Prognostic Value of CTC in HNSCC Patients

Prognostic Value of Circulating Tumor Cells in Patients With Locally Advanced and Metastatic/Recurrent Head and Neck Cancer

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01884129

Acronym

CTCHNSCC01

Enrollment

Registered

2013-06-21

Start date

2012-06-30

Completion date

2015-05-31

Last updated

2015-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Death, Metastasis, Recurrence

Keywords

Circulating tumor cells, Head and neck cancer, Squamous cell carcinoma, Survival, Prognosis

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Progression-free survival	one year	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.

Other

Measure	Time frame	Description
Overall survival	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.

Countries

Taiwan

Outcome results