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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03061305
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Strata Oncology
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Kat Kwiatkowski, MPH
Principal Investigator Affiliation Strata Oncology
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cancer, Adult Solid Tumor, Lymphoma, Multiple Myeloma
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama, Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama, Birmingham

Birmingham, Alabama, 35294

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

Kaiser Permanente - Southern California, Pasadena, California

Status

Recruiting

Address

Kaiser Permanente - Southern California

Pasadena, California, 91101

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

Kaiser Permanente - Northern California, Vallejo, California

Status

Recruiting

Address

Kaiser Permanente - Northern California

Vallejo, California, 94589

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

SCL Health, Broomfield, Colorado

Status

Recruiting

Address

SCL Health

Broomfield, Colorado, 80021

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

Kaiser Permanente Colorado, Denver, Colorado

Status

Recruiting

Address

Kaiser Permanente Colorado

Denver, Colorado, 80218

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

Christiana Care Health System, Newark, Delaware

Status

Recruiting

Address

Christiana Care Health System

Newark, Delaware, 19713

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

SwedishAmerican, Rockford, Illinois

Status

Recruiting

Address

SwedishAmerican

Rockford, Illinois, 61114

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

Baptist Health, Lexington, Kentucky

Status

Recruiting

Address

Baptist Health

Lexington, Kentucky, 40503

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

Ochsner Clinic Foundation, New Orleans, Louisiana

Status

Recruiting

Address

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

Kaiser Permanente - Mid-Atlantic, Rockville, Maryland

Status

Recruiting

Address

Kaiser Permanente - Mid-Atlantic

Rockville, Maryland, 20852

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

Minnesota Oncology - Burnsville, Burnsville, Minnesota

Status

Recruiting

Address

Minnesota Oncology - Burnsville

Burnsville, Minnesota, 55337

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

Minnesota Oncology - Coon Rapids, Coon Rapids, Minnesota

Status

Recruiting

Address

Minnesota Oncology - Coon Rapids

Coon Rapids, Minnesota, 55433

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

Fairview Southdale Hospital, Edina, Minnesota

Status

Recruiting

Address

Fairview Southdale Hospital

Edina, Minnesota, 55435

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

Maplewood, Minnesota

Status

Recruiting

Address

Minnesota Oncology - Maplewood Cancer Center

Maplewood, Minnesota, 55109

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

St. John's Hospital, Maplewood, Minnesota

Status

Recruiting

Address

St. John's Hospital

Maplewood, Minnesota, 55109

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

Minneapolis, Minnesota

Status

Recruiting

Address

Metro-Minnesota Community Oncology Research Consortium

Minneapolis, Minnesota, 55101

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

Regions Hospital, Minneapolis, Minnesota

Status

Recruiting

Address

Regions Hospital

Minneapolis, Minnesota, 55101

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

Minnesota Oncology - Minneapolis, Minneapolis, Minnesota

Status

Recruiting

Address

Minnesota Oncology - Minneapolis

Minneapolis, Minnesota, 55404

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

North Memorial Health Care, Robbinsdale, Minnesota

Status

Recruiting

Address

North Memorial Health Care

Robbinsdale, Minnesota, 55422

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

Park Nicollet Health Services, Saint Louis Park, Minnesota

Status

Recruiting

Address

Park Nicollet Health Services

Saint Louis Park, Minnesota, 55416

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

Minnesota Oncology - Edina, Saint Louis Park, Minnesota

Status

Recruiting

Address

Minnesota Oncology - Edina

Saint Louis Park, Minnesota, 55435

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

Minnesota Oncology - Woodbury Clinic, Woodbury, Minnesota

Status

Recruiting

Address

Minnesota Oncology - Woodbury Clinic

Woodbury, Minnesota, 55125

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

North Mississippi Medical Center, Tupelo, Mississippi

Status

Recruiting

Address

North Mississippi Medical Center

Tupelo, Mississippi, 38801

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

Chapel Hill, North Carolina

Status

Recruiting

Address

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27514

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

Hayworth Cancer Center, High Point, North Carolina

Status

Recruiting

Address

Hayworth Cancer Center

High Point, North Carolina, 27262

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

UNC REX Healthcare, Raleigh, North Carolina

Status

Recruiting

Address

UNC REX Healthcare

Raleigh, North Carolina, 27607

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

Kettering Health Network, Kettering, Ohio

Status

Recruiting

Address

Kettering Health Network

Kettering, Ohio, 45429

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

Kaiser Permanente Northwest, Portland, Oregon

Status

Completed

Address

Kaiser Permanente Northwest

Portland, Oregon, 97227

Lehigh Valley Health Network, Allentown, Pennsylvania

Status

Recruiting

Address

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

Prisma Health Cancer Institute, Greenville, South Carolina

Status

Completed

Address

Prisma Health Cancer Institute

Greenville, South Carolina, 29605

Bon Secours St. Francis, Greenville, South Carolina

Status

Recruiting

Address

Bon Secours St. Francis

Greenville, South Carolina, 29607

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

Houston, Texas

Status

Recruiting

Address

UTHealth - Memorial Hemann Cancer Institute

Houston, Texas, 77030

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

Bon Secours Midlothian, Midlothian, Virginia

Status

Recruiting

Address

Bon Secours Midlothian

Midlothian, Virginia, 23114

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

MultiCare, Tacoma, Washington

Status

Recruiting

Address

MultiCare

Tacoma, Washington, 98405

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

Gundersen Health System, La Crosse, Wisconsin

Status

Recruiting

Address

Gundersen Health System

La Crosse, Wisconsin, 54601

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

University of Wisconsin, Madison, Wisconsin

Status

Recruiting

Address

University of Wisconsin

Madison, Wisconsin, 53792

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

Marshfield Clinic, Marshfield, Wisconsin

Status

Recruiting

Address

Marshfield Clinic

Marshfield, Wisconsin, 54449

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000

Aurora Research Institute, Milwaukee, Wisconsin

Status

Completed

Address

Aurora Research Institute

Milwaukee, Wisconsin, 53226

ProHealth Care, Waukesha, Wisconsin

Status

Recruiting

Address

ProHealth Care

Waukesha, Wisconsin, 53188

Site Contact

Strata Oncology

kat.kwiatkowski@strataoncology.com

734-527-1000