Assessing the Clinical Benefit of Molecular Profiling in Patients With Solid Tumors

  • STATUS
    Recruiting
  • participants needed
    500000
  • sponsor
    Strata Oncology
Updated on 24 February 2022
cancer
lymphoma
multiple myeloma
carcinoma
advanced cancer
primary cancer
glioblastoma multiforme
solid tumour
solid neoplasm

Summary

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.

Description

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.

Details
Condition Cancer, Adult Solid Tumor, Lymphoma, Multiple Myeloma
Clinical Study IdentifierNCT03061305
SponsorStrata Oncology
Last Modified on24 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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