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Clinical Trial Summary

A two-part molecular epidemiological study will be conducted to comprehensively assess the association between miR expression and miR promoter methylation and the response to therapy and prognosis in primary, HPV-negative HNSCC patients. Part 1 will be a prospective collection of 25 pairs of fresh tumor-distant normal mucosal tissue in patients with HNSCC. Ultimately, 15 HPV-negative tumor-mucosal pairs will be utilized for discovery work in identifying miRs whose expression is up- or down-regulated in tumors. Part 2 will test the association between miR expression and miR promoter methylation, and therapeutic response and survival in all archived surgical cases of HPV-negative HNSCC at University of New Mexico Hospital (UNMH) collected after 1990.


Clinical Trial Description

* Part 1, Prospective Collection of Fresh Tumor-Distant Normal Pairs The investigators will prospectively collect 25 pairs of fresh HNSCC tumor-distant normal mucosal tissue. * Part 2, Retrospective Molecular Epidemiology Study of the Association of miRs with Therapeutic Response and Prognosis in HNSCC. The investigators will comprehensively test the association between miR expression and miR promoter methylation, and the response to therapy and survival in all cases of surgical HPV-negative HNSCC at UNMH collected after 1990. Lip and nonkeratinizing nasopharyngeal cases will be excluded as these are etiologically distinct and related to cutaneous SCC or to EB virus infection, respectively. No cases will be excluded due to gender, age, race or ethnicity. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03953443
Study type Observational
Source New Mexico Cancer Care Alliance
Contact
Status Active, not recruiting
Phase
Start date December 17, 2010
Completion date December 31, 2026

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