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
|Condition or disease|
|Oral Cavity Squamous Cell Carcinoma|
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
Clinical Trial, Patient Enrollment and Design of Schedule
The Inclusion criteria and aims are as followings:
- 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.
- 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
- Testing: Circulating tumor cells (CTCs) (x4) and NGS for WGA and transcriptomes (x4)
- Endpoints: Loco-regional recurrence, one-year distant metastasis rate, death, second primary tumor occurrence.
- 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.
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.
- Negative Selection Method
- Positive Selection method (Dynabeads)
- ODEP devices
- Flow Cytometry and Sorting System
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||180 participants|
|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|
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
- 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): NCT03917524
|Chang Gung Memorial Hospital||Recruiting|
|Taoyuan, Taiwan, 333|
|Contact: Yo-Ting Hsueh 03-3196200 ext 3703 email@example.com|
|Contact: Chia-Hsun Hsieh, M.D,M.S. +886-33281200 ext 8825 firstname.lastname@example.org|
|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|
|Principal Investigator:||Chun-Ta Liao, MD||Division of Otolaryngology, Chang Gung Memorial Hospital at Linkou|