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NCT03061305 Clinical Trial

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

Cancer Clinical Trial

Official title:
An Observational Trial Assessing the Clinical Benefit of Molecular Profiling in Patients With Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03061305
Other study ID # STR-001-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2016
Est. completion date April 2026

Study information
Verified date February 2023
Source Strata Oncology
Contact Kat Kwiatkowski, MPH
Phone 734-527-0993
Email kat.kwiatkowski@strataoncology.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500000
Est. completion date April 2026
Est. primary completion date April 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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. - Must have an adequate formalin-fixed paraffin-embedded tumor specimen for genomic sequencing.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Lehigh Valley Health Network Allentown Pennsylvania
United States University of Alabama, Birmingham Birmingham Alabama
United States SCL Health Broomfield Colorado
United States Minnesota Oncology - Burnsville Burnsville Minnesota
United States University of North Carolina, Chapel Hill Chapel Hill North Carolina
United States Minnesota Oncology - Coon Rapids Coon Rapids Minnesota
United States Kaiser Permanente Colorado Denver Colorado
United States Fairview Southdale Hospital Edina Minnesota
United States Bon Secours St. Francis Greenville South Carolina
United States Prisma Health Cancer Institute Greenville South Carolina
United States Hayworth Cancer Center High Point North Carolina
United States UTHealth - Memorial Hemann Cancer Institute Houston Texas
United States Kettering Health Network Kettering Ohio
United States Gundersen Health System La Crosse Wisconsin
United States Christus Health Lake Charles Louisiana
United States Baptist Health Lexington Kentucky
United States University of Wisconsin Madison Wisconsin
United States Minnesota Oncology - Maplewood Cancer Center Maplewood Minnesota
United States St. John's Hospital Maplewood Minnesota
United States Marshfield Clinic Marshfield Wisconsin
United States Bon Secours Midlothian Midlothian Virginia
United States Aurora Research Institute Milwaukee Wisconsin
United States Metro-Minnesota Community Oncology Research Consortium Minneapolis Minnesota
United States Minnesota Oncology - Minneapolis Minneapolis Minnesota
United States Regions Hospital Minneapolis Minnesota
United States Ochsner Clinic Foundation New Orleans Louisiana
United States Christiana Care Health System Newark Delaware
United States Kaiser Permanente - Southern California Pasadena California
United States Kaiser Permanente Northwest Portland Oregon
United States UNC REX Healthcare Raleigh North Carolina
United States North Memorial Health Care Robbinsdale Minnesota
United States SwedishAmerican Rockford Illinois
United States Kaiser Permanente - Mid-Atlantic Rockville Maryland
United States Minnesota Oncology - Edina Saint Louis Park Minnesota
United States Park Nicollet Health Services Saint Louis Park Minnesota
United States MultiCare Tacoma Washington
United States North Mississippi Medical Center Tupelo Mississippi
United States Kaiser Permanente - Northern California Vallejo California
United States ProHealth Care Waukesha Wisconsin
United States Minnesota Oncology - Woodbury Clinic Woodbury Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Strata Oncology

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Genetic Alteration Frequency To evaluate the proportion of subjects across solid tumors and lymphomas having genetic alterations targeted by approved or investigational therapies. 3 years
Secondary Assessment of Treatment Selection To evaluate the proportion of advanced cancer subjects whose targeted genetic sequencing affected treatment selection and/or clinical trial enrollment. 3 years
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