iCAGES-guided Precision Therapy for Cancers in Contrast to Standard Care
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|ClinicalTrials.gov Identifier: NCT03192501|
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : November 2, 2018
|Condition or disease|
|Lung Cancer Gene Abnormality Gene Product Sequence Variation Cancer|
Cancer is a fatal disease caused by the accumulation of various oncogene and tumor suppressor gene mutations. Studies of high-throughput sequencing for patients who suffered from cancer has found that different mutations play a different role in the occurrence and development of different cancers. Several gene panels already exist to help identify mutations in a few genes that may have corresponding FDA-approved drugs or drugs under clinical trials. However, given whole-genome/exome sequencing data, the suitable clinical analysis tool to analyze individualized cancer-related gene mutations, and recommend the most appropriate targeted treatment options among hundreds of possible drugs therapy is absent currently.
The recently proposed iCAGES is a precise biomedical informatics analysis tool, which could help increase the accuracy of cancer driver gene detection and prioritization, bridge the gap between personal cancer genomic data and prior cancer research knowledge,and facilitate cancer molecular diagnosis as well as personalized precision therapy.
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Multicentre Perspective Non-interventional Study of Survival Benefits of iCAGES-guided Therapy in Contrast to Standard Therapy for Advanced Cancers|
|Actual Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||July 1, 2020|
|Estimated Study Completion Date :||July 1, 2021|
Study group (A group)
In this group, we perform whole exome or genome sequencing of tumor sample in compared to blood sample, screen tumor-related special mutations by using biomedical informatics analysis procedure and utilized the iCAGES system to rank the most appropriate drugs available and then manually examine this list to select the best therapeutic strategy for the patient based on availability of drug and expert knowledge. The PFS, OS, and quality of life (QOL) will be recorded and compared with that from standard care.
Control group (B group)
In this group, patients with advanced cancers (matched with Group A) will be treated under the guidance of NCCN, without performing iCAGES analysis.
- PFS [ Time Frame: 2 years ]The PFS will be recorded during the follow up time.
- OS [ Time Frame: 2 years ]The OS will be recorded during the follow up time.
- Quality of life. [ Time Frame: 2 years ]Physicians Global Assessment to measure quality of life
- Pain [ Time Frame: one year ]Visual Analog Score for pain
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192501
|Contact: Zhenfeng Zhang, MD,PhDfirstname.lastname@example.org|
|Contact: Deji Chen, MD,PhDemail@example.com|
|The Second Affiliated Hospital of Guangzhou Medical University||Recruiting|
|Guangzhou, Guangdong, China, 510260|
|Contact: Zhenfeng Zhang, MD,PhD +86-020-34153532 firstname.lastname@example.org|
|Principal Investigator: Jiexia Zhang, MD,PhD|
|Principal Investigator: Ming Zhao, MD,PhD|
|Principal Investigator:||Zhenfeng Zhang, MD,PhD||Second Affiliated Hospital of Guangzhou Medical University|