Clinical trial NCT03953443: Expression & Epigenetic Silencing of MicroRNA for Predicting Therapeutic Response and Prognosis of HPV-negative HNSCC
Official title: INST 1008: Expression and Epigenetic Silencing of MicroRNA for Predicting the Therapeutic Response and Prognosis of HPV-negative Head and Neck Squamous Cell Carcinoma (HNSCC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Squamous Cell Carcinoma
Lead sponsor: New Mexico Cancer Research Alliance
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with known or suspected HNSCC

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Identify tumor specific microRNAs (miRs) whose expression increases or decreases by over 2 fold in fresh tumor vs. distant normal mucosa from patients with head and neck squamous cell carcinoma (HNSCC) negative for human papillomavirus (HPV)
timeFrame: As long as needed to collect 15 HPV-negative tumor-mucosal sample pairs and complete sequencing, up to 10 years
measure: Identify miRs whose reduced expression in HPV-negative HNSCC is due to promoter methylation
timeFrame: As long as needed to complete sequencing and analyze results, up to 5 years
measure: Define the statistical association between the expression of tumor specific miRs, miR methylation, and the therapeutic response and prognosis of HPV-negative HNSCC using patient medical records
timeFrame: As long as needed to collect and analyze information from medical records, up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico - Cancer Center
state: New Mexico
Study officials:
affiliation: University of New Mexico Comprehensive Cancer Center
name: Garth Olson, MD
role: PRINCIPAL_INVESTIGATOR
References: