Colorectal NeoplasmNCT04160832
Prevalence and Spectrum of Cancer Susceptibility Among Patients with Advanced Colorectal Polyps
An observational study of Colorectal Neoplasm, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The study is being conducted to determine the prevalence and risk factors for germline cancer susceptibility genetic mutations among patients with advanced colorectal polyps. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Colorectal Neoplasm
- What is being tested?
- Multi-Cancer Cancer Panel
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2019to 30 Aug 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Males and females aged 18 - 89, who have been diagnosed with advanced colorectal polyps.
Who may be able to join
- Provision to sign and date the consent form
- Stated willingness to comply with all study procedures and be available for the duration of the study
- Be a male or female aged 18-89
- Undergone colonoscopy
- At least one advanced colorectal polyp, defined as having any of the following:
- Any polyp ≥ 1cm (adenoma or serrated polyp)
Show all 10Show fewer
- Any polyp with villous architecture
- Any polyp with high-grade dysplasia
- Sessile serrated polyps with any dysplasia
- Traditional serrated adenoma
Who cannot join
- Known hereditary cancer syndrome
- Personal history of inflammatory bowel disease
- Personal history of colorectal cancer
- Polyp histology or size unavailable or not documented
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Prevalence and Spectrum of Germline Cancer Susceptibility Gene Mutations Among Patients with Advanced Colorectal Polyps
The study is being conducted to determine the prevalence and risk factors for germline cancer susceptibility genetic mutations among patients with advanced colorectal polyps.
- Conditions
- Colorectal Neoplasm
- Being tested
- Multi-Cancer Cancer Panel
- Keywords
- genetics, polyps, cancer, multi-gene panel
- Medical subject headings
- Colorectal Neoplasms, Polyps, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Cancer Cancer PanelGenetic
Eligible patients will receive genetic testing to determine germline cancer predisposition.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of germline pathogenic/likely pathogenic variants in cancer predisposition genes in patients with advanced colorectal polyps
Measured: 3 years
Secondary outcomes (1)
Risk factors for germline pathogenic/likely pathogenic variants in patients with advanced colorectal polyps
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start24 Oct 2019
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Swati Patel, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160832
- Sponsor's protocol ID
- 18-2827.cc
- Status last verified
- Jan 2025
- First submitted
- 8 Nov 2019
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Spectrum of Germline Cancer Susceptibility Gene Mutations Among Patients with Advanced Colorectal Polyps
- ClinicalTrials.gov ID
- NCT04160832
- Acronym / sponsor ID
- 18-2827.cc
- Conditions
- Colorectal Neoplasm
- Keywords
- genetics, polyps, cancer, multi-gene panel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 13 Nov 2019 (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 study is being conducted to determine the prevalence and risk factors for germline cancer susceptibility genetic mutations among patients with advanced colorectal polyps.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females aged 18 - 89, who have been diagnosed with advanced colorectal polyps.
Key inclusion criteria (10 listed)
- Provision to sign and date the consent form
- Stated willingness to comply with all study procedures and be available for the duration of the study
- Be a male or female aged 18-89
- Undergone colonoscopy
- At least one advanced colorectal polyp, defined as having any of the following:
Key exclusion criteria (4 listed)
- Known hereditary cancer syndrome
- Personal history of inflammatory bowel disease
- Personal history of colorectal cancer
- Polyp histology or size unavailable or not documented
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 |
|---|---|---|
| Multi-Cancer Cancer PanelEligible patients will receive genetic testing to determine germline cancer predisposition. | Genetic | – |
Primary outcome
Prevalence of germline pathogenic/likely pathogenic variants in cancer predisposition genes in patients with advanced colorectal polyps
Time frame: 3 years
1 secondary outcome
Risk factors for germline pathogenic/likely pathogenic variants in patients with advanced colorectal polyps
Time frame: 3 years
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 15 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Swati Patel, MD principal investigator
University of Colorado, Denver
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 Colorectal Neoplasm, run by University of Colorado, Denver 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 10 inclusion and 4 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 15 Jan 2025. 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 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?
Prevalence of germline pathogenic/likely pathogenic variants in cancer predisposition genes in patients with advanced colorectal polyps (time frame: 3 years). 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 15 Jan 2025.