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Profiling Biospecimens From Cancer Patients to Screen for Molecular Alterations Related to Treatment Selection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03061305
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : March 9, 2020
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 March 9, 2020
Actual Study Start Date November 2016
Estimated Primary Completion Date April 2023   (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 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
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.

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 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.
Condition
  • Cancer
  • Adult Solid Tumor
  • Lymphoma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   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: February 17, 2017)
100000
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date April 2023   (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 or lymphoma.
  • Specific criteria for individual tumor types are as follows:

    1. Subjects with glioblastoma.
    2. Subjects with pancreatic cancer are eligible at any stage of disease.
    3. Subjects 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. Subjects with other tumor types must have recurrent, relapsed, refractory, metastatic or advanced stages III or IV cancer.
  • Subjects 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
Responsible Party Strata Oncology
Study Sponsor Strata Oncology
Collaborators Not Provided
Investigators
Study Director: Kat Kwiatkowski, MPH Strata Oncology
PRS Account Strata Oncology
Verification Date March 2020