Study Stopped
Sponsor's discretion to termination due to business decision.
Assessing the Clinical Benefit of Molecular Profiling in Patients With Solid Tumors
An Observational Trial Assessing the Clinical Benefit of Molecular Profiling in Patients With Solid Tumors
1 other identifier
observational
58,213
1 country
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2016
Longer than P75 for all trials
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 15, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2024
CompletedJanuary 31, 2025
January 1, 2025
7.7 years
February 15, 2017
January 28, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Time to Treatment Discontinuation (TTD)
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
3 years
Time to Next Treatment (TTNT)
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
3 years
Secondary Outcomes (2)
biomarker profiles indicative of potential clinical benefit and affiliate trial enrollment
3 years
Correlation between real world endpoints and overall survival endpoint
3 years
Eligibility Criteria
Adult subjects with histologically-documented solid tumors (including lymphoma or multiple myeloma), that have surplus clinical FFPE tumor tissue (e.g. biopsy, fine needle aspiration, fluid cytology, surgical resection) will be eligible for the Strata trial.
You may qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Strata Oncologylead
Study Sites (40)
University of Alabama, Birmingham
Birmingham, Alabama, 35294, United States
Kaiser Permanente - Southern California
Pasadena, California, 91101, United States
Kaiser Permanente - Northern California
Vallejo, California, 94589, United States
SCL Health
Broomfield, Colorado, 80021, United States
Kaiser Permanente Colorado
Denver, Colorado, 80218, United States
Christiana Care Health System
Newark, Delaware, 19713, United States
SwedishAmerican
Rockford, Illinois, 61114, United States
Baptist Health
Lexington, Kentucky, 40503, United States
Christus Health
Lake Charles, Louisiana, 70605, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Kaiser Permanente - Mid-Atlantic
Rockville, Maryland, 20852, United States
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337, United States
Minnesota Oncology - Coon Rapids
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Minnesota Oncology - Maplewood Cancer Center
Maplewood, Minnesota, 55109, United States
St. John's Hospital
Maplewood, Minnesota, 55109, United States
Metro-Minnesota Community Oncology Research Consortium
Minneapolis, Minnesota, 55101, United States
Regions Hospital
Minneapolis, Minnesota, 55101, United States
Minnesota Oncology - Minneapolis
Minneapolis, Minnesota, 55404, United States
North Memorial Health Care
Robbinsdale, Minnesota, 55422, United States
Park Nicollet Health Services
Saint Louis Park, Minnesota, 55416, United States
Minnesota Oncology - Edina
Saint Louis Park, Minnesota, 55435, United States
Minnesota Oncology - Woodbury Clinic
Woodbury, Minnesota, 55125, United States
North Mississippi Medical Center
Tupelo, Mississippi, 38801, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Hayworth Cancer Center
High Point, North Carolina, 27262, United States
UNC REX Healthcare
Raleigh, North Carolina, 27607, United States
Kettering Health Network
Kettering, Ohio, 45429, United States
Kaiser Permanente Northwest
Portland, Oregon, 97227, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
Prisma Health Cancer Institute
Greenville, South Carolina, 29605, United States
Bon Secours St. Francis
Greenville, South Carolina, 29607, United States
UTHealth - Memorial Hemann Cancer Institute
Houston, Texas, 77030, United States
Bon Secours Midlothian
Midlothian, Virginia, 23114, United States
MultiCare
Tacoma, Washington, 98405, United States
Gundersen Health System
La Crosse, Wisconsin, 54601, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Aurora Research Institute
Milwaukee, Wisconsin, 53226, United States
ProHealth Care
Waukesha, Wisconsin, 53188, United States
Related Publications (1)
Tomlins SA, Hovelson DH, Suga JM, Anderson DM, Koh HA, Dees EC, McNulty B, Burkard ME, Guarino M, Khatri J, Safa MM, Matrana MR, Yang ES, Menter AR, Parsons BM, Slim JN, Thompson MA, Hwang L, Edenfield WJ, Nair S, Onitilo A, Siegel R, Miller A, Wassenaar T, Irvin WJ, Schulz W, Padmanabhan A, Harish V, Gonzalez A, Mansoor AH, Kellum A, Harms P, Drewery S, Falkner J, Fischer A, Hipp J, Kwiatkowski K, Lazo de la Vega L, Mitchell K, Reeder T, Siddiqui J, Vakil H, Johnson DB, Rhodes DR. Real-World Performance of a Comprehensive Genomic Profiling Test Optimized for Small Tumor Samples. JCO Precis Oncol. 2021 Aug 19;5:PO.20.00472. doi: 10.1200/PO.20.00472. eCollection 2021 Aug.
PMID: 34476329DERIVED
Biospecimen
leftover tumor tissue, DNA, RNA
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Scott Tomlins, MD
Strata Oncology
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2017
First Posted
February 23, 2017
Study Start
November 1, 2016
Primary Completion
June 27, 2024
Study Completion
June 27, 2024
Last Updated
January 31, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share