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



Status:Recruiting
Conditions:Cancer, Cancer, Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/26/2018
Start Date:November 2016
Contact:Kat Kwiatkowski, MPH
Email:kat.kwiatkowski@strataoncology.com
Phone:734-527-0993

Use our guide to learn which trials are right for you!

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.

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.

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.
We found this trial at
29
sites
Raleigh, North Carolina 27607
Phone: 734-527-1000
2218
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Raleigh, NC
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
1777
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Birmingham, AL
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Chapel Hill, North Carolina 27599
(919) 962-2211
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
2189
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Chapel Hill, NC
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Burnsville, Minnesota 55337
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Coon Rapids, Minnesota 55433
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Denver, Colorado 80205
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Denver, CO
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6401 France Ave S
Edina, Minnesota 55435
(952) 924-5000
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Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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Edina, MN
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302 West Westwood Avenue
High Point, North Carolina 27262
Phone: 734-527-1000
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High Point, NC
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Houston, Texas 77030
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Houston, TX
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Kettering, Ohio 45429
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Kettering, OH
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1900 South Avenue
La Crosse, Wisconsin 54601
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La Crosse, WI
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Madison, Wisconsin 53792
(608) 263-2400
Phone: 734-527-1000
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Madison, WI
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Maplewood, Minnesota 55109
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Maplewood, MN
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Maplewood, Minnesota 55109
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Milwaukee, Wisconsin 53215
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Milwaukee, WI
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Minneapolis, Minnesota 55101
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Minneapolis, MN
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640 Jackson Street
Minneapolis, Minnesota 55101
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910 East 26th Street
Minneapolis, Minnesota 55404
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New Orleans, Louisiana 70121
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New Orleans, LA
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Newark, Delaware 19713
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Portland, Oregon 97227
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Portland, OR
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Robbinsdale, Minnesota 55422
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Saint Louis Park, Minnesota 55416
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Saint Louis Park, Minnesota 55435
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Tacoma, Washington 98405
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Tacoma, WA
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Tupelo, Mississippi 38801
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Tupelo, MS
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975 Sereno Drive
Vallejo, California 94589
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Waukesha, Wisconsin 53188
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Woodbury, Minnesota 55125
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