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WithdrawnNCT03304990Updated Jul 22, 2020

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

An observational study in Cancer, Patients With Clinical and Environmental Risk Factors for Cancer and Patients With a Suspected or Confirmed Diagnosis of Cancer, sponsored by Greater Baltimore Medical Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-22.

Sponsored by Greater Baltimore Medical Center · Observational

Why this study was withdrawn
PI has left our Inst.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cancer
  • Patients With Clinical and Environmental Risk Factors for Cancer
  • Patients With a Suspected or Confirmed Diagnosis of Cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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).

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

    <!-- -->

    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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • OtherPatients 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.

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 5 years

  2. Panomics Relationships in the Epidemiology of Cancer through In Silico Expression (PRECISE)

    ● Determine candidate genes and markers underlying cancer and response to treatment.

    Time frame: 5 years

  3. Panomics Relationships in the Epidemiology of Cancer through In Silico Expression (PRECISE)

    ● Discover and validate new detection, prognosis and treatment biomarkers for cancer

    Time frame: 5 years

06

Study locations

1 site
  • Greater Baltimore Medical Center
    Baltimore, Maryland 21204, United States
07

Registry details

Key details

Study ID
NCT03304990
Lead sponsor
Greater Baltimore Medical Center
Responsible party
Sponsor
First posted
Oct 9, 2017
Start date
Nov 29, 2018
Primary completion
Jan 1, 2019
Completion
Jan 1, 2019
Last update
Jul 22, 2020

Study contacts

Neri Cohen
principal investigator · Greater Baltimore Medical Center IRB

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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