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Trial record 31 of 127 for:    exosomes

Exosome Testing as a Screening Modality for Human Papillomavirus-Positive Oropharyngeal Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT02147418
Recruitment Status : Recruiting
First Posted : May 26, 2014
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance

Brief Summary:
Cancer of the oropharynx (middle, side and back walls of the throat; back of the tongue; soft palate, and tonsils), or oropharyngeal squamous cell carcinoma (OPSCC), has been on the rise in the United States. Human papillomavirus (HPV) has been recognized in many of these cancers, and testing for HPV has contributed to the higher reported rates of OPSCC. In this study, our goal is to develop a new test that can detect certain HPV proteins in the blood or saliva to help improve detection of OPSCC.

Condition or disease
Oropharyngeal Cancer

Detailed Description:
While secondary screening strategies have successfully reduced the rate of HPV-positive cervical cancers, an effective screening modality for HPV-OPSCC does not exist. A central problem in the early diagnosis of HPV-OPSCC is the relative inaccessibility of the tonsillar crypts, where oncogenic infections are thought to originate. Unlike the relatively smooth surface of the cervix which permits mechanical sampling with Pap tests and which can be evaluated visually for evidence of dysplasia, much of the tonsillar epithelium is found below the surface in a complex network. As a consequence, any screening modality cannot depend upon direct access to malignant lesions. What is needed is a minimally invasive, diffusible or circulating marker of HPV-OPSCC, and a means to collect and detect it.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: An Observational, Single-Institution Pilot/Feasibility Study of Exosome Testing as a Screening Modality for Human Papillomavirus-Positive Oropharyngeal Squamous Cell Carcinoma
Study Start Date : February 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Group 1: HPV-positive Cancer
Oropharyngeal cancer patients testing positive for human papillomavirus (HPV)
Group 2: HPV-positive Cancer
Oropharyngeal cancer patients who test positive for human papillomavirus (HPV)
Group 3: Healthy Controls
Patients with benign conditions



Primary Outcome Measures :
  1. Cultured Cell Exosome Protein Signature Outcome Measure [ Time Frame: 1 month ]
    The presence of unique proteins obtained from primary cell cultures derived from HPV-OPSCC confirmed patients will be compared to normal tonsillar epithelial cells and established cell lines. The distribution of these protein signatures will be compared in HPV-OPSCC and normal epithelial cells.


Other Outcome Measures:
  1. Exosome Signatures Oropharyngeal Rinse Measure [ Time Frame: 1 month ]
    Compare exosome protein signatures generated from cells obtained through oropharyngeal rinses of patients with HPV-positive OPSCC and normal controls to identify an exosome protein marker that is absent (or present at a different, statistically significant level) in the oropharyngeal rinses of normal controls.


Biospecimen Retention:   Samples Without DNA
All oropharyngeal rinse (gargle) specimens will be processed within 24 hours of collection. Any remaining material after testing will be stored for a period not to exceed 1 year in a secure location.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The patient population will consist of adults presenting to the Division of Otolaryngology - Head and Neck Surgery at the University of New Mexico with previously untreated OPSCC. Both HPV-positive and HPV-negative malignancies will be collected as the study and control groups, respectively. In addition, saliva samples will be collected from patients presenting with benign conditions as a further negative control.
Criteria

Inclusion Criteria (Cancer Patients):

  • Male or Female
  • Age greater than or equal to 18
  • Previously untreated, pathologically confirmed OPSCC (HPV+ or HPV-)
  • Ability to understand study information and provide written consent for participation.

Inclusion Criteria (Non-cancer Patients):

  • Male or Female
  • Age greater than or equal to 18
  • Ability to understand study information and provide written consent for participation

Exclusion Criteria:

  • Age less than 18 years
  • Prisoners
  • Pregnant women
  • Patients with mental disability

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 ClinicalTrials.gov identifier (NCT number): NCT02147418


Contacts
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Contact: Andrew Cowan, MD AnCowan@salud.unm.edu
Contact: Valerie Parks, RN 505-925-0390 vparks@salud.unm.edu

Locations
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United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131-0001
Contact: Andrew Cowan, MD       AnCowan@salud.unm.edu   
Contact: Valerie Parks, RN    505-925-0390    vparks@salud.unm.edu   
Principal Investigator: Andrew Cowan, MD         
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Investigators
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Principal Investigator: Andrew Cowan, MD University of New Mexico Cancer Center

Additional Information:
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Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT02147418     History of Changes
Other Study ID Numbers: INST 1310
First Posted: May 26, 2014    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by New Mexico Cancer Care Alliance:
Head and neck cancer
Throat cancer
Human papillomavirus
HPV
Exosome
Diagnostic
Early Detection
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Oropharyngeal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases