Prognostic Value of CTC in HNSCC Patients

NCT ID: NCT01884129

Last Updated: 2015-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-05-31

Brief Summary

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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

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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.

Conditions

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Recurrence Metastasis Death

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 24844673 (View on PubMed)

Other Identifiers

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CMRPG3B0971~3

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CTCHNSCC01

Identifier Type: -

Identifier Source: org_study_id