Colorectal Cancer ScreeningCRC screeningNCT00720993
Colorectal Cancer Screening Validation Study
An observational study of Colorectal Cancer Screening, run by IntelliGeneScan, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the gene expression patterns from colorectal mucosal cells collected through the use of a standard anoscope and cytology brush. Patients will include those scheduled for routine colonoscopy procedures and those with confirmed colorectal cancer. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Screening
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to May 2009
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing routine colonoscopy screening or patients scheduled for colorectal cancer surgery.
Who may be able to join
- willing to provide informed consent
- greater than or equal to 50 years of age
- patient is scheduled for routine colonoscopy procedure or colorectal cancer surgery
- subject is willing to provide colorectal mucosal sample for gene expression testing
Who cannot join
- recent radiation or treatment for gynecologic, prostate or rectal cancer
- recent surgery for anal rectal disease
- polys, family or self history of cancer (control group only)
- GI disease
- any mucosal disease or systemic condition that may confound the scientific interpretation of the gene expression results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Altered Gene Expression in Colorectal "Smears" of Individuals With Colon Cancer
The purpose of this study is to evaluate the gene expression patterns from colorectal mucosal cells collected through the use of a standard anoscope and cytology brush. Patients will include those scheduled for routine colonoscopy procedures and those with confirmed colorectal cancer.
- Conditions
- Colorectal Cancer Screening
- Keywords
- Colorectal cancer screening, Gene expression, RTPCR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Control group - patients scheduled for routine colonoscopy procedures with no self or family history or other GI conditions. | |
| 2 | Case group - patients with confirmed colorectal carcinoma scheduled for surgery or observed during routine colonoscopy screening. |
What is being measured
The primary outcome is the main question the study is designed to answer.
- To select a threshold for Mahalanobis distance to determine the best operating characteristics (sensitivity and specificity) in subjects with cancer and subjects without cancer. - To explore other empirical metrics based on previous exploratory data
Measured: Mai 2009
Secondary outcomes (1)
- To obtain data to estimate sensitivity, specificity, and the ROC curve for a test based on M-distance. - To determine the variability of sensitivity and specificity estimates
Measured: Mai 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionMay 2009 (estimated)
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer ScreeningStudies 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
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IntelliGeneScan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BiotechNiks / Molecular Medicine Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720993
- Sponsor's protocol ID
- IGS-08-001
- Acronym
- CRC screening
- Status last verified
- Feb 2009
- First submitted
- 21 Jul 2008
- Last updated
- 23 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altered Gene Expression in Colorectal "Smears" of Individuals With Colon Cancer
- ClinicalTrials.gov ID
- NCT00720993
- Acronym / sponsor ID
- CRC screening / IGS-08-001
- Conditions
- Colorectal Cancer Screening
- Keywords
- Colorectal cancer screening, Gene expression, RTPCR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- IntelliGeneScan, Inc.Industry (pharma, biotech, devices)
- Collaborators
- BiotechNiks / Molecular Medicine Research Institute
- Study start
- Aug 2008
- Primary completion
- May 2009 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 23 Jul 2008 (estimated)
- 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 purpose of this study is to evaluate the gene expression patterns from colorectal mucosal cells collected through the use of a standard anoscope and cytology brush. Patients will include those scheduled for routine colonoscopy procedures and those with confirmed colorectal cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Control group - patients scheduled for routine colonoscopy procedures with no self or family history or other GI conditions. |
| 2 | – | –Case group - patients with confirmed colorectal carcinoma scheduled for surgery or observed during routine colonoscopy screening. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing routine colonoscopy screening or patients scheduled for colorectal cancer surgery.
Key inclusion criteria (4 listed)
- willing to provide informed consent
- greater than or equal to 50 years of age
- patient is scheduled for routine colonoscopy procedure or colorectal cancer surgery
- subject is willing to provide colorectal mucosal sample for gene expression testing
Key exclusion criteria (5 listed)
- recent radiation or treatment for gynecologic, prostate or rectal cancer
- recent surgery for anal rectal disease
- polys, family or self history of cancer (control group only)
- GI disease
- any mucosal disease or systemic condition that may confound the scientific interpretation of the gene expression results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
- To select a threshold for Mahalanobis distance to determine the best operating characteristics (sensitivity and specificity) in subjects with cancer and subjects without cancer. - To explore other empirical metrics based on previous exploratory data
Time frame: Mai 2009
1 secondary outcome
- To obtain data to estimate sensitivity, specificity, and the ROC curve for a test based on M-distance. - To determine the variability of sensitivity and specificity estimates
Time frame: Mai 2009
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2009.
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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 Colorectal Cancer Screening, run by IntelliGeneScan, Inc. 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 4 inclusion and 5 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 Apr 2009. 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?
- To select a threshold for Mahalanobis distance to determine the best operating characteristics (sensitivity and specificity) in subjects with cancer and subjects without cancer. - To explore other empirical metrics based on previous exploratory data (time frame: Mai 2009). 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 2009.