Human Papillomavirus (HPV) in Squamous Cell Carcinoma of the Head and Neck

NCT01079546 | Unknown DMC

• 1 other identifier: TASMC ZG09 156 CTIL
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The rationale for this study proposal is derived from previous case series demonstrating that up to 60% of patients with HNSCC, especially in the oropharynx are associated with high risk HPV infection. In this study, we will characterize the association between HPV infection and HNSCC in Israel and establish a program for its diagnosis and management based on HPV as a biomarker. The rationale for the proposed research is that once it is known which types of HPV are associated with HNSCC, this information can be used to direct diagnosis and screening effort to high risk population. Our approach is based on establishing a multicenter consortium of leading researchers that will establish a joint database of demographic, clinical and biological data from various regions in Israel. For this we have assembled a multidisciplinary research team with the scope and breath (surgical oncology, pathology, virology and molecular biology) needed to complete all phases of the research successfully. The research will be coordinated and performed at the Applied Cancer Research Laboratory, Tel Aviv Sourasky Medical Center. The patients will be recruited from 7 tertiary medical centers in Israel: Ichilov, Bellinson, Hadassa, Rambam, Soroka, Sheba and Nazeret..

Conditions

Epidemiology

Keywords

HPV, Israel, Squamous cell carcinoma of head and neck

Study Arms (7)

Sq.CC of head and neck TASMC

hadassa Jerusalem

sheba hospital

rambam Haifa

belinson Petah Tikva

Nazeret

soroka beer sheva

Eligibility Criteria

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

Study Population

The group will include patients treated with primary surgery or biopsy, with or without adjuvant radiotherapy between 1998 and 2010 for SCC of the oral cavity, oropharynx, hypopharynx, larynx and paranasal sinuses. The anatomic site and extent of the primary tumor will be documented. The TNM classification of will be based on the staging system revised by the American Joint Committee on Cancer (AJCC). Patients will be recruited from seven national cancer referral hospitals, including Soroka Medical Center in the Negev (Beer Sheva), Sourasky Medical Center (Tel Aviv), Rabin Medical Center (Petach Tikva), Hadassa Medical (Jerusalem), Rambam Medical Center (Haifa), Sheba medical center (Ramat- Gan) and French Hospital Nazareth (Nazareth). These centers cover almost the entire population in Israel, including Israeli Jews, Bedouins, Druze and Israeli Arab population.

You may qualify if:

• SCC of the oral cavity, oropharynx, hypopharynx, larynx and paranasal sinuses.

You may not qualify if:

• pregnancy,
• age \< 18

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

The Laboratory For Applied Cancer Research, Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Biospecimen

Retention: SAMPLES WITH DNA

Parafin blocks from squamous cell carcinoma of head and neck

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 3, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: January 1, 2011
• Last Updated: March 3, 2010

Record last verified: 2010-03

Locations

IL (1)