Clinical trial · Observational
Colorectal Cancer Screening Validation Study
Altered Gene Expression in Colorectal "Smears" of Individuals With Colon Cancer
NCT00720993CI-TRIAL-00002248CRC screeningunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Screening | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- 1
- description
- Control group - patients scheduled for routine colonoscopy procedures with no self or family history or other GI conditions.
- label
- 2
- description
- Case group - patients with confirmed colorectal carcinoma scheduled for surgery or observed during routine colonoscopy screening.
Primary outcomes (1)
- 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
- timeFrame
- Mai 2009
Secondary outcomes (1)
- measure
- - 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.