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

Launched by MAYO CLINIC · Sep 28, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at how well a specific type of DNA, called circulating tumor DNA (ctDNA), can be detected in the blood of women who have cervical cancer. The researchers want to see if finding this DNA can help predict how well patients will respond to their treatments, which may include surgery, radiation, chemotherapy, or immunotherapy. The study is open to women with different types and stages of cervical cancer, including those whose cancer is newly diagnosed, has come back after treatment, or has spread to other parts of the body.

To be eligible for this trial, participants need to be able to provide written consent and have a confirmed diagnosis of a specific type of cervical cancer that tests positive for HPV (the virus that can cause cervical cancer). They should also be willing to return for follow-up visits during the study. Participants can expect to provide blood samples for testing, and their progress will be monitored closely. This research could help doctors find ways to detect cervical cancer recurrence earlier and improve treatment strategies for patients.

Gender

FEMALE

Eligibility criteria

• 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