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

NCT02140463 | Completed

• 1 other identifier: 2013-11-014
• Study Type: observational
• Target: 229
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Gastrointestinal Cancer; Genitourinary Cancer

Outcome Measures

Primary Outcomes (1)

• feasibility

  The feasibility of the use of plasma cell free DNA - molecular profiling to direct targeted therapies in the treatment of refractory solid tumors -ANALYSIS : The analysis of this exploratory study will be primarily descriptive. Data will be presented by means of summary statistics tables, graphs and listings.

  From date of start of targeted treatment oriented by NEXT until the date of first progression or date of death from any cause, whichever came first, assessed up to 1 year ]

Secondary Outcomes (6)

• progression free survival (PFS),

  1years

• molecular profile with cell-free DNA

  From date of start of targeted treatment oriented by NEXT until the date of first progression or date of death from any cause, whichever came first, assessed up to 1 year ]

• serial cfDNA samples

  From date of start of targeted treatment oriented by NEXT until the date of first progression or date of death from any cause, whichever came first, assessed up to 1 year ]

• Duration of response

  1years

• overall survival

  1years

Study Arms (1)

metastatic cancer

metastatic gastrointestinal cancer metastatic genitourinary cancer other rare cancer lung cancer

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

pathologically confirmed cancer patient

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 99999, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

circulating free DNA

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Urogenital Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Won Ki Kang, MD

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: May 16, 2014
• Study Start: February 1, 2014
• Primary Completion: July 1, 2019
• Study Completion: October 29, 2019
• Last Updated: June 15, 2022

Record last verified: 2022-06

Locations

KR (1)