Assessing the Clinical Benefit of Molecular Profiling in Patients With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03061305|
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : February 24, 2023
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Many patients are treated for advanced cancer without knowledge of underlying molecular features that might indicate FDA approved therapies or potential eligibility for biomarker-selected clinical trials.
The Strata Trial (STR-001-001) has been initiated by Strata Oncology to evaluate the clinical benefit of systematic comprehensive genomic profiling for participants with advanced cancer using real-world data and endpoints, while assessing the proportion of participants available for clinical trials and approved targeted therapies in advanced and/or aggressive cancers. The Strata Trial uses surplus, or leftover, tumor specimens for molecular profiling and does not require additional study-specific procedures.
|Condition or disease|
|Cancer Adult Solid Tumor Lymphoma Multiple Myeloma|
Participants 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 participants identified as having molecular alterations associated with a Strata-affiliated therapeutic clinical trial and/or approved targeted therapy or trials, the Strata reports will provide additional relevant information.
All molecular profiling will be performed in the Strata Oncology CAP-accredited and CLIA-certified laboratory (Ann Arbor, MI). The molecular profiling assays will include tumor-only comprehensive genomic profiling (CGP) by next generation sequencing (NGS) of DNA and RNA covering a range of actionable genomic alterations, such as mutations (e.g. those in EGFR and BRAF), copy number alterations (e.g. ERBB2 amplifications), gene expression, gene fusions (e.g. ALK fusions), tumor mutation burden (TMB) and microsatellite instability status, and may include additional integrative DNA and RNA tests over time.
Participants may be followed for treatment changes and survival for three years from the time of enrollment and/or signed informed consent.
Participants may also be eligible for the Strata Trial Sub-Study at applicable Strata Trial sites. This sub-study is a sample collection study to support the development and evaluation of biomarker assays for patients with solid tumors.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500000 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||An Observational Trial Assessing the Clinical Benefit of Molecular Profiling in Patients With Solid Tumors|
|Actual Study Start Date :||November 2016|
|Estimated Primary Completion Date :||April 2026|
|Estimated Study Completion Date :||April 2026|
- 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
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Subjects must be ≥ 18 years of age.
- Subjects must have histologically documented solid tumors (including lymphoma and multiple myeloma).
Specific criteria for individual tumor types are as follows:
- Participants with gliomas are eligible at any stage of disease
- Participants with pancreatic carcinoma are eligible at any stage of disease
- Participants with rare tumors (i.e. cancer started in an unusual place in the body, it is unusual type and requires special treatment) are eligible at stages II-IV.
- Participants with other tumor types must have recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer.
- Must have an adequate formalin-fixed paraffin-embedded tumor specimen for genomic sequencing.
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|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Strata Oncology|
|Other Study ID Numbers:||
|First Posted:||February 23, 2017 Key Record Dates|
|Last Update Posted:||February 24, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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