Pancreatic CancerNCT03073473
Evaluation of the NantHealth GPS Cancer Test in Patients With Advanced Cancers
An observational study of Pancreatic Cancer and Metastatic Breast Cancer, run by Cota Inc. at 10 sites in United States.
Trial summary
Among patients with advanced (metastatic) cancers, detailed characterizations of the tumor utilizing genomic and proteonomic techniques may help guide treatment. It, however, remains unclear if these new diagnostic technologies truly influence clinical and economic outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Metastatic Breast Cancer, Metastatic Lung Cancer
- What is being tested?
- NantHealth GPS Cancer Test
- How many people
- 40 participants
- Where
- 10 sitesUnited States
- Study dates
- 28 Feb 2017to 13 Jun 2018
- 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: Study population is oncology patients consenting to receive active therapy.
Who may be able to join
- Pancreatic cancer patients ineligible for curative surgery at time of entry will be eligible for enrollment.
- Metastatic breast cancer at any time in their treatment history will be eligible for enrollment.
- Advanced stage (non-resectable/metastatic/incurable) lung cancer patients will be eligible for enrollment.
- Metastatic colon cancer patients not amenable to curative therapy will be eligible for enrollment.
- Metastatic non-resectable malignant melanoma patients will be eligible for enrollment.
- NantHealth GPS Cancer in Advanced Cancers
Show all 15Show fewer
- Metastatic hormone refractory prostate cancer patients will be eligible for enrollment. Patients must have tumor tissue available prior to the initiation of the current line of treatment available for GPS Cancer testing.
- Metastatic bladder cancer
- Non-resectable metastatic Renal carcinoma
- Non-resectable metastatic Head and Neck cancer
- Metastatic Ovarian cancer
- Metastatic Cervical cancer
- Metastatic Sarcoma
- Patients must sign informed consent for this study.
- Patients must have private medical insurance coverage through Horizon Blue Cross Blue Shield. This is limited to insured commercial members, including HMO, and excluding, for the avoidance of doubt, members of self-insured customers or Medicare or Medicaid programs.
Who cannot join
- Pregnancy.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
RCCA - Central Jersey Division
East Brunswick, New Jersey, 08816
RCCA - Freehold Division
Freehold, New Jersey, 07728
Hackensack Meridian Health System
Hackensack, New Jersey, 07601
RCCA - Hackettstown Division
Hackettstown, New Jersey, 07840
RCCA - Howell Division
Howell Township, New Jersey, 07731
RCCA - Little Silver Division
Little Silver, New Jersey, 07739
RCCA - Marmora Division
Marmora, New Jersey, 08223
RCCA - Mount Holly Division
Mount Holly, New Jersey, 08060
RCCA - Pompton Plains Division
Pompton Plains, New Jersey, 07444
RCCA - Sparta Division
Sparta, New Jersey, 07871
About this study
Official title: Quantitative Targeted Proteomics Detected by Mass Spectrometry With Whole Genome (DNA) and Whole Transcriptome (RNA) Sequencing in Advanced Cancers
Among patients with advanced (metastatic) cancers, detailed characterizations of the tumor utilizing genomic and proteonomic techniques may help guide treatment. It, however, remains unclear if these new diagnostic technologies truly influence clinical and economic outcomes. This study will evaluate if patients treated according to the results of the NantHealth GPS Cancer test achieve optimal outcomes compared to patients whose treatment are discordant with GPS Cancer recommendations.
Read the detailed description
Personalized Medicine approaches to cancer management require detailed diagnostic evaluations. Broad genomic profiling,using whole genome (DNA) and whole transcriptome(RNA) sequencing platforms,holds the promise of identifying tumor related mutations that are amenable to targeted therapies, with the potential for improved clinical outcomes and lower toxicities compared to traditional cytotoxic chemotherapy. Proteomic approaches may add additional insights into treatment selection by identifying protein biomarkers known to induce drug resistance or indicate drug sensitivity for chemotherapy, monoclonal antibody therapy, hormonal therapy, targeted therapy and immunotherapy. The full value of these approaches has not been realized in routine clinical cancer care.
GPS Cancer™ is a comprehensive test available through NantHealth. GPS Cancer which integrates whole genome (DNA) sequencing, whole transcriptome (RNA) sequencing, and quantitative proteomics through mass spectrometry, provides oncologists with a comprehensive molecular profile of a patient's cancer to inform personalized treatment strategies. GPS Cancer testing is conducted in CLIA-certified and CAP-accredited laboratories.
Hypothesis:
- The addition of proteomics to next generation sequencing (NGS) via the NantHealthGPS Cancer test and the incorporation of whole genome sequencing will identify treatment algorithms with increased likelihood of successful clinical outcomes in patients with advanced cancers.
Study Design(summary):
- The patient population will consist of 160 total individuals with tumor tissue available for NantHealth GPS Cancer testing: (1) pancreatic cancer patients ineligible for curative surgery, (2) metastatic breast cancer, (3) advanced stage (non-resectable/metastatic/incurable) lung cancer, (4) metastatic non-resectable malignant melanoma, (4) metastatic colon cancer not amenable to curative therapy, and (5) metastatic hormone refractory prostate cancer.
- The treating oncologists will declare any planned treatment strategies before the testing results are obtained.These plans will be compared retrospectively with the actual treatment plans delivered to the patient to determine the "change rate".
- The executive steering committee will review the NantHealthGPS Cancer reports and compare the results against the actual delivered therapy. Patients will be segregated into cohorts of "GPS treatment concordant" and "GPS treatment discordant".
- A cohort of patients with similar diseases(matched via the COTA Nodal Address system) will be drawn at a ratio of 3 to 1 from the COTA database.
- The time on chosen therapy (time to treatment failure) will be calculated for the cohort of patients with "GPS treatment concordant", "GPS treatment discordant", and "matched controls". The times will be compared using standard statistical analyses.
- The total cost of care for the three treatment cohorts will also be compared.
- Subjects must possess medical insurance coverage from Horizon Blue Cross Blue Shield of New Jersey in order to participate. A maximum of 160 patient samples will be tested.
- Conditions
- Pancreatic Cancer, Metastatic Breast Cancer, Metastatic Lung Cancer, Metastatic Colon Cancer, Metastatic Melanoma, Metastatic Prostate Cancer
- Being tested
- NantHealth GPS Cancer Test
- Medical subject headings
- Pancreatic Neoplasms, Breast Neoplasms, Lung Neoplasms, Colonic Neoplasms, Melanoma, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NantHealth GPS Cancer TestDiagnostic test
Quantitative targeted proteonomics detected by mass spectrometry with whole genome (DNA) and whole transcriptome (RNA) sequencing.
| Study group | Role | What they receive |
|---|---|---|
| Concordant with GPS Cancer Test | Patients with advanced cancer who undergo GPS Cancer testing whose therapy matches the recommendations from the NantHealth GPS Cancer Test. Receives: Diagnostic Test: NantHealth GPS Cancer Test | |
| Discordant with GPS Cancer Test | Patients with advanced cancer who undergo GPS Cancer testing whose therapy does not match the recommendations from the NantHealth GPS Cancer Test. Receives: Diagnostic Test: NantHealth GPS Cancer Test | |
| CNA controls without testing | Retrospective patients in the COTA database matched by similar characteristics (CNA matched). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time on original treatment strategy for advanced cancer
To determine whether patients who are treated with therapies that are concordant with the NantHealth GPS Cancer test are able to stay on their original treatment strategy longer than patients treated with either discordant regimens or a matched Nanthealth GPS untested population.
Measured: 2 years
Secondary outcomes (1)
Total cost of care
To determine the total 1 year cost of care for patients treated according to the results of the GPS Cancer test compared to discordant regimen treated patients or untested patients.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start28 Feb 2017
- Primary completion13 Jun 2018
- Study completion13 Jun 2018
Why it stopped: Poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cota Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Blue Cross Blue Shield, NantHealth Inc.
- Responsible party
- Sponsor
- Investigators
- Deena Atieh Graham, MD, Principal investigator, Hackensack Meridian Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073473
- Sponsor's protocol ID
- 20170327
- Status last verified
- Jul 2018
- First submitted
- 3 Mar 2017
- Last updated
- 20 Jul 2018
- 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 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Targeted Proteomics Detected by Mass Spectrometry With Whole Genome (DNA) and Whole Transcriptome (RNA) Sequencing in Advanced Cancers
- ClinicalTrials.gov ID
- NCT03073473
- Acronym / sponsor ID
- 20170327
- Conditions
- Pancreatic Cancer, Metastatic Breast Cancer, Metastatic Lung Cancer, Metastatic Colon Cancer, Metastatic Melanoma, Metastatic Prostate Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cota Inc.Industry (pharma, biotech, devices)
- Collaborators
- Blue Cross Blue Shield, NantHealth Inc.
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 13 Jun 2018 (actual)
- Study completion
- 13 Jun 2018 (actual)
- First posted
- 8 Mar 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.
Among patients with advanced (metastatic) cancers, detailed characterizations of the tumor utilizing genomic and proteonomic techniques may help guide treatment. It, however, remains unclear if these new diagnostic technologies truly influence clinical and economic outcomes. This study will evaluate if patients treated according to the results of the NantHealth GPS Cancer test achieve optimal outcomes compared to patients whose treatment are discordant with GPS Cancer recommendations.
Detailed description
Personalized Medicine approaches to cancer management require detailed diagnostic evaluations. Broad genomic profiling,using whole genome (DNA) and whole transcriptome(RNA) sequencing platforms,holds the promise of identifying tumor related mutations that are amenable to targeted therapies, with the potential for improved clinical outcomes and lower toxicities compared to traditional cytotoxic chemotherapy. Proteomic approaches may add additional insights into treatment selection by identifying protein biomarkers known to induce drug resistance or indicate drug sensitivity for chemotherapy, monoclonal antibody therapy, hormonal therapy, targeted therapy and immunotherapy. The full value of these approaches has not been realized in routine clinical cancer care.
GPS Cancer™ is a comprehensive test available through NantHealth. GPS Cancer which integrates whole genome (DNA) sequencing, whole transcriptome (RNA) sequencing, and quantitative proteomics through mass spectrometry, provides oncologists with a comprehensive molecular profile of a patient's cancer to inform personalized treatment strategies. GPS Cancer testing is conducted in CLIA-certified and CAP-accredited laboratories.
Hypothesis:
- The addition of proteomics to next generation sequencing (NGS) via the NantHealthGPS Cancer test and the incorporation of whole genome sequencing will identify treatment algorithms with increased likelihood of successful clinical outcomes in patients with advanced cancers.
Study Design(summary):
- The patient population will consist of 160 total individuals with tumor tissue available for NantHealth GPS Cancer testing: (1) pancreatic cancer patients ineligible for curative surgery, (2) metastatic breast cancer, (3) advanced stage (non-resectable/metastatic/incurable) lung cancer, (4) metastatic non-resectable malignant melanoma, (4) metastatic colon cancer not amenable to curative therapy, and (5) metastatic hormone refractory prostate cancer.
- The treating oncologists will declare any planned treatment strategies before the testing results are obtained.These plans will be compared retrospectively with the actual treatment plans delivered to the patient to determine the "change rate".
- The executive steering committee will review the NantHealthGPS Cancer reports and compare the results against the actual delivered therapy. Patients will be segregated into cohorts of "GPS treatment concordant" and "GPS treatment discordant".
- A cohort of patients with similar diseases(matched via the COTA Nodal Address system) will be drawn at a ratio of 3 to 1 from the COTA database.
- The time on chosen therapy (time to treatment failure) will be calculated for the cohort of patients with "GPS treatment concordant", "GPS treatment discordant", and "matched controls". The times will be compared using standard statistical analyses.
- The total cost of care for the three treatment cohorts will also be compared.
- Subjects must possess medical insurance coverage from Horizon Blue Cross Blue Shield of New Jersey in order to participate. A maximum of 160 patient samples will be tested.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Concordant with GPS Cancer Test | – | Diagnostic Test: NantHealth GPS Cancer TestPatients with advanced cancer who undergo GPS Cancer testing whose therapy matches the recommendations from the NantHealth GPS Cancer Test. |
| Discordant with GPS Cancer Test | – | Diagnostic Test: NantHealth GPS Cancer TestPatients with advanced cancer who undergo GPS Cancer testing whose therapy does not match the recommendations from the NantHealth GPS Cancer Test. |
| CNA controls without testing | – | –Retrospective patients in the COTA database matched by similar characteristics (CNA matched). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population is oncology patients consenting to receive active therapy.
Key inclusion criteria (15 listed)
- Pancreatic cancer patients ineligible for curative surgery at time of entry will be eligible for enrollment.
- Metastatic breast cancer at any time in their treatment history will be eligible for enrollment.
- Advanced stage (non-resectable/metastatic/incurable) lung cancer patients will be eligible for enrollment.
- Metastatic colon cancer patients not amenable to curative therapy will be eligible for enrollment.
- Metastatic non-resectable malignant melanoma patients will be eligible for enrollment.
Key exclusion criteria (1 listed)
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NantHealth GPS Cancer TestQuantitative targeted proteonomics detected by mass spectrometry with whole genome (DNA) and whole transcriptome (RNA) sequencing. | Diagnostic test | Concordant with GPS Cancer Test, Discordant with GPS Cancer Test |
Primary outcome
Time on original treatment strategy for advanced cancer
Time frame: 2 years
To determine whether patients who are treated with therapies that are concordant with the NantHealth GPS Cancer test are able to stay on their original treatment strategy longer than patients treated with either discordant regimens or a matched Nanthealth GPS untested population.
1 secondary outcome
Total cost of care
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- 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.
Deena Atieh Graham, MD principal investigator
Hackensack Meridian Health System
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Metastatic Breast Cancer, run by Cota Inc. at 10 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 15 inclusion and 1 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 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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: Poor accrual). 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 on original treatment strategy for advanced cancer (time frame: 2 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 20 Jul 2018.