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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
Sponsor:
Collaborator:
Ministry of Science and Technology, Taiwan
Information provided by (Responsible Party):
Jason Chia-Hsun Hsieh, Chang Gung Memorial Hospital

Tracking Information
First Submitted Date December 21, 2016
First Posted Date December 23, 2016
Last Update Posted Date August 10, 2017
Study Start Date August 2016
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 9, 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.
Original Primary Outcome Measures
 (submitted: December 22, 2016)
Progression-free survival [ Time Frame: one year ]
Measure response or progression events via all available imaging studies, including Chest-Xray, CT scans, or MRI, PET study. The relationship between CTCs number and time from CTCs checkpoint to disease progression will be analyzed.
Change History Complete list of historical versions of study NCT03002350 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 22, 2016)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Relevance of NGS Analysis for High-purity CTC From Cancer Patients With Disruptive Gene Mutation(s)
Official Title Clinical Relevance of Next-generation Sequencing Analysis for High-purity Circulating Tumor Cells From Cancer Patients With Disruptive Gene Mutation(s)
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.
Detailed Description

(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]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Retention:   Samples With DNA
Description:
genomic DNA
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
Condition
  • Recurrence
  • Metastasis
  • Death
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 22, 2016)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2017
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03002350
Other Study ID Numbers CTCNGS001
MOST-105-2314-B-182A-030 - ( Other Identifier: Grantor or Funder MOST-105-2314-B-182A-030 - )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jason Chia-Hsun Hsieh, Chang Gung Memorial Hospital
Study Sponsor Chang Gung Memorial Hospital
Collaborators Ministry of Science and Technology, Taiwan
Investigators
Principal Investigator: Chia-Hsun Hsieh, M.D, M.S Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Linkou
PRS Account Chang Gung Memorial Hospital
Verification Date August 2017