Study Stopped
participants are no longer being examined or treated
Prognostic Value of CTC in HNSCC Patients
CTCHNSCC01
Prognostic Value of Circulating Tumor Cells in Patients With Locally Advanced and Metastatic/Recurrent Head and Neck Cancer
2 other identifiers
observational
53
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 10, 2013
CompletedFirst Posted
Study publicly available on registry
June 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedDecember 10, 2015
February 1, 2013
2.9 years
June 10, 2013
December 9, 2015
Conditions
Keywords
Outcome Measures
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.
one year
Other Outcomes (1)
Overall survival
one year
Eligibility Criteria
Locally advanced or recurrent/metastatic head and neck cancer
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Gung Memorial Hospital
Taoyuan District, 333, Taiwan
Related Publications (1)
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: 24844673DERIVED
Biospecimen
Blood samples were drawn by standard procedure, stored in EDTA-coating tubes in 4 degree temperature, then sent for CTCs counting and analysis.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chia-Hsun C Hsieh, M.D, M.S.
Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Linkou
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
June 10, 2013
First Posted
June 21, 2013
Study Start
June 1, 2012
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
December 10, 2015
Record last verified: 2013-02