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Clinical Relevance of NGS Analysis for High-purity CTC From Cancer Patients With Disruptive Gene Mutation(s)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03002350
Recruitment Status : Recruiting
First Posted : December 23, 2016
Last Update Posted : August 10, 2017
Ministry of Science and Technology, Taiwan
Information provided by (Responsible Party):
Jason Chia-Hsun Hsieh, Chang Gung Memorial Hospital

Brief Summary:
Distant metastasis of cancer remains the major cause of cancer death. One of the evidence is that some rare cells shed from primary tumor exist in the circulation of cancer patients, which has been proven to be related to cancer relapse and distant metastasis. The number of circulating tumor cells (CTCs) or the expression status of specific marker(s) on them also correlated with the disease prognosis and treatment effects, which might change the decision of treatments. In recent years, as specific disruptive genes were discovered, such as epidermal growth factor receptor (EGFR) in non-small cell lung cancer,Kirsten rat sarcoma (KRAS) in colorectal cancer, the response rate to treatment, disease control and survival have been much improved. However, the molecular information obtained from cancer tissue depends on repeated biopsies, which is very risky and invasive to cancer patients. By means of the advances of CTCs sampling technique with genetic analysis, repeated follow-up for specific gene profiles is possible. However, the protocol has not been well-established and mature, even the correlation between primary cancer tissue and CTCs remains unknown. To tackle the problems above, the aims of the project is to isolate high-purity CTCs by the optically induced dielectrophoresis (ODEP)-based device or other cell sorting techniques and transfer to next-generation sequencing (NGS) analysis for specific disruptive genes. In the first year of the project, the investigator will testify and stabilize the platform utilizing healthy donors' blood and cancer cell lines and adjust the detailed experiment conditions. In the following year, the investigator will enroll newly diagnosed metastatic cancer patients with the disruptive gene mutation(s) and follow up the events under gene-based therapy. Comparison of NGS information between cancer tissue and CTCs will be also made as one of the major endpoints. In brief, the investigator expect the study could establish a practical method to get genetic information, to reduce the risk of re-biopsy and to achieve the ultimate goal of precision medicine.

Condition or disease
Recurrence Metastasis Death

Detailed Description:

(A) Establish a High-purity isolation of CTCs to NGS platform within one year

(B) Design a Prospective trial (CTCNGS01 at utilizing the developed technique to elucidate the baseline CTC-NGS information to cancer tissue NGS.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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
genomic DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study will be conducted in three branch hospitals of Chang Gung Memorial Hospital, Taiwan including Keelung, Linkou, Taipei. Locally advanced or recurrent/metastatic head and neck cancer

Inclusion Criteria:

I. Age at diagnosis ≥ 20 years, II. Can fully understand the purpose of the study, pros/cons of entering the trial with clear and free mind III. With acceptable laboratory data for receiving anti-cancer therapy, adjusted by clinicians.

IV. Accept all the protocol procedures, including blood sampling and cancer tissue retrieve.

Exclusion Criteria:

I. Refuse to any of study protocol or procedure(s) at any time before or during the trial.

II. Patients without actionable gene alteration or mutation(s) in tissue at screening phase III. Patients who cannot tolerate anti-cancer therapy for at least 2 months should be withdrawn IV. Patients who cannot cooperate the imaging study for response evaluation of anti-cancer therapy V. Patients' tissue is too small to retrieve for NGS analysis. VI. Difficult blood sampling. VII. Clinician's judgement.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03002350

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Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: Yo-Ting Hsueh    03-3196200 ext 3703   
Contact: Chia-Hsun Hsieh, M.D,M.S.    +886-33281200 ext 8825   
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         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Ministry of Science and Technology, Taiwan
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Principal Investigator: Chia-Hsun Hsieh, M.D, M.S Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Linkou

Additional Information:

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Responsible Party: Jason Chia-Hsun Hsieh, Director,Hematology&Oncology, Principal Investigator, Chang Gung Memorial Hospital Identifier: NCT03002350     History of Changes
Other Study ID Numbers: CTCNGS001
MOST-105-2314-B-182A-030 - ( Other Identifier: Grantor or Funder MOST-105-2314-B-182A-030 - )
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017

Keywords provided by Jason Chia-Hsun Hsieh, Chang Gung Memorial Hospital:
Circulating tumor cells (CTCs)
Optically induced dielectrophoresis (ODEP)
Cell sorting
Next-generation sequencing (NGS)
disruptive mutation

Additional relevant MeSH terms:
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Neoplastic Cells, Circulating
Disease Attributes
Pathologic Processes
Neoplasm Metastasis
Neoplastic Processes