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Recruiting NCT03192501

iCAGES-guided Precision Therapy for Cancers in Contrast to Standard Care or IHC-guided Theray

— Observational Lung Cancer Gene Abnormality Gene Product Sequence Variation Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: inhibitors, ADC drugs such as tarceva, capmatinib, padcev et al for A/C group..
Who it may be relevant to
Registry conditions: Lung Cancer, Gene Abnormality, Gene Product Sequence Variation, Cancer. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Multicentre Perspective Non-interventional Study of Survival Benefits of iCAGES-guided Therapy in Contrast to Standard Therapy or IHC-guided Therapy for Advanced Cancers

Overview

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 or IHC-guided therapy in progress free survival (PFS),overall survival (OS),and improvement of life quality.

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.

IHC detection of multiple molecules such as EGFR, HER2-3, TROP3, NECTIN4, MET, B7-H3-4, B1-H7, Claudin18.2, FGFR1-4, Mesothelin, ROR1, BCMA, AXL, TF, FRα, CD70, PPARα, HIF-2α, RET, ROS1, NTRK, CDK4/6, FLT3, EZH2 are also scheduled for appropriate targeted therapy and comparison if available.

Interventions

  • Drug inhibitors, ADC drugs such as tarceva, capmatinib, padcev et al for A/C group.
    Choose appropriate targeted drugs according to NGS/IHC results.

Primary outcome measures

  • PFS [Time frame: 2 years]
  • OS [Time frame: 2 years]
Secondary outcome measures (2)
  • Quality of life. [Time frame: 2 years]
  • Pain [Time frame: one year]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

China · 1 center
  • The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou

Publications

  • Dong C, Guo Y, Yang H, He Z, Liu X, Wang K. iCAGES: integrated CAncer GEnome Score for comprehensively prioritizing driver genes in personal cancer genomes. Genome Med. 2016 Dec 22;8(1):135. doi: 10.1186/s13073-016-0390-0. PMID 28007024

Identifiers

NCT: NCT03192501 · ZZiCAGES-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗