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

NCT03192501 | Recruiting DMC FDA Drug

• 1 other identifier: ZZiCAGES-001
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

lung cancer; iCAGES; gene mutation; precision medicine; advanced cancers; IHC; Targeted therapy

Outcome Measures

Primary Outcomes (2)

• PFS

  The PFS will be recorded during the follow up time.

  2 years

• OS

  The OS will be recorded during the follow up time.

  2 years

Secondary Outcomes (2)

• Quality of life.

  2 years

• Pain

  one year

Study Arms (3)

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.

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

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.

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.

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

Interventions

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

Choose appropriate targeted drugs according to NGS/IHC results.

Control group (C group); Study group (A group)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 (90 cases for A group, 70 cases for B group, and 90 cases for C group) are anticipated to be collected. All the patients are more than 18 years old and less than 75 years old. The follow-up will be performed every 2 month until 2 years after the first treatment post-recruitment or quit.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• Sun Yat-sen University: collaborator

Study Sites (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

RECRUITING

Related Publications (1)

• 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 BACKGROUND

Related Links

• test link

Biospecimen

Retention: NONE RETAINED

cancer biopsy samples

MeSH Terms

Conditions

Lung Neoplasms; Neoplasms

Interventions

Erlotinib Hydrochloride; capmatinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Zhenfeng Zhang, MD,PhD

  Second Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenfeng Zhang, MD,PhD

CONTACT

+86-020-34153532; zhangzhf@gzhmu.edu.cn

Deji Chen, MD,PhD

CONTACT

+86-020-34153532; chendeji2003@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 20, 2017
• Study Start: July 1, 2017
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2039
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)