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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
Sponsor:
Collaborators:
The First Affiliated Hospital of Guangzhou Medical University
Sun Yat-sen University
Information provided by (Responsible Party):
Second Affiliated Hospital of Guangzhou Medical University

Brief Summary:
This study prospectively evaluates whether the use of iCAGES (integrated CAncer GEnome Score) tool in guiding the treatment of advanced cancers is superior to current standard care in progress free survival (PFS),overall survival (OS),and improvement of life quality.

Condition or disease
Lung Cancer Gene Abnormality Gene Product Sequence Variation Cancer

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. PFS [ Time Frame: 2 years ]
    The PFS will be recorded during the follow up time.

  2. OS [ Time Frame: 2 years ]
    The OS will be recorded during the follow up time.


Secondary Outcome Measures :
  1. Quality of life. [ Time Frame: 2 years ]
    Physicians Global Assessment to measure quality of life

  2. Pain [ Time Frame: one year ]
    Visual Analog Score for pain


Biospecimen Retention:   Samples With DNA
cancer biopsy samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
In this study, all the patients will be recruited from the Second Affiliated Hospital of Guangzhou Medical University and the collaborated Hospitals during 01/07/2017 to 01/07/2019, 250 advanced patients (180 cases for A group and 70 cases for B group) are anticipated to be collected. All the patients are more than 18 years old and less than 70 years old. The follow-up will be performed every 2 month until 2 years after the first treatment post-recruitment or quit.
Criteria

Inclusion Criteria:

  • Pathological and clinical diagnosis of recurrence / metastatic lung cancer or other advanced cancers.
  • There are PACS images available at the Second Affiliated Hospital of Guangzhou Medical University and the collaborated Hospitals.
  • The patient is informed consent and signed a written consent.

Exclusion Criteria:

  • Age > 70 or <18 years old.
  • Previous history of malignant tumors.
  • Pregnant or lactating female patients.
  • Any serious concomitant disease that is expected to have an adverse effect on prognosis, including the heart disease that treatment is required, unsatisfactory controlled diabetes and psychiatric disorders.

Information from the National Library of Medicine

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


Contacts
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Contact: Zhenfeng Zhang, MD,PhD +86-020-34153532 zhangzhf@gzhmu.edu.cn
Contact: Deji Chen, MD,PhD +86-020-34153532 chendeji2003@163.com

Locations
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China, Guangdong
The Second Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510260
Contact: Zhenfeng Zhang, MD,PhD    +86-020-34153532    zhangzhf@gzhmu.edu.cn   
Principal Investigator: Jiexia Zhang, MD,PhD         
Principal Investigator: Ming Zhao, MD,PhD         
Sponsors and Collaborators
Second Affiliated Hospital of Guangzhou Medical University
The First Affiliated Hospital of Guangzhou Medical University
Sun Yat-sen University
Investigators
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Principal Investigator: Zhenfeng Zhang, MD,PhD Second Affiliated Hospital of Guangzhou Medical University

Additional Information:
Publications:
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Responsible Party: Second Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT03192501     History of Changes
Other Study ID Numbers: iCAGES on cancer therapy
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Second Affiliated Hospital of Guangzhou Medical University:
lung cancer
iCAGES
gene mutation
precision medicine
advanced cancers

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases