Clinical trial · Interventional
Comparison of KRAS/BRAF Mutational Status With Conventional Techniques and Plasma Samples Analysis
Comparison of KRAS/BRAF Mutational Status Between Tumor Tissue Section Analysis With Conventional Techniques and Plasma Samples Analysis (KPLEX2)
NCT02784639CI-TRIAL-00023347KPLEX2completedN/AClinicalTrials.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 goal of this multicenter prospective study is to validate, and ultimately translate in routine clinical practice, the use of plasma analysis of ccfDNA for the determination of KRAS mutation status in mCRC 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Plasma Analysis of circulating cell free DNA | Other | — | UNRESOLVED |
| Tumor tissue analysis of circulating cell free DNA | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- determination of KRAS mutation
- description
- circulating cell free DNA (ccfDNA) plasma analysis
- interventionNames
- Other: Plasma Analysis of circulating cell free DNA
- Other: Tumor tissue analysis of circulating cell free DNA
Primary outcomes (1)
- measure
- Area under ROC curve
- timeFrame
- 12 month
- description
- Area under the ROC curve of the mutation percentage obtained from plasma ccfDNA analysis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Histologically confirmed diagnosis of colorectal cancer * Synchronous or metachronous metastatic colorectal cancer * Patient for whom the KRAS status is requested for therapeutic decision-making * Male or female ≥ 18 years old * Patients must be affiliated to a Social Security System * Patient information and written informed consent form signed prior to any study specific procedures Exclusion Criteria: * History of other malignancy within the previous 5 years (except for appropriately treated carcinoma in situ of the cervix and non-melanoma skin carcinoma) * Blood transfusion within 1 week prior to blood collection * Patients having received any chemotherapy or/and radiotherapy within 15 days prior to blood collection * Patients with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * Legal incapacity or limited legal capacity
References
Publications (0)
Data not yet available
No reference posted for this study.