CancerNCT03304990
Panomics Relationships in the Epidemiology of Cancer Through In Silico Expression (PRECISE)
An observational study of Cancer and Patients With Clinical and Environmental Risk Factors for Cancer, run by Greater Baltimore Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Patients With Clinical and Environmental Risk Factors for Cancer, Patients With a Suspected or Confirmed Diagnosis of Cancer
- What is being tested?
- Patients with CA or suspected risk of CA or a family Hx
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2018to 1 Jan 2019
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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
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- 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
- Men 75-85, with a history of smoking
- 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)
- The patient has signed the appropriate Institutional Review Board approved Informed Consent Form Cancer Patients
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- Ages 18 or older
- Either of the following:
- 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
- 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
- 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
- The patient has signed the appropriate Institutional Review Board approved Informed Consent Form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
About this study
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.
- Conditions
- Cancer, Patients With Clinical and Environmental Risk Factors for Cancer, Patients With a Suspected or Confirmed Diagnosis of Cancer
- Being tested
- Patients with CA or suspected risk of CA or a family Hx
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with CA or suspected risk of CA or a family HxOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Family History of CA | Hereditary cancer genetic screening based on risk factors Receives: Other: Patients with CA or suspected risk of CA or a family Hx | |
| Risk Factors for CA | No dx of CA Receives: 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 Receives: Other: Patients with CA or suspected risk of CA or a family Hx |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start29 Nov 2018
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Why it stopped: PI has left our Inst.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Greater Baltimore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neri Cohen, Principal investigator, Greater Baltimore Medical Center IRB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304990
- Sponsor's protocol ID
- PRECISE
- Status last verified
- Jul 2020
- First submitted
- 26 Sep 2017
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Panomics Relationships in the Epidemiology of Cancer Through In Silico Expression (PRECISE)
- ClinicalTrials.gov ID
- NCT03304990
- Acronym / sponsor ID
- PRECISE
- Conditions
- Cancer, Patients With Clinical and Environmental Risk Factors for Cancer, Patients With a Suspected or Confirmed Diagnosis of Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI has left our Inst.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Greater Baltimore Medical CenterUniversity, hospital or other
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 9 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Family History of CA | – | Other: Patients with CA or suspected risk of CA or a family HxHereditary cancer genetic screening based on risk factors |
| Risk Factors for CA | – | Other: Patients with CA or suspected risk of CA or a family HxNo dx of CA |
| Suspected or Confirmed Diagnosis of CA | – | Other: Patients with CA or suspected risk of CA or a family HxSuspected or confirmed diagnosis of cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (25 listed)
- Patients with Family History of Cancer
- Patients with Clinical \& Environmental Risk Factors for Cancer
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Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients with CA or suspected risk of CA or a family HxPatients 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. | Other | Family History of CA, Risk Factors for CA, Suspected or Confirmed Diagnosis of CA |
Primary outcome
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
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.
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neri Cohen principal investigator
Greater Baltimore Medical Center IRB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Patients With Clinical and Environmental Risk Factors for Cancer, run by Greater Baltimore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Panomics Relationships in the Epidemiology of Cancer through In Silico Expression (PRECISE) (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.