Head and Neck Cancer Omics/Integrated Precision Medicine (HOPE)

NCT07190573 | Recruiting

• 1 other identifier: 2025-02-141
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

Study Background and Rationale Head and neck cancer (HNC) is the sixth leading cause of cancer-related death, with over 650,000 new cases diagnosed worldwide each year. About 60% of patients are diagnosed at an advanced stage, and many experience recurrence or spread despite surgery, radiation, or chemotherapy. Major risk factors include tobacco and alcohol use, prior radiation therapy, and infection with human papillomavirus (HPV). The prognosis differs across patients due to HPV infection and genetic factors. HPV is commonly found in cancers of the tonsils and throat. Patients with HPV-positive tumors generally respond better to treatment and live longer than those who are HPV-negative. Conversely, patients with certain genetic changes, like EGFR amplification, tend to have worse outcomes. HNC can develop in the oral cavity, throat, larynx, nasal cavity, nasopharynx, and salivary glands. Squamous cell carcinoma caused by smoking is the most common type, but other types like salivary gland cancer or adenoid cystic carcinoma also occur, making the disease clinically diverse. Treatments exist, but for advanced cancers, such as advanced laryngeal cancer, the 5-year survival rate is only around 40%. HNC also affects the face and throat, which can cause breathing problems, difficulty swallowing, voice changes, and significant impact on quality of life. The effectiveness of treatment is limited by tumor diversity and complex interactions between cancer cells, immune cells, and surrounding tissue (tumor microenvironment, TME). Most research so far comes from Western populations, but genetic and viral differences in Asian patients require domestic studies. To provide personalized treatment, it is essential to collect clinical and genetic data from Korean patients and study their tumors and TME. Need for Long-term Follow-up Studies Even early-stage HNC can recur locally, with recurrence rates reported between 20-57%. Recurrent or metastatic HNC has poor prognosis, with only 20-30% surviving five years. HNC usually progresses from pre-cancerous lesions to primary tumors and then spreads to lymph nodes. The molecular mechanisms behind this progression are not fully understood. Various factors including smoking, alcohol, and HPV infection influence HNC development. HPV-positive patients show better outcomes, but their immune response may be suppressed. Therefore, continuous observation of HNC patients from early disease to recurrence is necessary to identify biomarkers that predict outcomes and to find more effective treatments. Importance of Studying Tumor Microenvironment Immune checkpoint inhibitors (ICIs) combined with chemotherapy have improved survival in HNC. For example, pembrolizumab plus chemotherapy extended median overall survival to 13 months versus 10.7 months with standard treatment. Patients with higher PD-L1 expression responded better, but some high PD-L1 patients still did not respond, and some low PD-L1 patients responded well. Clear biomarkers to predict who will benefit from ICIs are still lacking. Role of Samsung Medical Center In Korea, about 3,000 new cases of lip, oral, and throat cancer occur annually. Samsung Medical Center treated 550 of these patients in 2021, about one-fifth of national cases. More than half presented with advanced disease. Five-year survival rates for patients at Samsung Medical Center are higher than national averages: 78.5% overall, 93.2% for local tumors, and 37.8% for metastatic disease. These data show the importance of collecting patient information and samples for ongoing research. Study Objectives This study aims to: Collect clinical information from HNC patients at Samsung Medical Center. Collect tissue and blood samples at diagnosis, before and during treatment, and at disease progression or suspected recurrence. Identify biomarkers that can guide personalized treatment in the future. Study Design Eligibility Inclusion Criteria: Adults 20 years or older. Histologically confirmed HNC at any head and neck site (oral cavity, pharynx, larynx, nasal cavity, salivary glands, or other locations). Patients diagnosed elsewhere are eligible if pathology is confirmed at Samsung Medical Center. Various HNC-related cancer types including squamous cell carcinoma, adenocarcinoma, undifferentiated carcinoma, and others. Scheduled for or previously received appropriate treatment (surgery, radiotherapy, chemotherapy, or immunotherapy). Able to understand and sign informed consent. Exclusion Criteria: Not meeting inclusion criteria. Any other reason deemed unsuitable by the investigator. Sample Size: Approximately 350 patients per year will participate, based on the number undergoing biopsy and blood collection at Samsung Medical Center. Duration The study will last 60 months from IRB approval (\~December 31, 2030). Data and Sample Collection Clinical Data: Collect demographics, diagnosis details (location, stage, HPV status), medical history, smoking/alcoh

Conditions

Head and Neck Cancer

Keywords

head and neck cancer; squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival(OS)

  Overall survival is defined as the time from the date of study enrollment to the date of death from any cause. Survival will be analyzed using Kaplan-Meier survival plots, and the effect of clinical and treatment-realated variables on survival will be assessed using Cox's proportional hazard model and Log-rank test. A p-value \<0.05 will be considered statistivally significant.

  From study enrollment until death from any cause, assessed up to study completion (approximately 5 years.)

Secondary Outcomes (1)

• Disease-Free Survival(DFS)

  From treatment completion until disease recurrence or death from any cause, assessed up to study completion (approximately 5 years).

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 550 head and neck cancer patients visit Samsung Medical Center annually, and approximately 350 patients seek biopsy and other tests in a capable, primary care setting. Therefore, we plan to conduct this study on approximately 350 medical professionals annually.

You may qualify if:

• Adults aged 20 years or older
• Histologically confirmed head and neck cancer (including cancers of the oral cavity, pharynx, larynx, nasal cavity, salivary glands, and other head and neck sites) Patients diagnosed at outside institutions but pathologically confirmed as head and neck cancer at Samsung Medical Center are also eligible.)
• Patients with similar histologic types (including squamous cell carcinoma, undifferentiated carcinoma, poorly differentiated carcinoma, nonkeratinizing carcinoma, and adenocarcinoma), as well as cancers of unknown primary, salivary gland cancers, head and neck malignant melanoma, sarcomas, and other malignancies are eligible.
• Diagnosed with head and neckk cancer and scheduled to receive, or previously received, appropriate treatment (radiation therapy, cytotoxic chemotherapy, immune checkpoint inhibitors, or surgery).
• Ability to understand the purpose of the study and willingness to sign informed consent.

You may not qualify if:

• Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study participation.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, 06351, South Korea

RECRUITING

Related Publications (7)

• Kumar B, Cordell KG, Lee JS, Worden FP, Prince ME, Tran HH, Wolf GT, Urba SG, Chepeha DB, Teknos TN, Eisbruch A, Tsien CI, Taylor JM, D'Silva NJ, Yang K, Kurnit DM, Bauer JA, Bradford CR, Carey TE. EGFR, p16, HPV Titer, Bcl-xL and p53, sex, and smoking as indicators of response to therapy and survival in oropharyngeal cancer. J Clin Oncol. 2008 Jul 1;26(19):3128-37. doi: 10.1200/JCO.2007.12.7662. Epub 2008 May 12.

  PMID: 18474878 BACKGROUND

• Vermorken JB, Remenar E, van Herpen C, Gorlia T, Mesia R, Degardin M, Stewart JS, Jelic S, Betka J, Preiss JH, van den Weyngaert D, Awada A, Cupissol D, Kienzer HR, Rey A, Desaunois I, Bernier J, Lefebvre JL; EORTC 24971/TAX 323 Study Group. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1695-704. doi: 10.1056/NEJMoa071028.

  PMID: 17960012 BACKGROUND

• Seiwert TY, Salama JK, Vokes EE. The concurrent chemoradiation paradigm--general principles. Nat Clin Pract Oncol. 2007 Feb;4(2):86-100. doi: 10.1038/ncponc0714.

  PMID: 17259930 BACKGROUND

• Seiwert TY, Salama JK, Vokes EE. The chemoradiation paradigm in head and neck cancer. Nat Clin Pract Oncol. 2007 Mar;4(3):156-71. doi: 10.1038/ncponc0750.

  PMID: 17327856 BACKGROUND

• Posner MR, Hershock DM, Blajman CR, Mickiewicz E, Winquist E, Gorbounova V, Tjulandin S, Shin DM, Cullen K, Ervin TJ, Murphy BA, Raez LE, Cohen RB, Spaulding M, Tishler RB, Roth B, Viroglio Rdel C, Venkatesan V, Romanov I, Agarwala S, Harter KW, Dugan M, Cmelak A, Markoe AM, Read PW, Steinbrenner L, Colevas AD, Norris CM Jr, Haddad RI; TAX 324 Study Group. Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1705-15. doi: 10.1056/NEJMoa070956.

  PMID: 17960013 BACKGROUND

• Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, Jones CU, Sur R, Raben D, Jassem J, Ove R, Kies MS, Baselga J, Youssoufian H, Amellal N, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006 Feb 9;354(6):567-78. doi: 10.1056/NEJMoa053422.

  PMID: 16467544 BACKGROUND

• Leemans CR, Braakhuis BJ, Brakenhoff RH. The molecular biology of head and neck cancer. Nat Rev Cancer. 2011 Jan;11(1):9-22. doi: 10.1038/nrc2982. Epub 2010 Dec 16.

  PMID: 21160525 BACKGROUND

Related Links

• Hah, J. H. (2012). Personalized Treatment of Head and Neck Cancers and the Role of Head and Neck Surgeons. Korean Journal of Otorhinolaryngology-Head and Neck Surgery, 55(8), 471-475.

Biospecimen

Retention: SAMPLES WITH DNA

Tissue: Fresh tissue will be collected whenever feasible. Residual samples from diagnostic or therapeutic biopsies and surgical resections will also be utilized. Additional residual tissue may be obtained during follow-up biopsies performed for suspected recurrence or treatment response assessment. At the time of surgery, tumor tissue, adjacent normal tissue, distant normal tissue, and lymph nodes will be collected. Blood: Peripheral blood will be collected at defined timepoints: prior to treatment, during treatment (for CCRT: baseline, 3 ± 1 weeks, 6 ± 1 weeks; for immunotherapy: baseline, 3 ± 1 weeks, 6 ± 1 weeks, 12 ± 3 weeks), during follow-up imaging, and at disease progression. Each draw will obtain 20-30 mL. Storage: All tissue and blood specimens will be stored in a designated, secure cryogenic facility, strictly for research purposes, without compromising clinical diagnosis or treatment.

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Central Study Contacts

Nayeon Choi, M.D.

CONTACT

+821089619355; choinayeon@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinatr, Head and Neck Cancer Center; Assitant Professor, Department of Otorhinolaryngology, Samsung Medical Center/Sungkyunkwan University School of Medicine

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 24, 2025
• Study Start: April 25, 2025
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): January 31, 2030
• Last Updated: September 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)