CancerStrataEXPressNCT05312307
Strata EXPress™: A Study Using StrataEXP™ to Identify RNA-Expression Biomarkers in Advanced Cancer Patients
An observational study of Cancer, run by Strata Oncology.
Trial summary
The primary goal of this study is to identify patients with RNA expression profiles consistent with eligibility requirements for therapeutic clinical trials across solid tumors. Left-over tumor tissue will be collected from eligible participants for RNA expression analysis using next-generation sequencing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 6 Feb 2023to 22 Feb 2024
- 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: Participants are male or female ≥ 18 years of age; must have pathologically confirmed advanced, metastatic, or recurrent solid tumor; measurable disease; have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; must meet at least 1 of the following: a. Is/has not adequately responded to standard therapy, or b. For whom no life extending standard therapy exists, or c. Who decline standard therapy, or d. In the opinion of the investigator, is not a candidate for or would be unlikely to tolerate or derive significant clinical benefit from standard therapy; have adequate cardiac, bone marrow, organ function \& laboratory parameters as determined by the treating physician for potential participation in a clinical trial; have leftover formalin-fixed, paraffin-embedded (FFPE) tumor tissue available for StrataEXP testing.
Who may be able to join
- Must be ≥18 years of age,
- Participant must have pathologically confirmed advanced, metastatic, or recurrent solid tumor,
- Measurable disease,
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2,
- Participant must meet at least 1 of the following:
- Is/has not adequately responded to standard therapy, or
Show all 11Show fewer
- For whom no life-extending standard therapy exists, or
- Who decline standard therapy, or
- In the opinion of the investigator, is not a candidate for or would be unlikely to tolerate or derive significant clinical benefit from standard therapy
- Adequate cardiac, bone marrow, organ function \& laboratory parameters as determined by the treating physician for potential participation in a clinical trial,
- Leftover formalin-fixed, paraffin-embedded (FFPE) tumor tissue available for StrataEXP testing
Who cannot join
- Females who are pregnant or nursing,
- History of stroke including transient ischemic attack (TIA) or acute myocardial infarction within 4 months of enrollment,
- Any other clinically significant medical condition that, in the opinion of the treating physician, makes participation in a clinical trial undesirable, including but not limited to ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness.
About this study
The primary goal of this study is to identify patients with RNA expression profiles consistent with eligibility requirements for therapeutic clinical trials across solid tumors. Left-over tumor tissue will be collected from eligible participants for RNA expression analysis using next-generation sequencing.
Read the detailed description
The primary goal of this study is to identify patients with RNA expression profiles consistent with eligibility requirements for therapeutic clinical trials across solid tumors. Left-over tumor tissue will be collected from eligible participants for RNA expression analysis using next-generation sequencing.
A parallel study, StrataPATH™ (STR-004-001), has been developed to support therapeutic hypotheses. Participants may be consented and screened for enrollment separately into StrataPATH with an eligible matching biomarker/drug treatment cohort upon positive identification of a relevant expression signature. Treatment effectiveness of antibody drug conjugates and other targeted therapies will be evaluated in these molecularly defined cohorts.
- Conditions
- Cancer
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify subjects with RNA signatures who may be eligible for clinical trial enrollment
The percentage of participants identified as eligible for therapeutic clinical trials.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start6 Feb 2023
- Primary completion22 Feb 2024
- Study completion22 Feb 2024
Why it stopped: Screening of RNA expression profiles will be integrated directly into the Strata PATH study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Strata Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kat Kwiatkowski, PhD, Study director, Strata Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312307
- Sponsor's protocol ID
- STR-006-001
- Acronym
- StrataEXPress
- Status last verified
- Feb 2024
- First submitted
- 26 Mar 2022
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strata EXPress™: A Study Using StrataEXP™ to Identify RNA-Expression Biomarkers in Advanced Cancer Patients
- ClinicalTrials.gov ID
- NCT05312307
- Acronym / sponsor ID
- StrataEXPress / STR-006-001
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Screening of RNA expression profiles will be integrated directly into the Strata PATH study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Strata OncologyIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 5 Apr 2022 (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.
The primary goal of this study is to identify patients with RNA expression profiles consistent with eligibility requirements for therapeutic clinical trials across solid tumors. Left-over tumor tissue will be collected from eligible participants for RNA expression analysis using next-generation sequencing.
Detailed description
The primary goal of this study is to identify patients with RNA expression profiles consistent with eligibility requirements for therapeutic clinical trials across solid tumors. Left-over tumor tissue will be collected from eligible participants for RNA expression analysis using next-generation sequencing.
A parallel study, StrataPATH™ (STR-004-001), has been developed to support therapeutic hypotheses. Participants may be consented and screened for enrollment separately into StrataPATH with an eligible matching biomarker/drug treatment cohort upon positive identification of a relevant expression signature. Treatment effectiveness of antibody drug conjugates and other targeted therapies will be evaluated in these molecularly defined cohorts.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are male or female ≥ 18 years of age; must have pathologically confirmed advanced, metastatic, or recurrent solid tumor; measurable disease; have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; must meet at least 1 of the following: a. Is/has not adequately responded to standard therapy, or b. For whom no life extending standard therapy exists, or c. Who decline standard therapy, or d. In the opinion of the investigator, is not a candidate for or would be unlikely to tolerate or derive significant clinical benefit from standard therapy; have adequate cardiac, bone marrow, organ function \& laboratory parameters as determined by the treating physician for potential participation in a clinical trial; have leftover formalin-fixed, paraffin-embedded (FFPE) tumor tissue available for StrataEXP testing.
Key inclusion criteria (11 listed)
- Must be ≥18 years of age,
- Participant must have pathologically confirmed advanced, metastatic, or recurrent solid tumor,
- Measurable disease,
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2,
- Participant must meet at least 1 of the following:
Key exclusion criteria (3 listed)
- Females who are pregnant or nursing,
- History of stroke including transient ischemic attack (TIA) or acute myocardial infarction within 4 months of enrollment,
- Any other clinically significant medical condition that, in the opinion of the treating physician, makes participation in a clinical trial undesirable, including but not limited to ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness.
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
To identify subjects with RNA signatures who may be eligible for clinical trial enrollment
Time frame: 5 years
The percentage of participants identified as eligible for therapeutic clinical trials.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- 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.
Kat Kwiatkowski, PhD study director
Strata Oncology
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Strata Oncology.
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 11 inclusion and 3 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: withdrawn, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
To identify subjects with RNA signatures who may be eligible for clinical trial enrollment (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2024.