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

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.

Study Overview

• Status: Withdrawn
• Conditions: Cancer; Patients With Clinical and Environmental Risk Factors for Cancer; Patients With a Suspected or Confirmed Diagnosis of Cancer
• Intervention / Treatment: Other: Patients with CA or suspected risk of CA or a family Hx

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Greater Baltimore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Family History of CA; Hereditary cancer genetic screening based on risk factors	Other: Patients with CA or suspected risk of CA or a family Hx; Patients with Family History of Cancer, (ii) Patients with Clinical and Environmental Risk Factors for Cancer, (iii) Patients with a Suspected or Confirmed Diagnosis of Cancer.
Risk Factors for CA; No dx of CA	Other: Patients with CA or suspected risk of CA or a family Hx; Patients with Family History of Cancer, (ii) Patients with Clinical and Environmental Risk Factors for Cancer, (iii) Patients with a Suspected or Confirmed Diagnosis of Cancer.
Suspected or Confirmed Diagnosis of CA; Suspected or confirmed diagnosis of cancer	Other: Patients with CA or suspected risk of CA or a family Hx; Patients with Family History of Cancer, (ii) Patients with Clinical and Environmental Risk Factors for Cancer, (iii) Patients with a Suspected or Confirmed Diagnosis of Cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Panomics Relationships in the Epidemiology of Cancer through In Silico Expression (PRECISE)	Establish and maintain a unique repository of blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) collected from thousands of patients 18 years of age or older who have cancer or are at risk of developing cancer.; Discover and validate new detection, prognosis and treatment biomarkers for cancer	5 years
Panomics Relationships in the Epidemiology of Cancer through In Silico Expression (PRECISE)	● Determine candidate genes and markers underlying cancer and response to treatment.	5 years
Panomics Relationships in the Epidemiology of Cancer through In Silico Expression (PRECISE)	● Discover and validate new detection, prognosis and treatment biomarkers for cancer	5 years

Collaborators and Investigators

• Sponsor: Greater Baltimore Medical Center
• Investigators: Principal Investigator: Neri Cohen, Greater Baltimore Medical Center IRB

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2018
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: September 26, 2017
• First Submitted That Met QC Criteria: October 3, 2017
• First Posted (Actual): October 9, 2017

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: PRECISE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No