Study Stopped
Poor accrual
Evaluation of the NantHealth GPS Cancer Test in Patients With Advanced Cancers
Quantitative Targeted Proteomics Detected by Mass Spectrometry With Whole Genome (DNA) and Whole Transcriptome (RNA) Sequencing in Advanced Cancers
1 other identifier
observational
40
1 country
10
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2017
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 28, 2017
CompletedFirst Submitted
Initial submission to the registry
March 3, 2017
CompletedFirst Posted
Study publicly available on registry
March 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 13, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 13, 2018
CompletedJuly 20, 2018
July 1, 2018
1.3 years
March 3, 2017
July 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
2 years
Secondary Outcomes (1)
Total cost of care
1 year
Other Outcomes (1)
Physician behavior
2 years
Study Arms (3)
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.
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.
CNA controls without testing
Retrospective patients in the COTA database matched by similar characteristics (CNA matched).
Interventions
Quantitative targeted proteonomics detected by mass spectrometry with whole genome (DNA) and whole transcriptome (RNA) sequencing.
Eligibility Criteria
Study population is oncology patients consenting to receive active therapy.
You may qualify if:
- 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
- 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.
You may not qualify if:
- Pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cota Inc.lead
- Blue Cross Blue Shieldcollaborator
- NantHealth Inc.collaborator
Study Sites (10)
RCCA - Central Jersey Division
East Brunswick, New Jersey, 08816, United States
RCCA - Freehold Division
Freehold, New Jersey, 07728, United States
Hackensack Meridian Health System
Hackensack, New Jersey, 07601, United States
RCCA - Hackettstown Division
Hackettstown, New Jersey, 07840, United States
RCCA - Howell Division
Howell Township, New Jersey, 07731, United States
RCCA - Little Silver Division
Little Silver, New Jersey, 07739, United States
RCCA - Marmora Division
Marmora, New Jersey, 08223, United States
RCCA - Mount Holly Division
Mount Holly, New Jersey, 08060, United States
RCCA - Pompton Plains Division
Pompton Plains, New Jersey, 07444, United States
RCCA - Sparta Division
Sparta, New Jersey, 07871, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deena Atieh Graham, MD
Hackensack Meridian Health System
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2017
First Posted
March 8, 2017
Study Start
February 28, 2017
Primary Completion
June 13, 2018
Study Completion
June 13, 2018
Last Updated
July 20, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share