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Multidimensional and Multimodal Profiling of Oropharyngeal Carcinoma

Sponsor
Stanford University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05880797
Collaborator
(none)
1,000
Enrollment
1
Location
36
Anticipated Duration (Months)
27.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to better understand the natural history of oropharyngeal carcinoma (OPC), with or without an association with the human papilloma virus (HPV). For this study, the investigators plan to collect blood from OPC patients prior to treatment and at six subsequent time points.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Multidimensional and Multimodal Profiling of Oropharyngeal Carcinoma
    Anticipated Study Start Date :
    Aug 1, 2023
    Anticipated Primary Completion Date :
    Aug 1, 2026
    Anticipated Study Completion Date :
    Aug 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Sample collection [prior to start of treatment]

      30-50cc of blood

    2. Sample collection [up to 36 months post-op]

      30-50cc of blood

    Secondary Outcome Measures

    1. tumor sample [Day 1]

      tumor sample (FFPE) or fresh tissue post-excision or surgery, this will only be collected, if and when feasible, after the tumor has been removed post procedure.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients diagnosed with oropharyngeal carcinoma or patients with cancer of the unknown primary that is HPV associated, or possibly deemed to be originating from the oropharynx.
    Exclusion Criteria:
    • Not willing to sign consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University Palo Alto California United States 94305

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: Chris Holsinger, MD, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stanford University
    ClinicalTrials.gov Identifier:
    NCT05880797
    Other Study ID Numbers:
    • IRB-69452
    First Posted:
    May 30, 2023
    Last Update Posted:
    May 30, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Papilloma
    Oropharyngeal Neoplasms

    Study Results

    No Results Posted as of May 30, 2023