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

New Mexico Cancer Research Alliance

Status: Completed

Conditions: Head and Neck Squamous Cell Carcinoma

Treatments: Other: Not interventional

Study type: Observational

Funder types: Other

Identifiers

NCT03953443

INST 1008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

• Nonkeratinizing nasopharyngeal carcinoma
• Lip squamous cell carcinoma