large cohort of participants from clinical research networks in the United States. In this study, the investigators propose creating a large-scale normalized panomics dataset specifically designed for deep learning-based in silico analysis for biomarker discovery.

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) Patients with Clinical and Environmental Risk Factors for Cancer, and (iii) Patients with a Suspected or Confirmed Diagnosis of Cancer.

Eligibility criteria: 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

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  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

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  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

Primary outcomes:
measure: Panomics Relationships in the Epidemiology of Cancer through In Silico Expression (PRECISE)
timeFrame: 5 years
measure: Panomics Relationships in the Epidemiology of Cancer through In Silico Expression (PRECISE)
timeFrame: 5 years
measure: Panomics Relationships in the Epidemiology of Cancer through In Silico Expression (PRECISE)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
Study officials:
affiliation: Greater Baltimore Medical Center IRB
name: Neri Cohen
role: PRINCIPAL_INVESTIGATOR
References: