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NCT Number: NCT03192501

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location status: Recruiting

Location contact

Jiexia Zhang, MD,PhD

PRINCIPAL_INVESTIGATOR

Ming Zhao, MD,PhD

PRINCIPAL_INVESTIGATOR

Zhenfeng Zhang, MD,PhD

CONTACT

[email protected]

+86-020-34153532

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

inhibitors, ADC drugs such as tarceva, capmatinib, padcev et al for A/C group.

Drug

Choose appropriate targeted drugs according to NGS/IHC results.

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Deji Chen, MD,PhD

CONTACT

[email protected]

+86-020-34153532

Zhenfeng Zhang, MD,PhD

CONTACT

[email protected]

+86-020-34153532

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Guangzhou Medical University

Other

Collaborators

  • Sun Yat-sen University
  • The First Affiliated Hospital of Guangzhou Medical University

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2030
Study completion
2039
First posted
Jun 20, 2017
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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