CancerNCT03061305
Assessing the Clinical Benefit of Molecular Profiling in Patients With Solid Tumors
An observational study of Cancer and Adult Solid Tumor, run by Strata Oncology at 40 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Adult Solid Tumor, Lymphoma
- How many people
- 58,213 participants
- Where
- 40 sitesUnited States
- Study dates
- Nov 2016to 27 Jun 2024
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects with histologically-documented solid tumors (including lymphoma or multiple myeloma), that have surplus clinical FFPE tumor tissue (e.g. biopsy, fine needle aspiration, fluid cytology, surgical resection) will be eligible for the Strata trial.
Who may be able to join
- 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:
- Participants with gliomas are eligible at any stage of disease
- Participants with pancreatic carcinoma are eligible at any stage of disease
- 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.
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- Participants with other tumor types must have recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer.
- 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.
Who cannot join
None listed.
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
University of Alabama, Birmingham
Birmingham, Alabama, 35294
SCL Health
Broomfield, Colorado, 80021
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27514
Minnesota Oncology - Coon Rapids
Coon Rapids, Minnesota, 55433
Kaiser Permanente Colorado
Denver, Colorado, 80218
Fairview Southdale Hospital
Edina, Minnesota, 55435
Prisma Health Cancer Institute
Greenville, South Carolina, 29605
Bon Secours St. Francis
Greenville, South Carolina, 29607
Hayworth Cancer Center
High Point, North Carolina, 27262
UTHealth - Memorial Hemann Cancer Institute
Houston, Texas, 77030
Kettering Health Network
Kettering, Ohio, 45429
Gundersen Health System
La Crosse, Wisconsin, 54601
Christus Health
Lake Charles, Louisiana, 70605
Baptist Health
Lexington, Kentucky, 40503
University of Wisconsin
Madison, Wisconsin, 53792
Minnesota Oncology - Maplewood Cancer Center
Maplewood, Minnesota, 55109
St. John's Hospital
Maplewood, Minnesota, 55109
Marshfield Clinic
Marshfield, Wisconsin, 54449
Bon Secours Midlothian
Midlothian, Virginia, 23114
Aurora Research Institute
Milwaukee, Wisconsin, 53226
Metro-Minnesota Community Oncology Research Consortium
Minneapolis, Minnesota, 55101
Regions Hospital
Minneapolis, Minnesota, 55101
Minnesota Oncology - Minneapolis
Minneapolis, Minnesota, 55404
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Christiana Care Health System
Newark, Delaware, 19713
Kaiser Permanente - Southern California
Pasadena, California, 91101
Kaiser Permanente Northwest
Portland, Oregon, 97227
UNC REX Healthcare
Raleigh, North Carolina, 27607
North Memorial Health Care
Robbinsdale, Minnesota, 55422
SwedishAmerican
Rockford, Illinois, 61114
Kaiser Permanente - Mid-Atlantic
Rockville, Maryland, 20852
Park Nicollet Health Services
Saint Louis Park, Minnesota, 55416
Minnesota Oncology - Edina
Saint Louis Park, Minnesota, 55435
MultiCare
Tacoma, Washington, 98405
North Mississippi Medical Center
Tupelo, Mississippi, 38801
Kaiser Permanente - Northern California
Vallejo, California, 94589
ProHealth Care
Waukesha, Wisconsin, 53188
Minnesota Oncology - Woodbury Clinic
Woodbury, Minnesota, 55125
About this study
Official title: An Observational Trial Assessing the Clinical Benefit of Molecular Profiling in Patients With Solid Tumors
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.
Read the detailed description
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.
Participants may also be eligible for the Strata Trial Sub-Study at applicable Strata Trial sites. This sub-study is a sample collection study to support the development and evaluation of biomarker assays for patients with solid tumors.
- Conditions
- Cancer, Adult Solid Tumor, Lymphoma, Multiple Myeloma
- Medical subject headings
- Neoplasms, Lymphoma, Multiple Myeloma
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Treatment Discontinuation (TTD)
To evaluate TTD for participants who received an anticancer biomarker-guided therapy and, when available, as compared to prior TTD from prior anti-cancer therapy
Measured: 3 years
Time to Next Treatment (TTNT)
To evaluate TTNT for participants who received and anticancer biomarker guided therapy and, when available, as compared to prior TTNT from prior anti-cancer therapy
Measured: 3 years
Secondary outcomes (2)
biomarker profiles indicative of potential clinical benefit and affiliate trial enrollment
To evaluate the proportion of participants with actionable genomic profiles that indicate a potential clinical benefit from standard of care biomarker-guided therapies or a clinical trial, and the proportion of participants who enroll on a clinical trial.
Measured: 3 years
Correlation between real world endpoints and overall survival endpoint
To assess the correlation between real world endpoints and overall survival endpoint
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startNov 2016
- Primary completion27 Jun 2024
- Study completion27 Jun 2024
Why it stopped: Sponsor's discretion to termination due to business decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58,213 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Strata Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Tomlins, MD, Study director, Strata Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061305
- Sponsor's protocol ID
- STR-001-001
- Status last verified
- Jan 2025
- First submitted
- 15 Feb 2017
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tomlins SA, Hovelson DH, Suga JM, Anderson DM, Koh HA, Dees EC, McNulty B, Burkard ME, Guarino M, Khatri J, Safa MM, Matrana MR, Yang ES, Menter AR, Parsons BM, Slim JN, Thompson MA, Hwang L, Edenfield WJ, Nair S, Onitilo A, Siegel R, Miller A, Wassenaar T, Irvin WJ, Schulz W, Padmanabhan A, Harish V, Gonzalez A, Mansoor AH, Kellum A, Harms P, Drewery S, Falkner J, Fischer A, Hipp J, Kwiatkowski K, Lazo de la Vega L, Mitchell K, Reeder T, Siddiqui J, Vakil H, Johnson DB, Rhodes DR. Real-World Performance of a Comprehensive Genomic Profiling Test Optimized for Small Tumor Samples. JCO Precis Oncol. 2021 Aug 19;5:PO.20.00472. doi: 10.1200/PO.20.00472. eCollection 2021 Aug.
PubMed 34476329
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Trial Assessing the Clinical Benefit of Molecular Profiling in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT03061305
- Acronym / sponsor ID
- STR-001-001
- Conditions
- Cancer, Adult Solid Tumor, Lymphoma, Multiple Myeloma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor's discretion to termination due to business decision.
- Enrolment
- 58,213 participants (actual)
- Lead sponsor
- Strata OncologyIndustry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Participants may also be eligible for the Strata Trial Sub-Study at applicable Strata Trial sites. This sub-study is a sample collection study to support the development and evaluation of biomarker assays for patients with solid tumors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects with histologically-documented solid tumors (including lymphoma or multiple myeloma), that have surplus clinical FFPE tumor tissue (e.g. biopsy, fine needle aspiration, fluid cytology, surgical resection) will be eligible for the Strata trial.
Key inclusion criteria (9 listed)
- 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:
- Must have an adequate formalin-fixed paraffin-embedded tumor specimen for genomic sequencing.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to Treatment Discontinuation (TTD)
Time frame: 3 years
To evaluate TTD for participants who received an anticancer biomarker-guided therapy and, when available, as compared to prior TTD from prior anti-cancer therapy
Time to Next Treatment (TTNT)
Time frame: 3 years
To evaluate TTNT for participants who received and anticancer biomarker guided therapy and, when available, as compared to prior TTNT from prior anti-cancer therapy
2 secondary outcomes
biomarker profiles indicative of potential clinical benefit and affiliate trial enrollment
Time frame: 3 years
Correlation between real world endpoints and overall survival endpoint
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Sponsor's discretion to termination due to business decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Derived from this study: PubMed 34476329Tomlins SA, Hovelson DH, Suga JM, Anderson DM, Koh HA, Dees EC, McNulty B, Burkard ME, Guarino M, Khatri J, Safa MM, Matrana MR, Yang ES, Menter AR, Parsons BM, Slim JN, Thompson MA, Hwang L, Edenfield WJ, Nair S, Onitilo A, Siegel R, Miller A, Wassenaar T, Irvin WJ, Schulz W, Padmanabhan A, Harish V, Gonzalez A, Mansoor AH, Kellum A, Harms P, Drewery S, Falkner J, Fischer A, Hipp J, Kwiatkowski K, Lazo de la Vega L, Mitchell K, Reeder T, Siddiqui J, Vakil H, Johnson DB, Rhodes DR. Real-World Performance of a Comprehensive Genomic Profiling Test Optimized for Small Tumor Samples. JCO Precis Oncol. 2021 Aug 19;5:PO.20.00472. doi: 10.1200/PO.20.00472. eCollection 2021 Aug.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Tomlins, MD study director
Strata Oncology
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Adult Solid Tumor, run by Strata Oncology at 40 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor's discretion to termination due to business decision.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Treatment Discontinuation (TTD) (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03061305, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.