Detecting HPV DNA in blood samples of cervical cancer patients

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

This study is trying to see if finding HPV DNA in the blood of cervical cancer patients can help doctors understand how well treatments are working and catch any cancer that comes back sooner.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Mayo Clinic (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 2 sites (Minneapolis, Minnesota and 1 other locations)
• Trial ID: NCT04574635 on ClinicalTrials.gov

What this trial studies

This observational study collects blood samples from patients with various types of cervical cancer, including primary, recurrent, and metastatic forms, to analyze the presence of circulating tumor DNA (ctDNA) from the human papillomavirus (HPV). The goal is to determine if the detection of HPV ctDNA can help predict treatment responses and facilitate earlier detection of cancer recurrence. Patients undergoing treatment such as surgery, radiotherapy, chemotherapy, or immunotherapy will be included in the study. The findings may provide valuable insights into the management of cervical cancer.

Who should consider this trial

Good fit: Ideal candidates are patients with histologically confirmed cervical adenocarcinoma, adenosquamous carcinoma, or small cell carcinoma who are undergoing definitive chemoradiotherapy.

Not a fit: Patients with other active malignancies within the past two years may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved monitoring and treatment strategies for cervical cancer patients.

How similar studies have performed: Other studies have shown promise in using ctDNA for monitoring cancer, suggesting this approach may be beneficial.

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

Where this trial is running

Minneapolis, Minnesota and 1 other locations

• University of Minnesota — Minneapolis, Minnesota, United States (NOT_YET_RECRUITING)
• Mayo Clinic in Rochester — Rochester, Minnesota, United States (RECRUITING)

Study contacts

• Principal investigator: Allison E. Garda, MD — Mayo Clinic in Rochester

Conditions: Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Infiltrating Cervical Carcinoma, Metastatic Cervical Carcinoma, Recurrent Cervical Carcinoma, Stage I Cervical Cancer FIGO 2018, Stage IA Cervical Cancer FIGO 2018, Stage IA1 Cervical Cancer FIGO 2018