Expression & Epigenetic Silencing of MicroRNA for Predicting Therapeutic Response and Prognosis of HPV-negative HNSCC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-17

Study Completion Date

2023-03-14

Brief Summary

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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.

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Detailed Description

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\* 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.

Conditions

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Head and Neck Squamous Cell Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Not interventional

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with a known or suspected diagnosis of HNSCC

* Any primary site may be included, except nonkeratinizing nasopharyngeal SCC or lip SCC.
* Patients are planned for diagnostic biopsies for suspected HNSCC, or for therapeutic surgery for HNSCC.
* Patients are naïve to radiation to the head and neck, prior to research biopsies.
* Patients have not received chemotherapy for the diagnosis of HNSCC, prior to research biopsies.
* Age \> 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Patients sign an informed consent, agreeing to fresh tumor biopsy as well as distant normal mucosal biopsy for purposes of described research. Research biopsies will be in addition to planned surgery. In cases where tumor resection is planned, a representative part of the tumor will be submitted for research purposes.