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

July 20, 2020 updated by: Greater Baltimore Medical Center
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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Panomics Relationships in the Epidemiology of Cancer through In Silico Expression (PRECISE)
Time Frame: 5 years
  • 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)
Time Frame: 5 years
● 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)
Time Frame: 5 years
● Discover and validate new detection, prognosis and treatment biomarkers for cancer
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Greater Baltimore Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Neri Cohen, Greater Baltimore Medical Center IRB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 29, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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