NCT05522881

Brief Summary

We will use the next-generation sequencing (NGS) technology to identify genomic alterations of Taiwanese HPV positive and negative oropharyngeal squamous cell carcinoma (OPSCC) for novel biomarker development and the study design of potential clinical trials or translational research.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
410

participants targeted

Target at P75+ for all trials

Timeline
42mo left

Started Nov 2022

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
recruiting

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 Progress51%
Nov 2022Dec 2029

First Submitted

Initial submission to the registry

August 23, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 31, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

November 25, 2022

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

January 20, 2026

Status Verified

December 1, 2025

Enrollment Period

7 years

First QC Date

August 23, 2022

Last Update Submit

January 15, 2026

Conditions

Oropharyngeal Squamous Cell Carcinoma

Keywords

human papillomavirusoropharyngeal squamous cell carcinomanext-generation sequencingprecision medicine

Outcome Measures

Primary Outcomes (1)

  • To enroll a total of 300 patients with OPSCC who fit the criteria of this study in the enrolled period

    To enroll a total of 300 patients with OPSCC who fit the criteria of this study in the enrolled period

    5 years of proposed observation period

Secondary Outcomes (4)

  • To perform next generation sequencing analysis of OPSCC tumor tissues

    5 years of proposed observation period

  • Collect clinical data of OPSCC

    5 years of proposed observation period

  • To compare the difference of the genetic and molecular profiles among patients with HPV positive and negative OPSCC

    5 years of proposed observation period

  • To compare the difference of genetic and molecular profiles between early (stage I and II) and advanced stage (stage III and IV) of HPV positive OPSCC

    5 years of proposed observation period

Study Arms (6)

HPV positive-Post treatment

The subject has received any anti-cancer treatment with pathological report of squamous cell carcinoma of oropharynx (soft palate, tonsil, base of tongue, pharyngeal wall, uvula or vallecula) and positive p16 immunohistochemical staining.

HPV negative-Post treatment

The subject has received any anti-cancer treatment with pathological report of squamous cell carcinoma of oropharynx (soft palate, tonsil, base of tongue, pharyngeal wall, uvula or vallecula) and negative p16 immunohistochemical staining.

HPV positive-Treatment-naïve

The subject has received no anti-cancer treatment with pathological report of squamous cell carcinoma of oropharynx (soft palate, tonsil, base of tongue, pharyngeal wall, uvula or vallecula) and positive p16 immunohistochemical staining.

HPV negative-Treatment-naïve

The subject has received no anti-cancer treatment with pathological report of squamous cell carcinoma of oropharynx (soft palate, tonsil, base of tongue, pharyngeal wall, uvula or vallecula) and negative p16 immunohistochemical staining.

reference subgroup

60 patients with head and neck SCC (excluding OPSCC)

recurrence subgroup

pairs of primary and recurrent tumors (at the first distal or local recurrence) of head and neck SCC

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

To enroll a total of 410 patients with head and neck SCC

You may qualify if:

  • Ages 20 and above
  • Pathological reported as squamous cell carcinoma of head and neck
  • Available p16 immunohistochemical staining status (restricted to the OPSCC subgroup)
  • Participants have both archival tumor tissues from the primary head and neck SCC and from the first recurrent tumor (for the recurrence subgroup)
  • Recurrence status is defined as the reappearance of the disease occurring more than 6 months following curative surgery and/or chemoradiotherapy in the recurrence subgroup
  • Willingness to provide archival or newly obtained tumor tissues for current study proposal
  • Life expectancy more than 3 months
  • Patients fully understand the protocol with the willingness to have regular follow-up

You may not qualify if:

  • Inability to cooperate by providing a complete medical history
  • No available tumor tissues for genetic testing
  • Undesirable compliance
  • Having a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., cervical carcinoma in situ) that have undergone potentially curative therapy are not excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

RECRUITING

China Medical University Hospital

Taichung, 400, Taiwan

RECRUITING

Taichung Veterans General Hospital

Taichung, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, Taiwan

RECRUITING

Pei-Jen Alex Lou

Taipei, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

One H\&E-stained slide, and at least 10 unstained tissue on non-coated slides (5 um thickness) for cancer panel-based NGS analysis.20 unstained tissue on non-coated slides (4 um thickness) will be required for HPV genotyping testing. 20 ml Cell-Free DNA blood will be collected from the subjects within two weeks of the study registration. Of the treatment-naïve group, 20 ml blood specimens will be additionally collected at week 4 and 8 after the curative therapy is completed then every 6 months until the study withdrawal or tumor recurrence. For all subjects receiving the curative therapy, 20 ml of blood specimen will be collected when tumor recurrence is diagnosed at follow-up after the study registration.

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Officials

  • Pei-Jen Lou, MD, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

  • Shang-Hung Chen, MD, PhD

    National Health Research Institutes, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shang-Hung Chen, MD.PhD

CONTACT

886 (06) 7000123bryanchen@nhri.edu.tw

Pei-Jen Lou, MD, PhD

CONTACT

886 (02) 23123456pjlou@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2022

First Posted

August 31, 2022

Study Start

November 25, 2022

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

January 20, 2026

Record last verified: 2025-12

Locations

TW(7)