Colon CancerNCT03322176
Healthcare Decisions Post-Testing, Risk-reducing and Preventative Strategies Using LYNCH Genetic Testing Reducing, and Preventative Strategies Using LYNCH Genetic Testing
An observational study of Colon Cancer and Endometrial Cancer, run by Data Collection Analysis Business Management at 1 site in United States.
Trial summary
Increase surveillance for LYNCH Syndrome Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer, Endometrial Cancer
- What is being tested?
- Genetic testing
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2017to 1 Nov 2020
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: collecting data and reviewing the Principal Investigators' (P.I.) Standard Operating Procedures (SOP) on Lynch genetic testing and changes made to their specific SOP.
Who may be able to join
- Must be a Medical Practitioner
- Medical Doctor (MD)
- Doctor of Osteopathic (DO)
- Physician Assistant (PA)
- Advanced Practice Registered Nurse (APRN)
- Nurse Practitioner (NP)
- Must have a current standard operating procedure that includes obtaining/reviewing medical history and family medical history.
Who cannot join
- Government-funded insurance data cannot be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medical Provider Experience Assessment Healthcare Decisions Post-Testing, Risk-Reducing, and Preventative Strategies Using LYNCH Genetic Testing
Increase surveillance for LYNCH Syndrome
Read the detailed description
The purpose of this minimal risk, observational survey is to increase surveillance for Lynch Syndrome (hereditary non-polyposis colon cancer), Colorectal, and Endometrial cancer, also to determine targeted risk-reducing and preventative strategies.
- Conditions
- Colon Cancer, Endometrial Cancer
- Being tested
- Genetic testing
- Medical subject headings
- Colonic Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic testingOther
LYNCH genetic testing
What is being measured
The primary outcome is the main question the study is designed to answer.
Provider Structures and Processes
Plan of Care Changes due to LYNCH genetic testing. Provider based observational survey system on the health and well-being of patients and populations
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start17 Oct 2017
- Primary completion17 Oct 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Data Collection Analysis Business Management
- Sponsor type
- University, hospital or other
- Collaborators
- PAS Research Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322176
- Sponsor's protocol ID
- PAS1461
- Status last verified
- Jan 2019
- First submitted
- 24 Oct 2017
- Last updated
- 23 Jan 2019
- Results posted
- No
- 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 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Provider Experience Assessment Healthcare Decisions Post-Testing, Risk-Reducing, and Preventative Strategies Using LYNCH Genetic Testing
- ClinicalTrials.gov ID
- NCT03322176
- Acronym / sponsor ID
- PAS1461
- Conditions
- Colon Cancer, Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Data Collection Analysis Business ManagementUniversity, hospital or other
- Collaborators
- PAS Research Services
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 17 Oct 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 26 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.
Increase surveillance for LYNCH Syndrome
Detailed description
The purpose of this minimal risk, observational survey is to increase surveillance for Lynch Syndrome (hereditary non-polyposis colon cancer), Colorectal, and Endometrial cancer, also to determine targeted risk-reducing and preventative strategies.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- collecting data and reviewing the Principal Investigators' (P.I.) Standard Operating Procedures (SOP) on Lynch genetic testing and changes made to their specific SOP.
Key inclusion criteria (7 listed)
- Must be a Medical Practitioner
- Must have a current standard operating procedure that includes obtaining/reviewing medical history and family medical history.
Key exclusion criteria (1 listed)
- Government-funded insurance data cannot be included in 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 |
|---|---|---|
| Genetic testingLYNCH genetic testing | Other | – |
Primary outcome
Provider Structures and Processes
Time frame: 36 months
Plan of Care Changes due to LYNCH genetic testing. Provider based observational survey system on the health and well-being of patients and populations
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Colon Cancer and Endometrial Cancer, run by Data Collection Analysis Business Management 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 7 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: status not confirmed, as of the sponsor's last update on 23 Jan 2019. 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?
Results are not available in the source record.
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?
Provider Structures and Processes (time frame: 36 months). 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 Jan 2019.