Clinical trial · Observational
Metabolomics-Based Detection of Colorectal Cancer
NCT00507598CI-TRIAL-00015588metabolomicscompletedClinicalTrials.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 collect specimens to perform metabolic profiling of serum and urine from patients with colorectal cancer, colon polyps and healthy patients.
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 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- •Perform metabolic profiling of tissue,serum & urine from pts w/ colorectal cancer (stages I-IV), healthy controls & pts w/ colorectal polyps & correlate results.
- timeFrame
- 1 years
Secondary outcomes (1)
- measure
- Correlate changes of serum & urine biomarkers /p trt to predict response or toxicity,& correlate w/other treatment outcomes. Compare the metabolic profile between pts w/various stages of colorectal cancer.
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with resectable colorectal cancer must have samples collected (serum/urine) prior to surgery and/or after surgery, but prior to starting chemotherapy. * Patients with metastatic colorectal cancer must have samples collected prior to initiating chemotherapy, and after chemotherapy initiation: every 3 months for up to 24 months. * Subjects must be ≥ 18 years of age. * Subjects undergoing screening colonoscopy are able to participate as healthy controls or as patients with colon polyps if colonoscopy identifies colon polyps being present (informed consent will be signed first and samples will be collected; after colonoscopy the samples will be identified as "healthy" or "polyps"). * For patients who underwent biopsy or surgery for colorectal cancer, enough tissue needs to be available for testing, as appropriate per patients groups in the protocol Schema. * Subjects must be able to attend follow up or treatment visits per investigator's recommendations for up to 24 months for collection of serum/urine specimens. * Female patients known to be pregnant are not eligible for this protocol. * Subjects must be able to undergo an 8-hr overnight fast prior to metabolomic testing Exclusion Criteria: * Presence of an invasive cancer other than colorectal cancer is an exclusion criterion
References
Publications (0)
Data not yet available
No reference posted for this study.