Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer


About this study

The purpose of this study is to answer whether plasma circulating tumor DNA (ctDNA) obtained by serial analysis before, during, and following surgery, radiotherapy, chemotherapy, and/or immunotherapy for cervical cancer will allow for risk stratification, individualized treatment decision making, monitoring of treatment response, and early detection of residual or recurrent disease in patients presenting with human papillomavirus (HPV) mediated cervical cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥ 18 years.
  • Able to provide written consent.
  • Patient has given permission to give tumor/blood sample for research testing.
  • Histological confirmation of squamous cell carcinoma or adenosquamous carcinoma.
  • Known HPV status defined as positive staining for p16 on IHC or DNA ISH for HPV.
  • Willingness to return to enrolling institution (Mayo Clinic Rochester or the University of Minnesota) for follow-up (during the Active Monitoring Phase of the study) or complete blood draws locally using study mail-in kits.
  • Consent to allow blood specimens to be shared with potential external collaborators.
  • Definitive Chemoradiotherapy for Locally Advanced Disease (FIGO Stage IB2-IIIC):
    • FIGO 2019 Stage IB2-IIIC or not a surgical candidate;
    • Plan to undergo definitive chemoradiotherapy including external beam radiotherapy, brachytherapy, and chemotherapy.

Exclusion Criteria: 

  • Other active malignancy ≤ 2 years prior to registration. 
    • EXCEPTIONS:  Non-melanotic skin cancer.
    • NOTE:  If there is a history or prior malignancy, they must not be receiving other specific treatment for cancer.
  • Pregnancy or lactation.
  • Inability on the part of the patient to understand the informed consent to be compliant with the protocol.

Eligibility last updated 3/24/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Allison Garda, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office


More information


Publications are currently not available

Mayo Clinic Footer