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TerminatedNCT01884129CTCHNSCC01Updated Dec 10, 2015

Prognostic Value of CTC in HNSCC Patients

An observational study in Recurrence, Metastasis and Death, sponsored by Chang Gung Memorial Hospital. Terminated at 1 site in Taiwan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-10.

Sponsored by Chang Gung Memorial Hospital · Observational

Why this study was terminated
participants are no longer being examined or treated
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
53
Ages
20 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Recurrence
  • Metastasis
  • Death

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Keywords

  • Circulating tumor cells
  • Head and neck cancer
  • Squamous cell carcinoma
  • Survival
  • Prognosis
03

In context

Recurrence

4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.

This study's enrollment of 53 is below the median of 200 across 702 observational studies indexed under Recurrence.

Browse Recurrence studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Locally advanced or recurrent/metastatic head and neck cancer

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

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
53 participants (actual)
Target follow-up
12 Months
Patient registry
Yes
Biospecimen retention
None retained
06

What researchers measure

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.

    Time frame: one year

Other outcomes

  1. Overall survival

    All causes of death would be documented and the relationship between CTCs number and time from CTCs checkpoint to death will be analyzed.

    Time frame: one year

07

Study locations

1 site
  • Chang Gung Memorial Hospital
    Taoyuan, 333, Taiwan
08

References and documents

Publications

  • 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. PubMed 24844673 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01884129
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
Jun 21, 2013
Start date
Jun 2012
Primary completion
May 2015
Completion
May 2015
Last update
Dec 10, 2015

Study contacts

Chia-Hsun C Hsieh, M.D, M.S.
principal investigator · Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Linkou

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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