Prognostic Value of CTC in HNSCC Patients
Conditions
Recurrence - Metastasis - Death
Conditions: official terms
Neoplastic Cells, Circulating - Recurrence
Conditions: Keywords
Circulating tumor cells, Head and neck cancer, Squamous cell carcinoma, Survival, Prognosis
Study Type
Observational [Patient Registry]
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
Summary
We hypothesized that the number of circulating tumor cells (CTCs) and molecular markers on CTCs could be a prognostic factor or predictive factor to patients with head neck cancer.
Detailed Description
1. Histologically or cytopathologically proven head and neck squamous cell carcinoma (HNSCC)

2. Disease status: locally advanced or recurrent/metastasized at initial presentation

3. Age >=20 years old

4. Could understand and signed the informed consents of this study

5. Enrolled patients were classified into three distinct subgroups:

1. Patients underwent curative surgery followed by adjuvant chemoradiotherapy (CRT) because of some pathologic features such as positive margin, pathologic N2, and extracapsular spread (ECS) of involved lymph nodes indicating early relapse according to recommendation from National Comprehensive Cancer Network(NCCN) guidelines;

2. Patients with advanced disease directly underwent definitive concurrent chemoradiotherapy(CCRT);

3. Patients were to have palliative chemotherapy for existence of distant metastasis or poor general condition for definitive CCRT.

6. Blood samples were collected within 7 days before the first dose of chemotherapy.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
Criteria: Inclusion Criteria:

- 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.

Exclusion Criteria:

- Prior cancers within 5 years, except for non-melanoma skin cancers, and in situ cervical cancers.

Inability to comply with study and/or follow-up procedures.
Location
Chang Gung Memorial Hospital
Taoyuan, Taiwan
Status: Recruiting
Contact: Tsang-Tang Hsieh, M.D - +886-33281200 - sally6869@cgmh.org.tw
Start Date
October 2011
Completion Date
October 2015
Sponsors
Chang Gung Memorial Hospital
Source
Chang Gung Memorial Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page