Profiling Biospecimens From Cancer Patients to Screen for Molecular Alterations Related to Treatment Selection
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03061305|
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : March 9, 2020
|Condition or disease|
|Cancer Adult Solid Tumor Lymphoma|
The Strata Trial is a precision oncology collaboration structured as an observational master screening protocol with the aim to match patients to genomically-guided therapeutic protocols and/or approved therapies. Subjects enrolled on the Strata trial will submit surplus, clinical formalin fixed paraffin-embedded (FFPE) tumor specimens for molecular profiling and a test report will be provided back to the investigator. For those subjects identified as having molecular variants associated with an affiliated therapeutic protocol and/or approved targeted therapy, the Strata report will provide additional relevant information.
All molecular profiling will be performed in the Strata Oncology CLIA-certified laboratory (Ann Arbor, MI). The molecular profiling assays will include targeted next generation sequencing (NGS) of DNA and RNA covering a range of actionable genomic variants, such as gene mutations (e.g. those in EGFR and BRAF), gene amplifications (e.g. ERBB2) and gene fusions (e.g. ALK).
Subjects who have been identified with genetic alterations relevant to a trial or targeted therapy will be followed for treatment changes for three years from the time of signed informed consent.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100000 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||Profiling Biospecimens From Cancer Patients to Screen for Molecular Alterations Related to Treatment Selection|
|Actual Study Start Date :||November 2016|
|Estimated Primary Completion Date :||April 2023|
- Genetic Alteration Frequency [ Time Frame: 3 years ]To evaluate the proportion of subjects across solid tumors and lymphomas having genetic alterations targeted by approved or investigational therapies.
- Assessment of Treatment Selection [ Time Frame: 3 years ]To evaluate the proportion of advanced cancer subjects whose targeted genetic sequencing affected treatment selection and/or clinical trial enrollment.
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): NCT03061305
|Contact: Kat Kwiatkowski, MPHfirstname.lastname@example.org|
|Study Director:||Kat Kwiatkowski, MPH||Strata Oncology|