Next Generation pErsonalized tX(Therapy) With Plasma DNA Trial-2 in Refractory Solid Tumors (The NEXT-2 Trial)

NCT ID: NCT02140463

Last Updated: 2022-06-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 229 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2019-10-29

Brief Summary

Analysis of cell free DNA(cfDNA), unlike tissue biopsy, presents a new tool for the monitoring and treatment of cancer. The investigators have developed a differentiated sequencing assay, Digital Sequencing Technology (DST) that enables detection of rare genomic abnormalities with ultra high-specificity and sensitivity. The investigators assay is able to eliminate the error and distortion created by sample-prep and sequencing processes in standard NGS(next-generation sequencing ) workflows and produce near-perfect representations of all rare variants.

The investigators have shown that in sequencing a comprehensive cancer panel of 80kbp in 0.1% cancer cell line titration samples, standard Illumina SBS(sequencing by synthesis ) generates many high-quality false positive variant calls in the range of 0.05-5%, while the investigators assay resulted in highly sensitive and completely error-free variant calls across the entire panel.

This work indicates the remarkable potential of using the investigators assay in deep analysis of cfDNA, thereby allowing researchers and clinicians to comprehensively and non-invasively monitor the genetic dimension of cancer throughout the body.

Detailed Description

Same as above

Conditions

Metastatic Gastrointestinal Cancer; Genitourinary Cancer

Study Design

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

Study Groups

metastatic cancer

metastatic gastrointestinal cancer metastatic genitourinary cancer other rare cancer lung cancer

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients older than 20 years
• Patients with histologically confirmed metastatic gastrointestinal cancer, rare cancer, lung cancer
• Patients with histologically confirmed metastatic cancer, who do not have sufficient biopsy material to undergo mutational testing of their tumor, or do not have feasible biopsy sites; melanoma/lung cancer and any solid tumor cancer types will be eligible for the study.
• Written informed consent form

Exclusion Criteria

• Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical condition that would interfere with the subject's safety.
• Double primary cancer (except for any cancer in remission for > 5 years, cervix cancer in situ, basal cell cancer in situ, any in situ cancers that are resected)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jeeyun Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Won Ki Kang, MD

Role: STUDY_CHAIR

Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2013-11-014

Identifier Type: -

Identifier Source: org_study_id