Human Papillomavirus (HPV) in Squamous Cell Carcinoma of the Head and Neck
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Purpose
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..
| Condition |
|---|
|
Epidemiology |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Retrospective Trial to Assess HPV Epidemiology in Squamous Cell Carcinoma of Head and Neck |
Parafin blocks from squamous cell carcinoma of head and neck
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Sq.CC of head and neck TASMC |
| hadassa Jerusalem |
| sheba hospital |
| rambam Haifa |
| belinson Petah Tikva |
| Nazeret |
| soroka beer sheva |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
Inclusion Criteria:
- SCC of the oral cavity, oropharynx, hypopharynx, larynx and paranasal sinuses.
Exclusion Criteria:
- pregnancy,
- age < 18
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Tel Aviv medical center |
| ClinicalTrials.gov Identifier: | NCT01079546 History of Changes |
| Other Study ID Numbers: | TASMC ZG09 156 CTIL |
| Study First Received: | March 2, 2010 |
| Last Updated: | March 2, 2010 |
| Health Authority: | Israel: The Israel National Institute for Health Policy Research and Health Services Research |
Keywords provided by Tel-Aviv Sourasky Medical Center:
|
HPV, Israel, Squamous cell carcinoma of head and neck |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Neoplasms by Site |
ClinicalTrials.gov processed this record on May 19, 2013