Detecting HPV DNA in Anal and Cervical Cancers

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Brief Title

Detecting HPV DNA in Anal and Cervical Cancers

Official Title

Circulating HPV DNA in Cancers of the Anus and Uterine Cervix Treated With Definitive Radiation Therapy

Brief Summary

      This is a research study for individuals who have cancer associated with human papillomavirus
      (HPV) and are being treated with radiation as part of standard care for their cancer. Doctors
      leading this study will use blood tests to find out if they can detect the HPV virus in the
      blood of study participants before, during, and after radiation treatment. They will also
      collect blood and archival tumor tissue (from a previous biopsy) to perform other tests in
      the future that could provide more information about HPV-associated cancers and how they
      respond to treatment. Participation in this study will last approximately 2 years.
    



Study Type

Observational


Primary Outcome

Rate of Participants With Detectable Circulating HPV DNA in Blood/Tumor Samples

Secondary Outcome

 Accuracy of HPV DNA Levels in Predicting Cancer Recurrence at 24 Months

Condition

Cervical Cancer

Intervention

Radiation Treatment With or Without Chemotherapy

Study Arms / Comparison Groups

 Retrospective (Participants Who Have Already Been Treated for HPV-Related Cancer Before Study)
Description:  This group will use medical records from participants who have already received chemoradiation for their HPV-related anal or cervical cancer at a time before this study started. Because they have already received treatment, these participants will provide previous blood/tumor tissue samples that contain detectable HPV DNA as well as at least one post-treatment sample that their doctor collected before the study. Data from these previously collected samples will be compared to current samples from participants who are actively enrolled in this study in present day (chart review).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Radiation

Estimated Enrollment

20

Start Date

October 6, 2020

Completion Date

November 15, 2023

Primary Completion Date

November 15, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Stage I-III anal cancer or stage I-IVA cervical cancer that is p16+ based on
             immunohistochemistry.

          -  Age ≥ 18 years

          -  Planned to undergo radiation therapy as definitive treatment, with or without
             concurrent systemic therapy

        Exclusion Criteria:

          -  Anal carcinoma not associated with HPV-16, 18, 31, 33, or 35 will be removed from the

          -  Planned to undergo radiation therapy as an adjuvant or post-operative therapy
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Christina Son, MD, 773-702-6870, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04857528

Organization ID

IRB20-0410


Responsible Party

Sponsor

Study Sponsor

University of Chicago


Study Sponsor

Christina Son, MD, Principal Investigator, University of Chicago


Verification Date

June 2021