History of Changes for Study: NCT03061305
Profiling Biospecimens From Cancer Patients to Screen for Molecular Alterations Related to Treatment Selection
Latest version (submitted September 28, 2021) on
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Study Record Versions
Version A B Submitted Date Changes
1 February 17, 2017 None (earliest Version on record)
2 November 8, 2017 Study Status, Contacts/Locations and Eligibility
3 November 29, 2017 Contacts/Locations and Study Status
4 May 18, 2018 Contacts/Locations, Study Status and Eligibility
5 May 24, 2018 Contacts/Locations and Study Status
6 December 20, 2018 Study Status and Contacts/Locations
7 June 17, 2019 Study Status and Contacts/Locations
8 October 22, 2019 Study Status
9 March 6, 2020 Contacts/Locations and Study Status
10 January 14, 2021 Study Status, Contacts/Locations, Eligibility, Study Description, Study Identification, Study Design and Conditions
11 September 10, 2021 Contacts/Locations, Study Description and Study Status
12 September 28, 2021 Study Status and Contacts/Locations
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Study NCT03061305
Submitted Date:  February 17, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: STR-001-001
Brief Title: Profiling Biospecimens From Cancer Patients to Screen for Molecular Alterations Related to Treatment Selection
Official Title: Profiling Biospecimens From Cancer Patients to Screen for Molecular Alterations Related to Treatment Selection
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2017
Overall Status: Recruiting
Study Start: November 2016
Primary Completion: April 2020 [Anticipated]
Study Completion:
First Submitted: February 15, 2017
First Submitted that
Met QC Criteria:
February 17, 2017
First Posted: February 23, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
February 17, 2017
Last Update Posted: February 23, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Strata Oncology
Responsible Party: Sponsor
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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. Strata Oncology is initiating the Strata Trial (STR-001-001) with the primary goal of understanding the proportion of subjects available for clinical trials and approved targeted therapies in advanced cancer while assessing the feasibility of using a large-scale NGS screening program to match subjects for eligibility assessments in clinical trials and/or for approved targeted therapies. The Strata Trial does not require additional procedures but rather uses surplus, or leftover tumor specimens for molecular profiling.
Detailed Description:

The Strata Trial is a precision oncology collaboration structured as an observational master screening protocol with the aim to match patients to genomically-guided therapeutic protocols and/or approved therapies. Subjects 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 subjects identified as having molecular variants associated with an affiliated therapeutic protocol and/or approved targeted therapy, the Strata report will provide additional relevant information.

All molecular profiling will be performed in the Strata Oncology CLIA-certified laboratory (Ann Arbor, MI). The molecular profiling assays will include targeted next generation sequencing (NGS) of DNA and RNA covering a range of actionable genomic variants, such as gene mutations (e.g. those in EGFR and BRAF), gene amplifications (e.g. ERBB2) and gene fusions (e.g. ALK).

Subjects who have been identified with genetic alterations relevant to a trial or targeted therapy will be followed for treatment changes for three years from the time of signed informed consent.

Open or close this module Conditions
Conditions: Cancer
Adult Solid Tumor
Open or close this module Study Design
Study Type: Observational [Patient Registry]
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention: Samples With DNA
Biospecimen Description: leftover tumor tissue, DNA, RNA
Enrollment: 100000 [Anticipated]
Number of Groups/Cohorts 0
Target Follow-Up Duration: 3 Years
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
Secondary Outcome Measures:
1. 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.
Open or close this module Eligibility
Study Population: Subjects with advanced (metastatic or unresectable) histologically-documented solid tumors and lymphomas who have surplus FFPE tumor tissue (e.g. biopsy, fine needle aspiration, fluid cytology, surgical resection) available will be eligible for the Strata trial.
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No

Inclusion Criteria:

  • Subjects must be ≥ 18 years of age.
  • Subjects must have histologically documented solid tumors or lymphoma.
  • Subjects must have measurable (>10mm lesion) metastatic disease (i.e. Stage IV) or unresectable disease (e.g. glioblastoma, Stage III pancreatic cancer)
  • Subjects must have ECOG performance status ≤ 2, see Appendix I.
  • Subjects must have an adequate formalin-fixed paraffin-embedded tumor specimen for genomic sequencing.
Open or close this module Contacts/Locations
Central Contact Person: Kat Kwiatkowski, MPH
Telephone: 734-527-0993
Study Officials: Kat Kwiatkowski, MPH
Study Director
Strata Oncology
Locations: United States, Alabama
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294
Contact:Contact: Strata Oncology 734-527-1000
United States, Michigan
Strata Oncology
Ann Arbor, Michigan, United States, 48103
Contact:Contact: 734-527-1000
United States, North Carolina
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Contact:Contact: Strata Oncology 734-527-1000
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services