The Clinical Relevance of Immune Cells and CTC in HNSCC Patients

NCT02420600 | Unknown DMC

• 2 other identifiers: CTCHNSCC02CMRPG3E0511-0512
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Head and neck squamous cell carcinomas (HNSCCs) are mainly caused by tobacco, alcohol consumption and betel nut chewing and the sixth most common cancer in the world. Despite significant advances in the treatment modalities involving surgery, radiotherapy, and concomitant chemoradiotherapy, the 5-year survival rate remained below 50% for the past 30 years. The worse prognosis of these cancers must certainly be linked to the fact that HNSCCs strongly influence the host immune system. During this process, mesenchymal tumor-like cells are highly mobile and enter quickly adjacent structure (intravasation), from where they travel through lymphatic and blood vessels as circulating tumor cells (CTC), which are single cells with malignant potential detected in the peripheral bloodstream and essential for establishing metastasis. Programmed death 1 (PD-1) and its ligand (PD-L1) play pivotal roles in regulating host immune responses. Substantial evidence has demonstrated that PD-L1 can deliver an inhibitory signal to PD-1 expressing T cells, leading to suppression of the immune response by inducing apoptosis, energy, unresponsiveness and functional exhaustion of T cells. However, the inhibitory effects of this pathway on the function of cytotoxic T lymphocytes, the main effector cells in HNSCC patients, are not well defined. In this study aims to solve two main problems: one is to improve and try to optimize current protocols of CTC isolations based on the investigator previous work, which is one of most challenging problems in CTC field to date; the other is to understand the status of immune system in HNSCC patients, especially focusing on PD-1-PD-L1 pathway and its expressions. After series basic experiments of immune cell analysis and conditional adjustment of CTC isolation protocols, the investigator are willing to isolate CTCs and immune cells at a single blood drawing at the same time. A prospective trial will be conducted to elucidate the roles of PD-1 expression lymphocytes and CTC numbers on the clinical outcomes of HNSCC patients.

Conditions

Recurrence; Metastasis; Death

Keywords

Circulating tumor cells; Head and neck cancer; PD-1; natural killer cells; cytotoxic T lymphocytes

Outcome Measures

Primary Outcomes (1)

• The correlation among CTC numbers, PD-1 expressions and the prognosis of patients.

  The CTCs will be isolated and then the number of CTCs will be measured. PD-1 expression from locally advanced or metastatic HNSCC patients will be validated. Measure response or progression events via all available imaging studies, including Chest-Xray, CT scans, or MRI, PET study. The relationship between CTCs number, PD1 expression 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

Locally advanced or recurrent/metastatic head and neck cancer

You may qualify if:

• Established head and neck squamous cell carcinoma.
• Age \>=20 years old with clear consciousness, decided by free wills.
• Ability to sign informed consent

You may not qualify if:

• Patient's refusal
• Poor compliance, cannot draw blood for CTCs isolation as time schedule or clinical treatment or follow-up
• Difficult blood sampling
• No more needs for CTCs evaluation, decided by clinicians.
• Inability to comply 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 (2)

• 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 RESULT

• Chang PH, Wu MH, Liu SY, Wang HM, Huang WK, Liao CT, Yen TC, Ng SH, Chen JS, Lin YC, Lin HC, Hsieh JC. The Prognostic Roles of Pretreatment Circulating Tumor Cells, Circulating Cancer Stem-Like Cells, and Programmed Cell Death-1 Expression on Peripheral Lymphocytes in Patients with Initially Unresectable, Recurrent or Metastatic Head and Neck Cancer: An Exploratory Study of Three Biomarkers in One-time Blood Drawing. Cancers (Basel). 2019 Apr 15;11(4):540. doi: 10.3390/cancers11040540.

  PMID: 30991692 DERIVED

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 Lingkou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: April 20, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: August 16, 2017

Record last verified: 2017-04

Locations

TW (1)