Non-Small-Cell Lung CancerREVOLUTIONNCT02835599
Registry for the EVolution Of LUng Cancer Therapy Implementation and Outcomes Now
An observational study of Non-Small-Cell Lung Cancer, run by AstraZeneca at 15 sites in United States.
Trial summary
REVOLUTION will be a US multicenter observational registry in scope and governed by a steering committee of approximately 8 experts in NSCLC and outcomes research. The primary goal of the registry is characterizing patterns of use for NSCLC therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-Small-Cell Lung Cancer
- How many people
- 23 participants
- Where
- 15 sitesUnited States
- Study dates
- 1 Nov 2016to 6 Apr 2017
- How long will I take part?
- 5 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients will be enrolled over a three year period across approximately 25 geographically diverse academic as well as community based sites within the US. The five year follow-up period will ensure robust survival data for correlations with clinical, tumor, and treatment variables.
Who may be able to join
- ≥19 years of age
- Patients with a primary diagnosis of NSCLC within the past 5 years who are eligible for their first systemic therapy based on disease characteristics. Systemic therapy may include any cytotoxic, targeted, immune-based, or otherwise non-local treatment modality. Specific allowed settings include the following:
- Incident metastatic disease (stage IV) undergoing palliative therapy
- Non-metastatic disease undergoing adjuvant, neoadjuvant, or concurrent chemoradiation with either curative or palliative intent
- Recurrent or subsequently metastatic disease (any stage)
- Pathologic confirmation of malignancy prior to initiation of first systemic therapy
Show all 10Show fewer
- Submission of archival biospecimen sample(s) (collected up to two years prior) for analysis
- Availability of key variables at the time of screening (e.g. stage, demographics)
- Have been fully informed and are able to provide written consent for longitudinal follow-up and agree to be accessible by phone
- Patients may be concurrently enrolled in unblinded clinical trials, but not blinded clinical trials in which the treatment being administered is unknown
Who cannot join
- Pre-specified enrollment caps have been met (Figure 1)
- Suspected recurrent or subsequently metastatic disease that is not biopsy confirmed prior to receipt of initial systemic therapy
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Research Site
Chicago, Illinois
Research Site
Colorado Springs, Colorado
Research Site
Denver, Colorado
Research Site
Duluth, Minnesota
Research Site
Germantown, Tennessee
Research Site
Jackson, Mississippi
Research Site
Monterey, California
Research Site
Newport News, Virginia
Research Site
Omaha, Nebraska
Research Site
Rochester, Minnesota
Research Site
Rock Hill, South Carolina
Research Site
Santa Rosa, California
Research Site
Southfield, Michigan
Research Site
Tacoma, Washington
Research Site
Urbana, Illinois
About this study
REVOLUTION will be a US multicenter observational registry in scope and governed by a steering committee of approximately 8 experts in NSCLC and outcomes research. The primary goal of the registry is characterizing patterns of use for NSCLC therapy. REVOLUTION will be a multicenter registry enrolling approximately 2,500 patients. Additional patients limited to those with EGFR mutations may be enrolled following the initial study period as needed to ensure adequate sample sizes needed to examine primary questions of interest in the EGFR mutant population. Patients will be enrolled over a three year period across approximately 25 geographically diverse academic as well as community based sites within the US. The five year follow-up period will ensure robust survival data for correlations with clinical, tumor, and treatment variables.
The target of 2,500 patients is meant to ensure adequate numbers of NSCLC patients with particular characteristics of interest including patients with adenocarcinoma, and EGFR mutations and effectively evaluate these patients with respect to key outcomes of interest including overall survival, time to progression, stage at progression, secondary metastases including brain metastases (at diagnosis and progression), comorbidity burden, and performance status at index date.
The study design allows a cross-sectional perspective with collection of detailed patient and clinical characteristics at enrollment followed by longitudinal assessment of clinician and patient-reported endpoints every three months. Centralized follow-up will be conducted by having sites upload patient data following each visit via the web-based data system, with patients who do not show up for site visits being contacted via telephone by the Duke Clinical Research Institute (DCRI) call center. Site recruitment and patient enrollment will be weighted based upon provider specialty and ability to enroll patients with NSCLC with the specified inclusion criteria.
Read the detailed description
REVOLUTION will be a US multicenter observational registry in scope and governed by a steering committee of approximately 8 experts in NSCLC and outcomes research. The primary goal of the registry is characterizing patterns of use for NSCLC therapy. REVOLUTION will be a multicenter registry enrolling approximately 2,500 patients. Additional patients limited to those with EGFR mutations may be enrolled following the initial study period as needed to ensure adequate sample sizes needed to examine primary questions of interest in the EGFR mutant population. Patients will be enrolled over a three year period across approximately 25 geographically diverse academic as well as community based sites within the US. The five year follow-up period will ensure robust survival data for correlations with clinical, tumor, and treatment variables.
The target of 2,500 patients is meant to ensure adequate numbers of NSCLC patients with particular characteristics of interest including patients with adenocarcinoma, and EGFR mutations and effectively evaluate these patients with respect to key outcomes of interest including overall survival, time to progression, stage at progression, secondary metastases including brain metastases (at diagnosis and progression), comorbidity burden, and performance status at index date.
The study design allows a cross-sectional perspective with collection of detailed patient and clinical characteristics at enrollment followed by longitudinal assessment of clinician and patient-reported endpoints every three months. Centralized follow-up will be conducted by having sites upload patient data following each visit via the web-based data system, with patients who do not show up for site visits being contacted via telephone by the Duke Clinical Research Institute (DCRI) call center. Site recruitment and patient enrollment will be weighted based upon provider specialty and ability to enroll patients with NSCLC with the specified inclusion criteria.
Study Patient Selection Criteria
Patients are eligible to be included in the study if they meet all of the following criteria:
- ≥19 years of age
- Patients with a primary diagnosis of NSCLC within the past 5 years who are eligible for their first systemic therapy based on disease characteristics. Systemic therapy may include any cytotoxic, targeted, immune-based, or otherwise non-local treatment modality. Specific allowed settings include the following:
- Incident metastatic disease (stage IV) undergoing palliative therapy
- Non-metastatic disease undergoing adjuvant, neoadjuvant, or concurrent chemoradiation with either curative or palliative intent
- Recurrent or subsequently metastatic disease (any stage)
- Pathologic confirmation of malignancy prior to initiation of first systemic therapy
- Patient agrees to the submission of archival biospecimen sample(s) (collected up to two years prior) for analysis
- Availability of key variables at the time of screening (e.g. stage, demographics)
- Have been fully informed and are able to provide written consent for longitudinal follow-up and agree to be accessible by phone
- Patients may be concurrently enrolled in unblinded clinical trials, but not blinded clinical trials in which the treatment being administered is unknown
Patients are excluded if they meet any of the following criteria:
- Pre-specified enrollment caps have been met (Figure 1)
- Suspected recurrent or subsequently metastatic disease that is not biopsy confirmed prior to receipt of initial systemic therapy
- Conditions
- Non-Small-Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of treatment decisions using molecular testing and results, provider decisions and patient preferences.
Characterize current practice patterns for the care of patients with NSCLC, with a special emphasis on pharmacotherapy (i.e. chemotherapy, targeted agents, and immunotherapy) and patients with EGFR mutated disease. These data will include treatment, molecular test administration and results, provider decisions and patient preferences, and explore the determinants of each.
Measured: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Assessment of progression-free survival
Compare progression-free survival, overall survival, and duration of response associated with targeted therapies, immune checkpoint inhibitors, and cytotoxic chemotherapy in NSCLC and EGFR mutated disease.
Measured: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Assessment of overall survival
Compare progression-free survival, overall survival, and duration of response associated with targeted therapies, immune checkpoint inhibitors, and cytotoxic chemotherapy in NSCLC and EGFR mutated disease.
Measured: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Assessment of treatments.
Compare of progression-free survival, overall survival, and duration of response associated with targeted therapies, immune checkpoint inhibitors, and cytotoxic chemotherapy in NSCLC and EGFR mutated disease.
Measured: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Secondary outcomes (10)
Assessment of billing claims data.
Assessments will be aggregated to quantify total, treatment-related, and toxicity-related health care resource utilization and associated financial burden at the population level (not at the individual patient level) using a three-pronged approach including 1) costs extracted from site billing claims, 2) payments obtained from Medicare claims and 3) both objective and subjective measures of patient financial burden to be collected alongside PROs.
Measured: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Assessment of patient demographics, smoking history and disease characteristics
Characterize the current landscape of actionable mutations in the general clinical population and identify additional factors such as demographics, smoking history, and disease characteristics that predict the presence of actionable mutations as well as the development of T790M mutations in patients with EGFR mutated disease at initial presentation.
Measured: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Assessment of patient hospitalizations.
Assess quality of life (QOL) associated with various treatment regimens and the association of severe complications (i.e. hospitalizations, emergency room visits) with treatment.
Measured: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Assessment of targeted, immune, and cytotoxic therapies
Assess patient reported outcomes associated with commonly used targeted, immune, and cytotoxic therapies and additionally measures of patient reported objective and subjective financial burden as a result of their cancer treatment.
Measured: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Assessment of financial burden related to treatment
Assess patient reported outcomes associated with commonly used targeted, immune, and cytotoxic therapies and additionally measures of patient reported objective and subjective financial burden as a result of their cancer treatment.
Measured: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Assessment of EGFR mutation status.
Characterize and describe the NSCLC patient population as a whole and by EGFR mutation status, with emphasis on demographics and comorbidities.
Measured: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Assessment of molecular markers using tissue specimens.
Bank archived tissue specimens for future assessment of molecular markers identified in this or other relevant studies.
Measured: Time from first patient enrolled up to study completion, approximately 3 years.
Assessment of molecular markers using blood specimens
Analyze other specimens (eg blood) for future assessment of molecular markers.
Measured: Time from first patient enrolled up to study completion, approximately 3 years.
Assessment of costs extracted from site billing claims
Assessments will be aggregated to quantify total, treatment-related, and toxicity-related health care resource utilization and associated financial burden at the population level (not at the individual patient level) using a three-pronged approach including 1) costs extracted from site billing claims, 2) payments obtained from Medicare claims and 3) both objective and subjective measures of patient financial burden to be collected alongside PROs.
Measured: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Assessment of patient financial burden using the Patient reported objective and subjective measures of financial toxicity patient questionnaire
Assessments will be aggregated to quantify total, treatment-related, and toxicity-related health care resource utilization and associated financial burden at the population level (not at the individual patient level) using a three-pronged approach including 1) costs extracted from site billing claims, 2) payments obtained from Medicare claims and 3) both objective and subjective measures of patient financial burden to be collected alongside PROs.
Measured: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study start1 Nov 2016
- Primary completion6 Apr 2017
- Study completion6 Apr 2017
Why it stopped: The study sponsor requested the study be terminated as the existing study design did not meet their needs.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- 23 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffery Crawford, MD, Principal investigator, Duke Clinical Research InstituteEdward Kim, MD, Study chair, Atrium Health Levine Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835599
- Sponsor's protocol ID
- D133FR00110
- Acronym
- REVOLUTION
- Status last verified
- Aug 2017
- First submitted
- 8 Jul 2016
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Sponsor approval to share data is pending.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry for the EVolution Of LUng Cancer Therapy Implementation and Outcomes Now
- ClinicalTrials.gov ID
- NCT02835599
- Acronym / sponsor ID
- REVOLUTION / D133FR00110
- Conditions
- Non-Small-Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study sponsor requested the study be terminated as the existing study design did not meet their needs.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 6 Apr 2017 (actual)
- Study completion
- 6 Apr 2017 (actual)
- First posted
- 18 Jul 2016 (estimated)
- 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.
REVOLUTION will be a US multicenter observational registry in scope and governed by a steering committee of approximately 8 experts in NSCLC and outcomes research. The primary goal of the registry is characterizing patterns of use for NSCLC therapy. REVOLUTION will be a multicenter registry enrolling approximately 2,500 patients. Additional patients limited to those with EGFR mutations may be enrolled following the initial study period as needed to ensure adequate sample sizes needed to examine primary questions of interest in the EGFR mutant population. Patients will be enrolled over a three year period across approximately 25 geographically diverse academic as well as community based sites within the US. The five year follow-up period will ensure robust survival data for correlations with clinical, tumor, and treatment variables.
The target of 2,500 patients is meant to ensure adequate numbers of NSCLC patients with particular characteristics of interest including patients with adenocarcinoma, and EGFR mutations and effectively evaluate these patients with respect to key outcomes of interest including overall survival, time to progression, stage at progression, secondary metastases including brain metastases (at diagnosis and progression), comorbidity burden, and performance status at index date.
The study design allows a cross-sectional perspective with collection of detailed patient and clinical characteristics at enrollment followed by longitudinal assessment of clinician and patient-reported endpoints every three months. Centralized follow-up will be conducted by having sites upload patient data following each visit via the web-based data system, with patients who do not show up for site visits being contacted via telephone by the Duke Clinical Research Institute (DCRI) call center. Site recruitment and patient enrollment will be weighted based upon provider specialty and ability to enroll patients with NSCLC with the specified inclusion criteria.
Detailed description
REVOLUTION will be a US multicenter observational registry in scope and governed by a steering committee of approximately 8 experts in NSCLC and outcomes research. The primary goal of the registry is characterizing patterns of use for NSCLC therapy. REVOLUTION will be a multicenter registry enrolling approximately 2,500 patients. Additional patients limited to those with EGFR mutations may be enrolled following the initial study period as needed to ensure adequate sample sizes needed to examine primary questions of interest in the EGFR mutant population. Patients will be enrolled over a three year period across approximately 25 geographically diverse academic as well as community based sites within the US. The five year follow-up period will ensure robust survival data for correlations with clinical, tumor, and treatment variables.
The target of 2,500 patients is meant to ensure adequate numbers of NSCLC patients with particular characteristics of interest including patients with adenocarcinoma, and EGFR mutations and effectively evaluate these patients with respect to key outcomes of interest including overall survival, time to progression, stage at progression, secondary metastases including brain metastases (at diagnosis and progression), comorbidity burden, and performance status at index date.
The study design allows a cross-sectional perspective with collection of detailed patient and clinical characteristics at enrollment followed by longitudinal assessment of clinician and patient-reported endpoints every three months. Centralized follow-up will be conducted by having sites upload patient data following each visit via the web-based data system, with patients who do not show up for site visits being contacted via telephone by the Duke Clinical Research Institute (DCRI) call center. Site recruitment and patient enrollment will be weighted based upon provider specialty and ability to enroll patients with NSCLC with the specified inclusion criteria.
Study Patient Selection Criteria
Patients are eligible to be included in the study if they meet all of the following criteria:
- ≥19 years of age
- Patients with a primary diagnosis of NSCLC within the past 5 years who are eligible for their first systemic therapy based on disease characteristics. Systemic therapy may include any cytotoxic, targeted, immune-based, or otherwise non-local treatment modality. Specific allowed settings include the following:
- Incident metastatic disease (stage IV) undergoing palliative therapy
- Non-metastatic disease undergoing adjuvant, neoadjuvant, or concurrent chemoradiation with either curative or palliative intent
- Recurrent or subsequently metastatic disease (any stage)
- Pathologic confirmation of malignancy prior to initiation of first systemic therapy
- Patient agrees to the submission of archival biospecimen sample(s) (collected up to two years prior) for analysis
- Availability of key variables at the time of screening (e.g. stage, demographics)
- Have been fully informed and are able to provide written consent for longitudinal follow-up and agree to be accessible by phone
- Patients may be concurrently enrolled in unblinded clinical trials, but not blinded clinical trials in which the treatment being administered is unknown
Patients are excluded if they meet any of the following criteria:
- Pre-specified enrollment caps have been met (Figure 1)
- Suspected recurrent or subsequently metastatic disease that is not biopsy confirmed prior to receipt of initial systemic therapy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be enrolled over a three year period across approximately 25 geographically diverse academic as well as community based sites within the US. The five year follow-up period will ensure robust survival data for correlations with clinical, tumor, and treatment variables.
Key inclusion criteria (10 listed)
- ≥19 years of age
- Patients with a primary diagnosis of NSCLC within the past 5 years who are eligible for their first systemic therapy based on disease characteristics. Systemic therapy may include any cytotoxic, targeted, immune-based, or otherwise non-local treatment modality. Specific allowed settings include the following:
- Pathologic confirmation of malignancy prior to initiation of first systemic therapy
- Submission of archival biospecimen sample(s) (collected up to two years prior) for analysis
- Availability of key variables at the time of screening (e.g. stage, demographics)
Key exclusion criteria (2 listed)
- Pre-specified enrollment caps have been met (Figure 1)
- Suspected recurrent or subsequently metastatic disease that is not biopsy confirmed prior to receipt of initial systemic therapy
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
Assessment of treatment decisions using molecular testing and results, provider decisions and patient preferences.
Time frame: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Characterize current practice patterns for the care of patients with NSCLC, with a special emphasis on pharmacotherapy (i.e. chemotherapy, targeted agents, and immunotherapy) and patients with EGFR mutated disease. These data will include treatment, molecular test administration and results, provider decisions and patient preferences, and explore the determinants of each.
Assessment of progression-free survival
Time frame: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Compare progression-free survival, overall survival, and duration of response associated with targeted therapies, immune checkpoint inhibitors, and cytotoxic chemotherapy in NSCLC and EGFR mutated disease.
Assessment of overall survival
Time frame: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Compare progression-free survival, overall survival, and duration of response associated with targeted therapies, immune checkpoint inhibitors, and cytotoxic chemotherapy in NSCLC and EGFR mutated disease.
Assessment of treatments.
Time frame: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Compare of progression-free survival, overall survival, and duration of response associated with targeted therapies, immune checkpoint inhibitors, and cytotoxic chemotherapy in NSCLC and EGFR mutated disease.
10 secondary outcomes
Assessment of billing claims data.
Time frame: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Assessment of patient demographics, smoking history and disease characteristics
Time frame: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Assessment of patient hospitalizations.
Time frame: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Assessment of targeted, immune, and cytotoxic therapies
Time frame: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Assessment of financial burden related to treatment
Time frame: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Assessment of EGFR mutation status.
Time frame: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Assessment of molecular markers using tissue specimens.
Time frame: Time from first patient enrolled up to study completion, approximately 3 years.
Assessment of molecular markers using blood specimens
Time frame: Time from first patient enrolled up to study completion, approximately 3 years.
Assessment of costs extracted from site billing claims
Time frame: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Assessment of patient financial burden using the Patient reported objective and subjective measures of financial toxicity patient questionnaire
Time frame: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Results and safety
The study was stopped early (reason given: The study sponsor requested the study be terminated as the existing study design did not meet their needs.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- D133FR00110\_CSR\_SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Sponsor approval to share data is pending.
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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.
Jeffery Crawford, MD principal investigator
Duke Clinical Research Institute
Edward Kim, MD study chair
Atrium Health Levine Cancer Institute
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small-Cell Lung Cancer, run by AstraZeneca at 15 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 10 inclusion and 2 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 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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: The study sponsor requested the study be terminated as the existing study design did not meet their needs.). 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?
Assessment of treatment decisions using molecular testing and results, provider decisions and patient preferences. (time frame: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.). The study lists 4 primary outcomes in all. 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 22 Aug 2017.