RECRUITING

Oropharynx (OPX) Biomarker Trial

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Conditions

Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC V8Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC V8Metastatic Oropharyngeal Squamous Cell CarcinomaOropharyngeal Squamous Cell CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaStage III Oropharyngeal (p16-Negative) Carcinoma AJCC V8Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC V8Head and Neck CarcinomaHead and Neck NeoplasmSalivary Gland NeoplasmsThyroid Gland Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this research is to identify a biomarker that is exists when human papillomavirus (HPV) mediated oropharyngeal squamous cell carcinoma is present and does not exist when HPV mediated oropharyngeal squamous cell carcinoma is absent.

Official Title

Oropharynx (OPX) Biomarker Trial

Quick Facts

Study Start:2019-11-15
Study Completion:2029-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06356272

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Able to provide written consent
  3. * Groups 1-3:
  4. * Must undergo p16 staining on biopsy for enrollment
  5. * Patients with \< 70% of tumor cells positive for p16 will be considered p16 negative
  6. * Must undergo HPV16 family in situ hybridization (ISH) and/or RNA on biopsy or surgical specimen, unless amount of tissue is too small to have conclusive HPV ISH testing done on it
  7. * Willingness and intent to return in person to enrolling institution for follow-up (during the Active Monitoring Phase of the study) for at least 2 of the standard follow-up time points for a total of 3 time-points including pre-treatment. A participant who does not return in person to Mayo Clinic Rochester for every standard of care post-treatment follow up will not be considered deviating from the protocol
  8. * Group 4:
  9. * Clinical suspicion or histopathologic diagnosis of head and neck cancer or neoplasm
  10. * Primary salivary neoplasm
  11. * Primary thyroid neoplasm
  12. * Primary head and neck neoplasm
  13. * Multi-cancer early detection (MCED) testing concerning for cancer
  14. * Patient has given permission to give his/her tumor/tissue/blood/saliva sample for research testing
  15. * Ability to complete questionnaire(s) by themselves or with assistance
  1. * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
  2. * Groups 1-3:
  3. * Other active malignancy ≤ 5 years prior to registration
  4. * EXCEPTIONS: Non-melanotic skin cancer, non-metastatic thyroid cancer, non-metastatic prostate cancer, carcinoma-in-situ of the cervix, HPV+ oropharyngeal squamous cell carcinoma (SCC) (which can be enrolled in group 3)
  5. * NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer
  6. * History of any head and neck malignancy, other than the tumor for which they are being treated
  7. * Group 4, Cohort A, B, C:
  8. * Other active malignancy ≤ 5 years prior to registration
  9. * EXCEPTIONS: Non-metastatic prostate cancer, carcinoma-in-situ of the cervix, non metastatic cutaneous basal cell carcinoma
  10. * NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer
  11. * History of any head and neck malignancy, other than the present neoplasm
  12. * Note these are clarifications of inclusion into Group 4, Cohorts D and E:
  13. * Presence of other active malignancy or recurrent head and neck neoplasms are allowed in this arm
  14. * Receipt of cancer specific therapy for other malignancy is allowed in this arm

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

Kathryn M. Van Abel, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Kathryn M. Van Abel, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-11-15
Study Completion Date2029-11-30

Study Record Updates

Study Start Date2019-11-15
Study Completion Date2029-11-30

Terms related to this study

Additional Relevant MeSH Terms

  • Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC V8
  • Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC V8
  • Metastatic Oropharyngeal Squamous Cell Carcinoma
  • Oropharyngeal Squamous Cell Carcinoma
  • Recurrent Oropharyngeal Squamous Cell Carcinoma
  • Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC V8
  • Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC V8
  • Head and Neck Carcinoma
  • Head and Neck Neoplasm
  • Salivary Gland Neoplasms
  • Thyroid Gland Neoplasm