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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. Identifier: NCT03061305
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : March 9, 2020
Information provided by (Responsible Party):
Strata Oncology

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.

Condition or disease
Cancer Adult Solid Tumor Lymphoma

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Profiling Biospecimens From Cancer Patients to Screen for Molecular Alterations Related to Treatment Selection
Actual Study Start Date : November 2016
Estimated Primary Completion Date : April 2023

Resource links provided by the National Library of Medicine

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.

Biospecimen Retention:   Samples With DNA
leftover tumor tissue, DNA, RNA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03061305

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Contact: Kat Kwiatkowski, MPH 734-527-0993

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Sponsors and Collaborators
Strata Oncology
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Study Director: Kat Kwiatkowski, MPH Strata Oncology
Additional Information:

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Responsible Party: Strata Oncology Identifier: NCT03061305    
Other Study ID Numbers: STR-001-001
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: March 9, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No