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

Terminated

• Conditions: Adult Solid Tumor; Cancer; Lymphoma; Multiple Myeloma

• Registration Number: NCT03061305
• Lead Sponsor: Strata Oncology

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-02-17
• Study First Posted: 2017-02-23
• Primary Completion: 2024-06-27
• Study Completion: 2024-06-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 58213

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:

  1. Participants with gliomas are eligible at any stage of disease
  2. Participants with pancreatic carcinoma are eligible at any stage of disease
  3. 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.
  4. Participants with other tumor types must have recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer.
  5. 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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to Treatment Discontinuation (TTD)	3 years	To evaluate TTD for participants who received an anticancer biomarker-guided therapy and, when available, as compared to prior TTD from prior anti-cancer therapy
Time to Next Treatment (TTNT)	3 years	To evaluate TTNT for participants who received and anticancer biomarker guided therapy and, when available, as compared to prior TTNT from prior anti-cancer therapy

Secondary Outcome Measures

Name	Time	Method
biomarker profiles indicative of potential clinical benefit and affiliate trial enrollment	3 years	To evaluate the proportion of participants with actionable genomic profiles that indicate a potential clinical benefit from standard of care biomarker-guided therapies or a clinical trial, and the proportion of participants who enroll on a clinical trial.
Correlation between real world endpoints and overall survival endpoint	3 years	To assess the correlation between real world endpoints and overall survival endpoint

Trial Locations

Locations (40)

University of Alabama, Birmingham; 🇺🇸 Birmingham, Alabama, United States

Kaiser Permanente - Southern California; 🇺🇸 Pasadena, California, United States

Kaiser Permanente - Northern California; 🇺🇸 Vallejo, California, United States

SCL Health; 🇺🇸 Broomfield, Colorado, United States

Kaiser Permanente Colorado; 🇺🇸 Denver, Colorado, United States

Christiana Care Health System; 🇺🇸 Newark, Delaware, United States

SwedishAmerican; 🇺🇸 Rockford, Illinois, United States

Baptist Health; 🇺🇸 Lexington, Kentucky, United States

Christus Health; 🇺🇸 Lake Charles, Louisiana, United States

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States

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