Systematic and Mechanism-based Approach to Rational Treatment Trials of Blood Cancer (SMART)
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|ClinicalTrials.gov Identifier: NCT03488641|
Recruitment Status : Recruiting
First Posted : April 5, 2018
Last Update Posted : April 12, 2019
|Condition or disease||Intervention/treatment|
|Hematologic Diseases Treatment||Diagnostic Test: ex-vivo drug response assay|
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.
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Systematic and Mechanism-based Approach to Rational Treatment Trials of Blood Cancer (SMARTrial)|
|Actual Study Start Date :||April 16, 2018|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||March 2023|
- Diagnostic Test: ex-vivo drug response assay
drug sensitivity testing of primary patient derived cancer cells
- Rate of completed drug sensitivity testing [ Time Frame: 7 days ]Patients' sample (blood, bonemarrow aspirate, tissue of lymphnode) will collected on day 0. Ex-vivo drug sensitivity testing will be performed.
- Accuracy of patients' drug response prediction by ex-vivo drug profiling [ Time Frame: from date of inclusion until date of best treatment response (latest 12 months) ]Ex-vivo drug sensitivity categorizes drugs as sensitive/not sensitive. Results will be compared with clinical outcome of patient (response vs. stable disease as defined in the clinical response definition by protocol
- Prediction of time to next treatment [ Time Frame: from date of inclusion until change of treatment (latest 12 months) ]prediction of time to next treatment by a mathematical model based on ex-vivo drug response testing
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03488641
|Contact: Sascha Dietrich, MDfirstname.lastname@example.org|
|Contact: Thorsten Zenz, MDemail@example.com|
|University Hospital Heidelberg||Recruiting|
|Contact: Nora Liebers, MD|
|Principal Investigator:||Sascha Dietrich, MD||University Hospital Heidelberg and DKFZ|