Trials / Completed
CompletedNCT03488641
Systematic and Mechanism-based Approach to Rational Treatment Trials of Blood Cancer
Systematic and Mechanism-based Approach to Rational Treatment Trials of Blood Cancer (SMARTrial)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 80 (actual)
- Sponsor
- German Cancer Research Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This observational study evaluates if drug response testing can be performed within 7 days and analyzes the value of ex-vivo drug screening for hematological malignancies as a biomarker to predict outcome, clinical course and response to treatment.
Detailed description
Targeted treatments have revolutionized care of individual diseases. While a new generation of targeted drugs is emerging in leukemia and lymphoma it remains clinical reality that most genetic information is not used for therapeutic stratification. This is in part based on the shortcomings of traditional biomarker discovery within clinical trials, where throughput is limited in both, drug number and sample size. If it were possible to map the variable pathway dependencies and drug sensitivity patterns in individual patients it is likely to become an asset to identify genotype-phenotype associations, understand the underlying complexities of molecular networks and further precision medicine stratification. To link clinical outcome and ex-vivo drug response assays, the investigators systematically measure pathway sensitivity and resistance of primary tumor cells ex-vivo using a diverse compound library for individual patients in need of treatment. By systematically analyzing ex-vivo drug response patterns, tumors should be functionally grouped, by response phenotype. While for the purpose of this study selection of a specific treatment will not be based on ex-vivo drug response assays, clinical response- and follow-up data of patients will be prospectively collected in parallel.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | ex-vivo drug response assay | drug sensitivity testing of primary patient derived cancer cells |
Timeline
- Start date
- 2018-04-16
- Primary completion
- 2021-07-30
- Completion
- 2021-08-02
- First posted
- 2018-04-05
- Last updated
- 2021-12-01
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03488641. Inclusion in this directory is not an endorsement.