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

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ClinicalTrials.gov Identifier: NCT03061305
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : September 29, 2021
Sponsor:
Information provided by (Responsible Party):
Strata Oncology

Tracking Information
First Submitted Date February 15, 2017
First Posted Date February 23, 2017
Last Update Posted Date September 29, 2021
Actual Study Start Date November 2016
Estimated Primary Completion Date April 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 17, 2017)
Genetic Alteration Frequency [ Time Frame: 3 years ]
To evaluate the proportion of subjects across solid tumors and lymphomas having genetic alterations targeted by approved or investigational therapies.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 17, 2017)
Assessment of Treatment Selection [ Time Frame: 3 years ]
To evaluate the proportion of advanced cancer subjects whose targeted genetic sequencing affected treatment selection and/or clinical trial enrollment.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Retention:   Samples With DNA
Description:
leftover tumor tissue, DNA, RNA
Sampling Method Non-Probability Sample
Study Population Subjects with histologically-documented solid tumors (including lymphoma or multiple myeloma), and have surplus clinical FFPE tumor tissue (e.g. biopsy, fine needle aspiration, fluid cytology, surgical resection) will be eligible for the Strata trial.
Condition
  • Cancer
  • Adult Solid Tumor
  • Lymphoma
  • Multiple Myeloma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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. pii: PO.20.00472. doi: 10.1200/PO.20.00472. eCollection 2021 Aug.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 14, 2021)
500000
Original Estimated Enrollment
 (submitted: February 17, 2017)
100000
Study Completion Date Not Provided
Estimated Primary Completion Date April 2026   (Final data collection date for primary outcome measure)
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.
  • Must have an adequate formalin-fixed paraffin-embedded tumor specimen for genomic sequencing.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Kat Kwiatkowski, MPH 734-527-0993 kat.kwiatkowski@strataoncology.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03061305
Other Study ID Numbers STR-001-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Strata Oncology
Original Responsible Party Same as current
Current Study Sponsor Strata Oncology
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Kat Kwiatkowski, MPH Strata Oncology
PRS Account Strata Oncology
Verification Date September 2021