Clinical trial · Observational
Detection of MSI in Circulating Tumor DNA of Colorectal Carcinoma Patients
Detection of Microsatellite Instability (MSI) in Circulating Tumor DNA of Patients With Stage IV Colorectal Carcinoma
NCT03594448CI-TRIAL-00080305terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient accrual
Summary
Brief summary (as posted)
This pilot trial studies how well serial liquid biopsies work in detecting microsatellite instability in participants with stage IV colorectal cancer. Serial liquid biopsies may help doctors learn better methods to track cancer in the bloodstream and how to use these to improve cancer treatments.
Conditions
Conditions (2)
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 Stage IV | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Microsatellite Instability | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Serial Liquid Biopsy | Procedure | — | UNRESOLVED |
| Specimen Collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ancillary-correlative (Specimen collection)
- description
- Participants undergo collection of blood samples in addition to the usual amount collected when they come in for their regular cancer treatments or doctor?s appointment every 6-8 weeks until disease progression or stopping at 9 months.
- interventionNames
- Procedure: Specimen Collection
- Procedure: Serial Liquid Biopsy
Primary outcomes (1)
- measure
- Correlation between presence of MSI present in circulating tumor DNA versus in primary tumor specimens
- timeFrame
- Up to 1 year
- description
- MSI testing distinguishes between tumors into one of 3 phenotypic categories: MSI-High (MSI-H) is reported when \> 30% of biomarkers show instability; Microsatellite stable (MSS) is reported in the absence of instability. The third category, MSI-Low (MSI-L) is diagnostically equivalent to MSS, and is reported when MSI is present in \< 30% of biomarkers. MSI status will be determined by polymerase chain reaction (PCR) using commercial kits provided by Promega.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients newly diagnosed with stage IV colorectal cancer and with defined microsatellite instability status before initiation of systemic immunotherapy. * Trackable cancer-driver mutation in the primary tumor documented before initiation of chemotherapy. * Zubrod performance status of 0 or 1. * Patients have measurable disease according to RECIST version (v)1.1. * Ability to understand and willing to sign a written informed consent. Exclusion Criteria: * Severe anemia (hemoglobin \[Hb\] \< 8 g/dL).
References
Publications (0)
Data not yet available
No reference posted for this study.