RecurrenceCTCHNSCC01NCT01884129
Prognostic Value of CTC in HNSCC Patients
An observational study of Recurrence and Metastasis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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 more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Recurrence, Metastasis, Death
- How many people
- 53 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2012to May 2015
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Locally advanced or recurrent/metastatic head and neck cancer
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Value of Circulating Tumor Cells in Patients With Locally Advanced and Metastatic/Recurrent Head and Neck Cancer
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
- Histologically or cytopathologically proven head and neck squamous cell carcinoma (HNSCC)
- Disease status: locally advanced or recurrent/metastasized at initial presentation
- Age >=20 years old
- Could understand and signed the informed consents of this study
- Enrolled patients were classified into three distinct subgroups:
- 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;
- Patients with advanced disease directly underwent definitive concurrent chemoradiotherapy(CCRT);
- Patients were to have palliative chemotherapy for existence of distant metastasis or poor general condition for definitive CCRT.
- Blood samples were collected within 7 days before the first dose of chemotherapy.
- Conditions
- Recurrence, Metastasis, Death
- Keywords
- Circulating tumor cells, Head and neck cancer, Squamous cell carcinoma, Survival, Prognosis
- Medical subject headings
- Recurrence, Neoplasm Metastasis, Death, Neoplastic Cells, Circulating, Head and Neck Neoplasms, Carcinoma, Squamous Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startJun 2012
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: participants are no longer being examined or treated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RecurrenceStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Hsun C Hsieh, M.D, M.S., Principal investigator, Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Linkou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884129
- Sponsor's protocol ID
- CTCHNSCC01
- Other IDs
- CMRPG3B0971~3
- Acronym
- CTCHNSCC01
- Status last verified
- Feb 2013
- First submitted
- 10 Jun 2013
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Circulating Tumor Cells in Patients With Locally Advanced and Metastatic/Recurrent Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT01884129
- Acronym / sponsor ID
- CTCHNSCC01 / CTCHNSCC01
- Conditions
- Recurrence, Metastasis, Death
- Keywords
- Circulating tumor cells, Head and neck cancer, Squamous cell carcinoma, Survival, Prognosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: participants are no longer being examined or treated
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Histologically or cytopathologically proven head and neck squamous cell carcinoma (HNSCC)
- Disease status: locally advanced or recurrent/metastasized at initial presentation
- Age >=20 years old
- Could understand and signed the informed consents of this study
- Enrolled patients were classified into three distinct subgroups:
- 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;
- Patients with advanced disease directly underwent definitive concurrent chemoradiotherapy(CCRT);
- Patients were to have palliative chemotherapy for existence of distant metastasis or poor general condition for definitive CCRT.
- Blood samples were collected within 7 days before the first dose of chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Locally advanced or recurrent/metastatic head and neck cancer
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-free survival
Time frame: 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.
Results and safety
The study was stopped early (reason given: participants are no longer being examined or treated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
- Derived from this study: PubMed 24844673Hsieh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Hsun C Hsieh, M.D, M.S. principal investigator
Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Linkou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrence and Metastasis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: participants are no longer being examined or treated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01884129, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2015.