Clinical trial NCT03061305: Assessing the Clinical Benefit of Molecular Profiling in Patients With Solid Tumors
Official title: An Observational Trial Assessing the Clinical Benefit of Molecular Profiling in Patients With Solid Tumors
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cancer
Adult Solid Tumor
Lymphoma
Multiple Myeloma
Lead sponsor: Strata Oncology
Sponsor class: INDUSTRY
First posted: 2017-02-23
Enrollment: 58213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to Treatment Discontinuation (TTD)
timeFrame: 3 years
measure: Time to Next Treatment (TTNT)
timeFrame: 3 years
Secondary outcomes:
measure: biomarker profiles indicative of potential clinical benefit and affiliate trial enrollment
timeFrame: 3 years
measure: Correlation between real world endpoints and overall survival endpoint
timeFrame: 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
city: Pasadena
country: United States
facility: Kaiser Permanente - Southern California
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente - Northern California
state: California
city: Broomfield
country: United States
facility: SCL Health
state: Colorado
city: Denver
country: United States
facility: Kaiser Permanente Colorado
state: Colorado
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
city: Rockford
country: United States
facility: SwedishAmerican
state: Illinois
city: Lexington
country: United States
facility: Baptist Health
state: Kentucky
city: Lake Charles
country: United States
facility: Christus Health
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Rockville
country: United States
facility: Kaiser Permanente - Mid-Atlantic
state: Maryland
city: Burnsville
country: United States
facility: Minnesota Oncology - Burnsville
state: Minnesota
city: Coon Rapids
country: United States
facility: Minnesota Oncology - Coon Rapids
state: Minnesota
city: Edina
country: United States
facility: Fairview Southdale Hospital
state: Minnesota
city: Maplewood
country: United States
facility: Minnesota Oncology - Maplewood Cancer Center
state: Minnesota
city: Maplewood
country: United States
facility: St. John's Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Metro-Minnesota Community Oncology Research Consortium
state: Minnesota
city: Minneapolis
country: United States
facility: Regions Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Minnesota Oncology - Minneapolis
state: Minnesota
city: Robbinsdale
country: United States
facility: North Memorial Health Care
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet Health Services
state: Minnesota
city: Saint Louis Park
country: United States
facility: Minnesota Oncology - Edina
state: Minnesota
city: Woodbury
country: United States
facility: Minnesota Oncology - Woodbury Clinic
state: Minnesota
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
city: High Point
country: United States
facility: Hayworth Cancer Center
state: North Carolina
city: Raleigh
country: United States
facility: UNC REX Healthcare
state: North Carolina
city: Kettering
country: United States
facility: Kettering Health Network
state: Ohio
city: Portland
country: United States
facility: Kaiser Permanente Northwest
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health Cancer Institute
state: South Carolina
city: Greenville
country: United States
facility: Bon Secours St. Francis
state: South Carolina
city: Houston
country: United States
facility: UTHealth - Memorial Hemann Cancer Institute
state: Texas
city: Midlothian
country: United States
facility: Bon Secours Midlothian
state: Virginia
city: Tacoma
country: United States
facility: MultiCare
state: Washington
city: La Crosse
country: United States
facility: Gundersen Health System
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Research Institute
state: Wisconsin
city: Waukesha
country: United States
facility: ProHealth Care
state: Wisconsin
Study officials:
affiliation: Strata Oncology
name: Scott Tomlins, MD
role: STUDY_DIRECTOR
References:
citation: 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.