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

NCT ID: NCT03917524

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-01
• Study Completion Date: 2020-07-31

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.

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

Conditions

Oral Cavity Squamous Cell Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

no need for any adjuvant therapy

Patients with oral cavity squamous cell carcinoma post-surgery no need for any adjuvant therapy

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chun-Ta Liao, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Otolaryngology, Chang Gung Memorial Hospital at Linkou

Locations

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Facility Contacts

Yo-Ting Hsueh

Role: primary

sally6869@cgmh.org.tw

03-3196200 ext. 3703

Chia-Hsun Hsieh, M.D,M.S.

Role: backup

wisdom5000@gmail.com

+886-33281200 ext. 8825

Other Identifiers

MOST104-2314-B-182A-073-MY3

Identifier Type: OTHER

Identifier Source: secondary_id

CTCNGS002

Identifier Type: -

Identifier Source: org_study_id