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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01079546
Recruitment Status : Unknown
Verified March 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : March 3, 2010
Last Update Posted : March 3, 2010
Information provided by:
Tel-Aviv Sourasky Medical Center

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..

Condition or disease

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Trial to Assess HPV Epidemiology in Squamous Cell Carcinoma of Head and Neck
Study Start Date : January 2010
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Sq.CC of head and neck TASMC
hadassa Jerusalem
sheba hospital
rambam Haifa
belinson Petah Tikva
soroka beer sheva

Biospecimen Retention:   Samples With DNA
Parafin blocks from squamous cell carcinoma of head and neck

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy,
  • age < 18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01079546

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The Laboratory For Applied Cancer Research, Sourasky Medical Center
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
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Responsible Party: Tel Aviv medical center Identifier: NCT01079546    
Other Study ID Numbers: TASMC ZG09 156 CTIL
First Posted: March 3, 2010    Key Record Dates
Last Update Posted: March 3, 2010
Last Verified: March 2010
Keywords provided by Tel-Aviv Sourasky Medical Center:
HPV, Israel, Squamous cell carcinoma of head and neck
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site