<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03304990</url>
  </required_header>
  <id_info>
    <org_study_id>PRECISE</org_study_id>
    <nct_id>NCT03304990</nct_id>
  </id_info>
  <brief_title>Panomics Relationships in the Epidemiology of Cancer Through In Silico Expression (PRECISE)</brief_title>
  <official_title>Panomics Relationships in the Epidemiology of Cancer Through In Silico Expression (PRECISE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Greater Baltimore Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Greater Baltimore Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      PRECISE is a study to discover new detection, prognosis and treatment biomarkers for cancer.&#xD;
      This is a prospective, multi-center, observational study designed to collect de-identified&#xD;
      biospecimens and clinical data from a large cohort of participants from clinical research&#xD;
      networks in the United States. In this study, the investigators propose creating a&#xD;
      large-scale normalized panomics dataset specifically designed for deep learning-based in&#xD;
      silico analysis for biomarker discovery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will enroll all subjects who are eligible and willing to participate with a goal&#xD;
      of enrolling at least 10,000 in several categories: (i) Patients with Family History of&#xD;
      Cancer, (ii) Patients with Clinical and Environmental Risk Factors for Cancer, and (iii)&#xD;
      Patients with a Suspected or Confirmed Diagnosis of Cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    PI has left our Inst.&#xD;
  </why_stopped>
  <start_date type="Actual">November 29, 2018</start_date>
  <completion_date type="Actual">January 1, 2019</completion_date>
  <primary_completion_date type="Actual">January 1, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Panomics Relationships in the Epidemiology of Cancer through In Silico Expression (PRECISE)</measure>
    <time_frame>5 years</time_frame>
    <description>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.&#xD;
Discover and validate new detection, prognosis and treatment biomarkers for cancer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Panomics Relationships in the Epidemiology of Cancer through In Silico Expression (PRECISE)</measure>
    <time_frame>5 years</time_frame>
    <description>● Determine candidate genes and markers underlying cancer and response to treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Panomics Relationships in the Epidemiology of Cancer through In Silico Expression (PRECISE)</measure>
    <time_frame>5 years</time_frame>
    <description>● Discover and validate new detection, prognosis and treatment biomarkers for cancer</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Cancer</condition>
  <condition>Patients With Clinical and Environmental Risk Factors for Cancer</condition>
  <condition>Patients With a Suspected or Confirmed Diagnosis of Cancer</condition>
  <arm_group>
    <arm_group_label>Family History of CA</arm_group_label>
    <description>Hereditary cancer genetic screening based on risk factors</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Risk Factors for CA</arm_group_label>
    <description>No dx of CA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Suspected or Confirmed Diagnosis of CA</arm_group_label>
    <description>Suspected or confirmed diagnosis of cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patients with CA or suspected risk of CA or a family Hx</intervention_name>
    <description>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.</description>
    <arm_group_label>Family History of CA</arm_group_label>
    <arm_group_label>Risk Factors for CA</arm_group_label>
    <arm_group_label>Suspected or Confirmed Diagnosis of CA</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Collection of saliva and blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        -  Patients with Family History of Cancer, whose immediate or extended family member(s)&#xD;
             were diagnosed with cancer (20% of the Study Enrollment),&#xD;
&#xD;
          -  Patients with Clinical and Environmental Risk Factors for Cancer (20% of the Study&#xD;
             Enrollment),&#xD;
&#xD;
          -  Patients with a Suspected or Confirmed Diagnosis of Cancer (60% of the Study&#xD;
             Enrollment).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with Family History of Cancer&#xD;
&#xD;
               1. Ages 18 or older&#xD;
&#xD;
               2. Either of the following:&#xD;
&#xD;
                    1. Patients with two or more first, second or third degree blood relatives on&#xD;
                       the same side of the family diagnosed with cancer&#xD;
&#xD;
                    2. Patients with one or more first, second or third degree blood relative with&#xD;
                       male breast cancer&#xD;
&#xD;
                    3. Patients with a first, second, or third degree blood relative with a known&#xD;
                       BRCA1 or BRCA2 mutation&#xD;
&#xD;
                    4. Patients with a first, second, or third degree blood relative who has had&#xD;
                       colorectal or endometrial cancer diagnosed before age 50 years&#xD;
&#xD;
                    5. Patients with first degree relatives with a known deleterious APC, MEN1,&#xD;
                       MUTYH, PTEN, RET, STK11, TP53, or VHL gene mutation&#xD;
&#xD;
                    6. Patients of Ashkenazi Jewish descent with one or more first degree relatives&#xD;
                       or two or more second degree relatives with breast, ovarian or colorectal&#xD;
                       cancer&#xD;
&#xD;
               3. The patient has signed the appropriate Institutional Review Board approved&#xD;
                  Informed Consent Form&#xD;
&#xD;
                  Patients with Clinical &amp; Environmental Risk Factors for Cancer&#xD;
&#xD;
               1. Either of the following:&#xD;
&#xD;
                    1. Women 21 or older&#xD;
&#xD;
                    2. Men 50-75&#xD;
&#xD;
                    3. Men 75-85, with a history of smoking&#xD;
&#xD;
               2. At least one guideline recommended cancer screening test documented in the&#xD;
                  medical record, if indicated for age and gender (eg, pap smear, mammography, low&#xD;
                  dose chest CT and/or colonoscopy)&#xD;
&#xD;
               3. The patient has signed the appropriate Institutional Review Board approved&#xD;
                  Informed Consent Form Cancer Patients&#xD;
&#xD;
               1. Ages 18 or older&#xD;
&#xD;
               2. Either of the following:&#xD;
&#xD;
                    1. New diagnosis of histologically confirmed cancer (any stage I-IV, as well as&#xD;
                       carcinoma in situ (CIS)), across multiple solid tumor types with no prior&#xD;
                       systemic cancer therapy and scheduled for surgical resection or non-surgical&#xD;
                       management&#xD;
&#xD;
                    2. Or, subjects with a high suspicion for cancer diagnosis by clinical and&#xD;
                       radiological assessment, but without preceding histologic diagnosis, are&#xD;
                       eligible, if they have not received prior systemic cancer therapy and are&#xD;
                       scheduled for surgery&#xD;
&#xD;
               3. Has or will have a medically obtained pathological tumor specimen from core&#xD;
                  needle or surgical biopsy and/or surgical resection within 4 weeks (28 days) of&#xD;
                  study blood draw and pre-treatment&#xD;
&#xD;
               4. The patient has signed the appropriate Institutional Review Board approved&#xD;
                  Informed Consent Form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Blood or blood product transfusion in the preceding 2 months 2. Cognitive&#xD;
             impairment as determined by clinical history 3. Pregnant women (by self-report of&#xD;
             pregnancy status) 4. Inability to speak English 5. Previous diagnosis of cancer&#xD;
             except: non-melanomatous skin cancer 6. Poor health status or unfit to tolerate blood&#xD;
             draw&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neri Cohen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Greater Baltimore Medical Center IRB</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Greater Baltimore Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03304990
org study id: PRECISE
nct id: NCT03304990
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Panomics Relationships in the Epidemiology of Cancer through In Silico Expression (PRECISE)
time frame: 5 years
description: 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
measure: Panomics Relationships in the Epidemiology of Cancer through In Silico Expression (PRECISE)
time frame: 5 years
description: ● Determine candidate genes and markers underlying cancer and response to treatment.
measure: Panomics Relationships in the Epidemiology of Cancer through In Silico Expression (PRECISE)
time frame: 5 years
description: ● Discover and validate new detection, prognosis and treatment biomarkers for cancer
arm group label: Family History of CA
description: Hereditary cancer genetic screening based on risk factors
arm group label: Risk Factors for CA
description: No dx of CA
arm group label: Suspected or Confirmed Diagnosis of CA
description: Suspected or confirmed diagnosis of cancer
intervention type: Other
intervention name: Patients with CA or suspected risk of CA or a family Hx
description: 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.
arm group label: Family History of CA
arm group label: Risk Factors for CA
arm group label: Suspected or Confirmed Diagnosis of CA
Collection of saliva and blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Neri Cohen
role: Principal Investigator
affiliation: Greater Baltimore Medical Center IRB
facility: 
country: United States
responsible party type: Sponsor