Clinical Relevance of NGS Analysis for High-purity CTC From Cancer Patients With Disruptive Gene Mutation(s)
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|ClinicalTrials.gov Identifier: NCT03002350|
Recruitment Status : Recruiting
First Posted : December 23, 2016
Last Update Posted : August 10, 2017
|Condition or disease|
|Recurrence Metastasis Death|
(A) Establish a High-purity isolation of CTCs to NGS platform within one year
(B) Design a Prospective trial (CTCNGS01 at www.clinicaltrials.gov) utilizing the developed technique to elucidate the baseline CTC-NGS information to cancer tissue NGS.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||40 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||Clinical Relevance of Next-generation Sequencing Analysis for High-purity Circulating Tumor Cells From Cancer Patients With Disruptive Gene Mutation(s)|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||November 2017|
- Progression-free survival [ Time Frame: one year ]Measure response or progression events via all available imaging studies, including Chest-Xray, CT scans, or MRI, Positron Emission Tomography(PET)study. The relationship between CTCs number and time from CTCs checkpoint to disease progression will be analyzed.
- Overall survival [ Time Frame: one year ]All causes of death would be documented and the relationship between CTCs number and time from CTCs checkpoint to death will be analyzed.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03002350
|Chang Gung Memorial Hospital||Recruiting|
|Taoyuan, Taiwan, 333|
|Contact: Yo-Ting Hsueh 03-3196200 ext 3703 firstname.lastname@example.org|
|Contact: Chia-Hsun Hsieh, M.D,M.S. +886-33281200 ext 8825 email@example.com|
|Principal Investigator: Chia-Hsun Hsieh, M.D, M.S|
|Sub-Investigator: Min-Hsien Wu, Ph.D|
|Sub-Investigator: Hung-Ming Wang, M.D|
|Sub-Investigator: Yung-Chang Lin, M.D|
|Sub-Investigator: Tzu-Chen Yen, M.D|
|Sub-Investigator: Hung-Chih Hsu, M.D|
|Principal Investigator:||Chia-Hsun Hsieh, M.D, M.S||Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Linkou|