Active — Not RecruitingNot Applicable

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

United States18 participantsStarted 2020-11-17

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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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 carcinoma of 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 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 Mayo Clinic study personnel and potential 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 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

What they're measuring

Proportion of patients with undetectable circulating tumor deoxyribonucleic acid (ctDNA) posttreatment in patients with detectable ctDNA pre-treatment

Timeframe: At 6 weeks post-surgery (cohort 1), at 4-6 weeks after completion of chemotherapy and radiation (cohort 2), 4-6 weeks post End of chemotherapy and radiotherapy (cohort 3), at 8 weeks after start of chemotherapy or immunotherapy (cohort 4)

Trial details

NCT IDNCT04574635

SponsorMayo Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-09-10

View on ClinicalTrials.gov More Cervical Adenosquamous Carcinoma trials