Colorectal CancerNICENCT05445570
Non-invasive Identification of Colorectal Cancer and Adenomas in Early Stages
An observational study of Colorectal Cancer, run by Venn Biosciences Corporation at 12 sites in United States.
Trial summary
The NICE study is a prospective, multi-site study to train and validate a blood-based, glycoproteomic test for the early detection of advanced adenoma and colorectal cancer by collecting blood samples and associated relevant clinical information from average-risk participants who undergo routine screening colonoscopy… Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Non-Interventional
- How many people
- 3,002 participants
- Where
- 12 sitesUnited States
- Study dates
- 13 May 2022to 19 Mar 2024
- 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 45 to 85 years
- All sexes
- Adult, Older adult
Study population: The study population comprises approximately 3000 subjects, male and female, between the ages of 45 and 85 who are scheduled for or will soon be scheduled for a screening, surveillance, or diagnostic colonoscopy.
Who may be able to join
- Male or female subjects between the ages of 45-85.
- Able to provide an informed consent and who understand and agree to all study procedures required
- Subject is scheduled or will soon be scheduled to receive a colonoscopy as ordered by their doctor.
Who cannot join
- Any active malignancy
- Any other illness that in the opinion of the investigator, makes the subject not a good candidate for the study.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Encore - Fleming Island Center for Clinical Research
Fleming Island, Florida, 32003
Allied Health Clinical Research Organization
Freehold, New Jersey, 07728
Paragon Rx Clinical
Garden Grove, California, 92840
Encore - Nature Coast Clinical Research
Inverness, Florida, 34452
Encore - Westside Center for Clinical Research
Jacksonville, Florida, 32205
Encore Borland Groover
Jacksonville, Florida, 32256
Combined Gastro Research, LLC
Lafayette, Louisiana, 70503
Blue Ridge Medical Research
Lynchburg, Virginia, 24502
East View Medical Research, LLD
Mobile, Alabama, 36606
Encore - St. Johns Center for Clinical Research
Saint Augustine, Florida, 32086
Paragon Rx Clinical
Santa Ana, California, 92703
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105
About this study
The NICE study is a prospective, multi-site study to train and validate a blood-based, glycoproteomic test for the early detection of advanced adenoma and colorectal cancer by collecting blood samples and associated relevant clinical information from average-risk participants who undergo routine screening colonoscopy as well as participants undergoing colonoscopy for surveillance or diagnostic indications
Read the detailed description
InterVenn is using its glycoprotein profiling technology platform that couples high-resolution liquid chromatography (LC)-mass spectrometry (MS) with an artificial intelligence (AI), neural network (NN)-based high-throughput data processing software to identify patterns uniquely associated with colon adenoma and colon adenocarcinoma in order to detect (pre)cancerous events early. The purpose of this prospective multi-center observational study is to train and validate a blood-based, glycoproteomic test for the early detection of advanced adenoma and colorectal cancer by collecting blood samples and associated relevant clinical information from average-risk participants who undergo routine screening colonoscopy as well as participants undergoing colonoscopy for surveillance or diagnostic indications.
- Conditions
- Colorectal Cancer
- Being tested
- Non-Interventional
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalDiagnostic test
This is an observational, non interventional study
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the InterVenn test
To determine the sensitivity of the InterVenn test
Measured: up to 90 days from baseline
Specificity of the InterVenn test
To determine the specificity of the InterVenn test
Measured: up to 90 days from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start13 May 2022
- Primary completion19 Mar 2024
- Study completion19 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,002 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venn Biosciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Hommes, MD, Study director, InterVenn Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445570
- Sponsor's protocol ID
- NICE-001
- Acronym
- NICE
- Status last verified
- Aug 2023
- First submitted
- 21 Apr 2022
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Identification of Colorectal Cancer and Adenomas in Early Stages
- ClinicalTrials.gov ID
- NCT05445570
- Acronym / sponsor ID
- NICE / NICE-001
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,002 participants (actual)
- Lead sponsor
- Venn Biosciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 13 May 2022 (actual)
- Primary completion
- 19 Mar 2024 (actual)
- Study completion
- 19 Mar 2024 (actual)
- First posted
- 6 Jul 2022 (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.
The NICE study is a prospective, multi-site study to train and validate a blood-based, glycoproteomic test for the early detection of advanced adenoma and colorectal cancer by collecting blood samples and associated relevant clinical information from average-risk participants who undergo routine screening colonoscopy as well as participants undergoing colonoscopy for surveillance or diagnostic indications
Detailed description
InterVenn is using its glycoprotein profiling technology platform that couples high-resolution liquid chromatography (LC)-mass spectrometry (MS) with an artificial intelligence (AI), neural network (NN)-based high-throughput data processing software to identify patterns uniquely associated with colon adenoma and colon adenocarcinoma in order to detect (pre)cancerous events early. The purpose of this prospective multi-center observational study is to train and validate a blood-based, glycoproteomic test for the early detection of advanced adenoma and colorectal cancer by collecting blood samples and associated relevant clinical information from average-risk participants who undergo routine screening colonoscopy as well as participants undergoing colonoscopy for surveillance or diagnostic indications.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population comprises approximately 3000 subjects, male and female, between the ages of 45 and 85 who are scheduled for or will soon be scheduled for a screening, surveillance, or diagnostic colonoscopy.
Key inclusion criteria (3 listed)
- Male or female subjects between the ages of 45-85.
- Able to provide an informed consent and who understand and agree to all study procedures required
- Subject is scheduled or will soon be scheduled to receive a colonoscopy as ordered by their doctor.
Key exclusion criteria (2 listed)
- Any active malignancy
- Any other illness that in the opinion of the investigator, makes the subject not a good candidate for the study.
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 |
|---|---|---|
| Non-InterventionalThis is an observational, non interventional study | Diagnostic test | – |
Primary outcome
Sensitivity of the InterVenn test
Time frame: up to 90 days from baseline
To determine the sensitivity of the InterVenn test
Specificity of the InterVenn test
Time frame: up to 90 days from baseline
To determine the specificity of the InterVenn test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Sponsor WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. No individual participant data will be shared.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Daniel Hommes, MD study director
InterVenn Biosciences
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Venn Biosciences Corporation at 12 sites 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity of the InterVenn test (time frame: up to 90 days from baseline). The study lists 2 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 23 Apr 2024.