The Clinical Relevance of P16 Expressing CTCs Detection Comparing With HPV Infection in Cancer Tissue in HNSCC Patients.

NCT02791607 | Unknown DMC

• 2 other identifiers: CTCHNSCC03CMRPG3E1631-1633
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

HNSCC is the 4th highest incidence of cancer and 6th of cancer death of the males in Taiwan. Because the patients were mainly middle-aged male, the disease eventually resulted in a huge loss of labor force, productivity and a huge burden of family supports and medicinal costs. Currently, the primary treatments of HNSCC are mainly surgery, radiotherapy, chemotherapy or targeted therapy or concurrent chemoradiotherapy. Compared to oral cavity cancer, patients with pharyngeal cancer would possibly harbor HPV infections and have better treatment outcomes, prognosis and survival with clinically significance; however, the investigator's reports showed quite the opposite prognostic value in oral cavity cancer. The inconsistent data urges us to investigate further. Fortunately, in recent years, The investigator have developed a new method for isolation and detection of CTCs in HNSCC patients.The investigator's data found that high level of CTCs in patients with HNSCC and might be associated with disease prognosis, response to treatment and distant metastasis. This novel tool enhances the studies addressing on metastases or recurrence process in HNSCC patients. However, the investigator did not focus whether if the dynamic change of CTCs and specific surface markers on CTCs, such as P16+ CTCs are clinically meaningful. Therefore, in the first year, the investigator will utilize the investigator's developing device and protocol to isolate high-purity CTCs to further identify P16+ on CTCs. In the following 2 years of the project, the investigator will enroll 150 freshly diagnosed patients with oral cavity, oropharyngeal, hypopharyngeal and laryngeal cancer at all stages (75 P16+ and 75 P16- patients) and 30 healthy donors for cell line tests, and then analyze CTCs, background white blood cells signals, and their initial biopsied tissue for P16 positivity test. Further statistical tests with clinical conditions (disease status, treatment effects, progression or distant metastasis and death) will be performed to elucidate their clinical significance.Hopefully, the investigator will clarify the clinical significance of circulating P16 expression status on CTCs by this study and provide a new biomarker for clinical cancer care.

Conditions

Recurrence; Metastasis; Death

Keywords

Circulating tumor cells; Head and neck cancer; Survival Prognosis; P16Ink4A; HPV

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  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.

  one year

Secondary Outcomes (1)

• Overall survival

  one year

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• histologically or cytopathologically proven head and neck squamous cell carcinoma Age ≥ 20 years. Measurable or evaluable disease according to Response Evaluation Criteria In Solid Tumors(RECIST) criteria.
• Ability to sign informed consent.

You may not qualify if:

• Prior cancers within 5 years, except for non-melanoma skin cancers, and in situ cervical cancers.
• Inability to completely with study and/or follow-up procedures.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

Related Publications (3)

• Hsieh JC, Lin HC, Huang CY, Hsu HL, Wu TM, Lee CL, Chen MC, Wang HM, Tseng CP. Prognostic value of circulating tumor cells with podoplanin expression in patients with locally advanced or metastatic head and neck squamous cell carcinoma. Head Neck. 2015 Oct;37(10):1448-55. doi: 10.1002/hed.23779. Epub 2014 Jul 24.

  PMID: 24844673 BACKGROUND

• Huang SB, Wu MH, Lin YH, Hsieh CH, Yang CL, Lin HC, Tseng CP, Lee GB. High-purity and label-free isolation of circulating tumor cells (CTCs) in a microfluidic platform by using optically-induced-dielectrophoretic (ODEP) force. Lab Chip. 2013 Apr 7;13(7):1371-83. doi: 10.1039/c3lc41256c.

  PMID: 23389102 BACKGROUND

• Huang SB, Wang SS, Hsieh CH, Lin YC, Lai CS, Wu MH. An integrated microfluidic cell culture system for high-throughput perfusion three-dimensional cell culture-based assays: effect of cell culture model on the results of chemosensitivity assays. Lab Chip. 2013 Mar 21;13(6):1133-43. doi: 10.1039/c2lc41264k.

  PMID: 23353927 BACKGROUND

Biospecimen

Retention: NONE RETAINED

Blood samples were drawn by standard procedure, stored in EDTA-coating tubes in 4 degree temperature, then sent for CTCs counting and analysis.

MeSH Terms

Conditions

Recurrence; Neoplasm Metastasis; Death; Neoplastic Cells, Circulating; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Neoplasms; Neoplasms by Site

Study Officials

• Chia-Hsun Hsieh, M.D, M.S

  Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Linkou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chang Gung Memorial Hospital

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: June 7, 2016
• Study Start: July 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2019
• Last Updated: August 10, 2017

Record last verified: 2017-08

Locations

TW (1)