AzTrials
AzTrials

RecurrenceNCT02791607

The Clinical Relevance of P16 Expressing CTCs Detection Comparing With HPV Infection in Cancer Tissue in HNSCC Patients.

An observational study of Recurrence and Metastasis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

HNSCC is the 4th highest incidence of cancer and 6th of cancer death of the males in Taiwan. Because the patients were mainly middle-aged male, the disease eventually resulted in a huge loss of labor force, productivity and a huge burden of family supports and medicinal costs. 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
150 participants
Where
1 siteTaiwan
Study dates
Jul 2015to Jun 2019
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: The study will be conducted in three branch hospitals of Chang Gung Memorial Hospital, Taiwan including Keelung, Linkou, Taipei. 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 completely with study and/or follow-up procedures.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting

  • Chang Gung Memorial Hospital

    Taoyuan, 333

    Tsang-Tang Hsieh, M.D, +886-33281200 ext. 8825, sally6869@cgmh.org.tw

    Chia-Hsun Hsieh, M.D,M.S., +886-33281200 ext. 8825, wisdom5000@gmail.com

    Recruiting

Other trials in Taiwan

About this study

Official title: Technical Development of P16-INk4A-expressing Circulating Tumor Cells Detection Comparing With Human Papillomavirus Infection in Cancer Tissue in Patients With Head and Neck Cancer and Its Clinical Relevance.

HNSCC is the 4th highest incidence of cancer and 6th of cancer death of the males in Taiwan. Because the patients were mainly middle-aged male, the disease eventually resulted in a huge loss of labor force, productivity and a huge burden of family supports and medicinal costs. Currently, the primary treatments of HNSCC are mainly surgery, radiotherapy, chemotherapy or targeted therapy or concurrent chemoradiotherapy. Compared to oral cavity cancer, patients with pharyngeal cancer would possibly harbor HPV infections and have better treatment outcomes, prognosis and survival with clinically significance; however, the investigator's reports showed quite the opposite prognostic value in oral cavity cancer. The inconsistent data urges us to investigate further. Fortunately, in recent years, The investigator have developed a new method for isolation and detection of CTCs in HNSCC patients.The investigator's data found that high level of CTCs in patients with HNSCC and might be associated with disease prognosis, response to treatment and distant metastasis. This novel tool enhances the studies addressing on metastases or recurrence process in HNSCC patients. However, the investigator did not focus whether if the dynamic change of CTCs and specific surface markers on CTCs, such as P16+ CTCs are clinically meaningful.

Therefore, in the first year, the investigator will utilize the investigator's developing device and protocol to isolate high-purity CTCs to further identify P16+ on CTCs. In the following 2 years of the project, the investigator will enroll 150 freshly diagnosed patients with oral cavity, oropharyngeal, hypopharyngeal and laryngeal cancer at all stages (75 P16+ and 75 P16- patients) and 30 healthy donors for cell line tests, and then analyze CTCs, background white blood cells signals, and their initial biopsied tissue for P16 positivity test. Further statistical tests with clinical conditions (disease status, treatment effects, progression or distant metastasis and death) will be performed to elucidate their clinical significance.Hopefully, the investigator will clarify the clinical significance of circulating P16 expression status on CTCs by this study and provide a new biomarker for clinical cancer care.

Read the detailed description
  1. Establish a protocol and a practical platform to longitudinally isolate, enumerate CTCs in patients with HPV+-head and neck cancer during the treatment course.
  2. Elucidate the clinical significance of P16 INK4A -expressing CTCs to cancer status and treatment response.
  3. Verify that dynamically monitoring P16 status and changes during anti-cancer treatment is feasible and clinically meaningful to survival or treatment responses.
  4. Analyze different habitual conditions, i.e. alcohol, cigarette and betel nut use to P16-expressing CTCs.
  5. Establish a good model to follow-up a specific surface marker on CTCs, which could be possibly utilized in other cancers with their particular markers (i.e. CEA on gastric cancer, Her2 on breast cancer)
Keywords
Circulating tumor cells, Head and neck cancer, Survival Prognosis, P16Ink4A, HPV
Medical subject headings
Recurrence, Neoplasm Metastasis, Death, Neoplastic Cells, Circulating, Head and Neck Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: one year

Secondary outcomes (1)

  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.

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2016 (estimated)
  2. Study startJul 2015
  3. Primary completionJun 2018 (estimated)
  4. Study completionJun 2019 (estimated)

Resources

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
150 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02791607
Sponsor's protocol ID
CTCHNSCC03
Other IDs
CMRPG3E1631-1633
Status last verified
Aug 2017
First submitted
1 Jun 2016
Last updated
10 Aug 2017
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

  • Huang SB, Wu MH, Lin YH, Hsieh CH, Yang CL, Lin HC, Tseng CP, Lee GB. High-purity and label-free isolation of circulating tumor cells (CTCs) in a microfluidic platform by using optically-induced-dielectrophoretic (ODEP) force. Lab Chip. 2013 Apr 7;13(7):1371-83. doi: 10.1039/c3lc41256c.

    PubMed 23389102

  • Huang SB, Wang SS, Hsieh CH, Lin YC, Lai CS, Wu MH. An integrated microfluidic cell culture system for high-throughput perfusion three-dimensional cell culture-based assays: effect of cell culture model on the results of chemosensitivity assays. Lab Chip. 2013 Mar 21;13(6):1133-43. doi: 10.1039/c2lc41264k.

    PubMed 23353927

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: status not confirmed, as of the sponsor's last update on 10 Aug 2017. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. 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 NCT02791607, which also lists 3 linked publications.

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 Aug 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in