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

Last updated: March 26, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Lung Cancer

Cervical Cancer

Treatment

Biospecimen Collection

Clinical Study ID

NCT04574635
ROR1905
ROR1905
19-011924
NCI-2020-06965
  • Ages > 18
  • Female

Study Summary

This study collects blood samples to determine if the DNA of HPV that causes cervical cancer can be detected in patients with cervical cancer that is new (primary), has come back (recurrent), or has spread to other places in the body (metastatic) and are undergoing treatment with surgery, radiotherapy, chemotherapy, and/or immunotherapy. Researchers may use this information to predict response (good or bad) of the cervical cancer to treatment and detect recurrent cancer sooner.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Able to provide written consent

  • Patient has given permission to give tumor/blood sample for research testing

  • Histological confirmation of adenocarcinoma, adenosquamous, or small cell carcinomaof the cervix

  • 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 theUniversity of Minnesota) for follow-up (during the Active Monitoring Phase of thestudy) or complete blood draws locally using study mail-in kits

  • Consent to allow blood specimens to be shared with Mayo Clinic study personnel andpotential external collaborators for sample analysis

  • 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 beamradiotherapy, brachytherapy, and chemotherapy

Exclusion

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 receivingother specific treatment for cancer

  • Pregnancy or lactation

  • Inability on the part of the patient to understand the informed consent to becompliant with the protocol

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Biospecimen Collection
Phase:
Study Start date:
November 17, 2020
Estimated Completion Date:
November 30, 2030

Connect with a study center

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

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