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Head and Neck Squamous Cell CarcinomaNCT05008796

PD-L1 Expression on CTCs in HNSCC Patients Underwent Curative CCRT

An observational study of Head and Neck Squamous Cell Carcinoma and Circulating Tumor Cell, 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

Head and neck squamous cell carcinoma (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
How many people
50 participants
Where
1 siteTaiwan
Study dates
1 Aug 2021to 31 Jul 2022
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: Stage III-IV head and neck squamous cell carcinoma patients, except those with P16 positive oropharyngeal cancer patients, who are going to do curative platinum-based CCRT.

Who may be able to join

  • Patients with head and neck squamous cell carcinoma with age at diagnosis ≥ 20 years
  • Stage III-IV according to AJCC 8th ed.
  • Intent to receive curative concurrent chemoradiotherapy (CCRT)
  • 10 healthy donors without any cancer diagnosis within 5 years

Who cannot join

  • P16 positive oropharyngeal cancer
  • Non-Platinum based CCRT
  • Previous diagnosed with cancer within 3 years
  • Synchronous cancer
  • Poor compliance, cannot cooperate for blood sampling for CTCs isolation as time schedule or clinical treatment or follow-up

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting
  • Chang Gung Memorial Hospital

    Taoyuan, 333

    Pei-Wei Huang, MD, +8863281000 ext. 2517, freewind_05@yahoo.com.tw

    Pei-Wei Huang, MD

    Recruiting

Other trials in Taiwan

About this study

Official title: Correlation Between PD-L1 Expression on Circulating Tumor Cells and Outcomes in Head and Neck Cancer Patients Treating With Curative Concurrent Chemo-radiotherapy

Head and neck squamous cell carcinoma (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. Unfortunately, the incidence and death of HNSCC seemed to be increasing in Taiwan. Currently, the primary treatments of HNSCC are mainly surgery, radiotherapy, chemotherapy or targeted therapy or concurrent chemoradiotherapy. Immune checkpoint inhibitors become an emerging treatment in recent days. However, how to select adequate patient by using biomarkers remains an unsolved problem. Therefore, investigator have developed a new method for isolation and detection of circulating tumor cells (CTCs) in HNSCC patients. Moreover, the expression of immune markers (such as PD-L1, PD-L2, PD-1) on CTCs or immune cells might be a good target to study. Investigator's preliminary data found CTCs and circulating cancer stem-like cells but not PD-1 expression levels on peripheral T cells in patients with recurrence or metastasis HNSCC did not associated with overall survival. Therefore, investigators are wondering if PD-L1 more specific due to it expression on cancer cells. Therefore, in the 3-year project, investigators will utilize developing device and protocol in first year and then enroll 40 freshly diagnosed participants with head and neck cancer at stage III-IV with intent to receive curative concurrent chemo-radiotherapy (CCRT), and then analyze CTCs, PD-L1 expression levels on CTCs. Blood sample will be taken before, during (definition: 3-6 weeks after start RT) and after (definition: 4 +/-2 weeks after complete CCRT) completion of CCRT. Investigators will also enroll 10 health participants and taking blood sample for 3 times and follow up. 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, investigators will clarify the correlation between clinical outcomes and expression of PD-L1 on CTCs in head and neck patients. This could be a new biomarker for clinical cancer care.

Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Neoplastic Cells, Circulating

What is being measured

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

  1. Progression-free survival rate

    Measured: 1 year

Secondary outcomes (3)
  1. Loco-regional recurrence rate

    Measured: 1 year

  2. Distant metastasis rate

    Measured: 1 year

  3. overall survival rate

    Measured: 1 year

Timeline

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

  1. First posted17 Aug 2021
  2. Study start1 Aug 2021
  3. Primary completion31 Jul 2022 (estimated)
  4. Study completion31 Jul 2022 (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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05008796
Sponsor's protocol ID
202002049B0
Status last verified
Aug 2021
First submitted
12 Aug 2021
Last updated
18 Aug 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Head and Neck Squamous Cell Carcinoma and Circulating Tumor Cell, 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 4 inclusion and 5 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 18 Aug 2021. 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?

Contact Pei-Wei H, MD (+88633281000 ext. 2517, freewind_05@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival rate (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 18 Aug 2021.

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