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

NCT ID: NCT03192501

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2039-07-01

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 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.

Conditions

Lung Cancer; Gene Abnormality; Gene Product Sequence Variation; Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

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

Intervention Type: DRUG

Choose appropriate targeted drugs according to NGS/IHC results.

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.

No interventions assigned to this group

Control group (C group)

In this group, patients with advanced cancers (matched with Group A) will be treated with appropriate targeted drugs according to IHC detection of more than 20 protein molecules with blank tissue slides from the cancer.

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

Intervention Type: DRUG

Choose appropriate targeted drugs according to NGS/IHC results.

Interventions

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

Choose appropriate targeted drugs according to NGS/IHC results.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhenfeng Zhang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Guangzhou Medical University

Locations

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhenfeng Zhang, MD,PhD

Role: CONTACT

zhangzhf@gzhmu.edu.cn

+86-020-34153532

Deji Chen, MD,PhD

Role: CONTACT

chendeji2003@163.com

+86-020-34153532

Facility Contacts

Zhenfeng Zhang, MD,PhD

Role: primary

zhangzhf@gzhmu.edu.cn

+86-020-34153532

References

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.

Reference Type: BACKGROUND

PMID: 28007024 (View on PubMed)

Related Links

http://nih.gov

test link

Other Identifiers

ZZiCAGES-001

Identifier Type: -

Identifier Source: org_study_id