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Feasibility of CTCs Isolation for Transcriptomes and Genome Wide Associated Analysis in Post-OP High Risk OSCC Patients. (CTC)

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ClinicalTrials.gov Identifier: NCT03917524
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
Ministry of Science and Technology, Taiwan
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:
Anti-cancer treatments have been thought to be closely related to their unique genetic alterations. In the past few years, the investigator have used cDNA microarray to delineate the transcriptome profiles of differentially-expressed genes between OSCC tumors and normal epithelium. By supervised hierarachical clustering analysis, the investigator further analyzed and validated the differentially-expressed genes for OSCC tumors. In the investigators' previous research, the investigators have used this strategy to analyze the potential tissue proteins associated with OSCC tumors, indicating the feasibility of this strategy. However, gene detection is a great limitation and challenge in CTCs researches owing to the small number of isolated cells by traditional methods. Fortunately, by means of the investigators' developing high-purity CTCs isolation techniques, some preliminary data implied that isolated CTCs by this method could achieve the criteria of Whole-genome analysis (WGA), which brings the investigators' passion for further investigation.

Condition or disease
Oral Cavity Squamous Cell Carcinoma

Detailed Description:

First Year

1. Negative Selection Method 2. Positive Selection method (Dynabeads) 3. ODEP devices 4. Flow Cytometry and Sorting System 5. Cell lines for Positive control Second Year &Third year

  1. Clinical Trial, Patient Enrollment and Design of Schedule

    The Inclusion criteria and aims are as followings:

    1. Patients with oral cavity squamous cell carcinoma (n=180), with age at diagnosis ≥ 20 years, will be enrolled before surgery at Ear-Nose-Throat department inpatient or outpatient service by Dr. Liao, Dr. Hsieh, Dr. Wang and co-PIs.
    2. All patients will be subgrouped by pathologic features and risk factors Group A (n=90): OSCC, post-surgery, no need for any adjuvant therapy Group B (n=90): OSCC, post-surgery, with major risk factor(s) or 2 minor risk factors Stratification by Risk factors, alcohol, betel nut chewing and cigarette use status
    3. Testing: Circulating tumor cells (CTCs) (x4) and NGS for WGA and transcriptomes (x4)
    4. Endpoints: Loco-regional recurrence, one-year distant metastasis rate, death, second primary tumor occurrence.
    5. Exclusion criteria are: (1) Patient's refusal; (2) Poor compliance, cannot cooperate for blood sampling for CTCs isolation as time schedule or clinical treatment or follow-up (3) Difficult blood sampling; (4) No more needs for CTCs evaluation, decided by clinicians.
  2. Whole-Genome Analysis for Cancer Tissue Samples/Circulating Tumor Cells When needed, OncoScan™ FFPE Express Extraction will be performed

    Requirements need to be observed when submitting FFPE slices:

    Slices should be sent in 1.5mL conical vials Tumor samples in sections should have a surface area of 100 square mm (Minimum) to 1000 square mm (Maximum).

    Normal samples in sections should have a surface area of 200 square mm (Minimum) to 1000 square mm (Maximum).

    Section thickness should be 10 micron. The range of sections acceptable per sample is 2-6. Slices for OncoScan analysis and immunohistochemistry study are separated; and will be doubly charged by the Dep. of Clinical Pathology.

    The QIAamp DNA FFPE Tissue Kit is optimized for purification of DNA from FFPE tissue sections.

    OncoScan™ Express Samples will be performed in Chang Gung Memorial Hospital 1J GMRCL CoreLab or Chang Gung University Labs for whole-genome analysis.

  3. Negative Selection Method
  4. Positive Selection method (Dynabeads)
  5. ODEP devices
  6. Flow Cytometry and Sorting System

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: The Feasibility of Circulating Tumor Cells Isolation for Transcriptomes and Genome-wide Associated Analysis in Post-surgically High-risk Oral Cavity Cancer Patients and Its Clinical Significance.
Actual Study Start Date : August 1, 2015
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
no need for any adjuvant therapy
Patients with oral cavity squamous cell carcinoma post-surgery no need for any adjuvant therapy
with risk factors
Patients with oral cavity squamous cell carcinoma post-surgery with major risk factor(s) or 2 minor risk factors Stratification by Risk factors, alcohol, betel nut chewing and cigarette use status



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
Blood


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
Sampling Method:   Non-Probability Sample
Study Population
Patients with oral cavity squamous cell carcinoma
Criteria

Inclusion Criteria:

  • Patients with oral cavity squamous cell carcinoma (n=180), with age at diagnosis ≥ 20 years, will be enrolled before surgery at Ear-Nose-Throat department inpatient or outpatient service by Dr. Liao, Dr. Hsieh, Dr. Wang and co-PIs.

Exclusion Criteria:

  • (1) Patient's refusal; (2) Poor compliance, cannot cooperate for blood sampling for CTCs isolation as time schedule or clinical treatment or follow-up (3) Difficult blood sampling; (4) No more needs for CTCs evaluation, decided by clinicians.

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 ClinicalTrials.gov identifier (NCT number): NCT03917524


Locations
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Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: Yo-Ting Hsueh    03-3196200 ext 3703    sally6869@cgmh.org.tw   
Contact: Chia-Hsun Hsieh, M.D,M.S.    +886-33281200 ext 8825    wisdom5000@gmail.com   
Sub-Investigator: Chia-Hsun Hsieh, M.D, M.S         
Principal Investigator: Chun-Ta Liao, M.D         
Sub-Investigator: Hung-Ming Wang, M.D         
Sub-Investigator: Chien-Yu Lin, M.D         
Sub-Investigator: Tzu-Chen Yen, M.D         
Sub-Investigator: Li-Yu Lee, M.D         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Ministry of Science and Technology, Taiwan
Investigators
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Principal Investigator: Chun-Ta Liao, MD Division of Otolaryngology, Chang Gung Memorial Hospital at Linkou

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03917524     History of Changes
Other Study ID Numbers: CTCNGS002
MOST104-2314-B-182A-073-MY3 ( Other Identifier: Grantor or Funder MOST104-2314-B-182A-073-MY3 )
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chang Gung Memorial Hospital:
Oral Cavity Cancer
Circulating Tumor Cells
Whole-genome analysis
transcriptomes
distant metastasis
locoregional recurrence
second primary tumor

Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Neoplastic Cells, Circulating
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes