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

NCT03304990 | Withdrawn

• 1 other identifier: PRECISE
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Patients With Clinical and Environmental Risk Factors for Cancer; Patients With a Suspected or Confirmed Diagnosis of Cancer

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

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

Risk Factors for CA

No dx of CA

Other: Patients with CA or suspected risk of CA or a family Hx

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

Interventions

Patients with CA or suspected risk of CA or a family Hx OTHER

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.

Family History of CA; Risk Factors for CA; Suspected or Confirmed Diagnosis of CA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Greater Baltimore Medical Center: lead

Study Sites (1)

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Collection of saliva and blood

MeSH Terms

Conditions

Neoplasms

Study Officials

• Neri Cohen

  Greater Baltimore Medical Center IRB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: October 9, 2017
• Study Start: November 29, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: July 22, 2020

Record last verified: 2020-07

Locations

US (1)