Who is eligible for clinical trial NCT04574635?

Participants must meet protocol criteria for Cervical Adenosquamous Carcinoma. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT04574635 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-10-24

Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer (NCT04574635)

🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Mayo Clinic

🩺 Plain-English Summary (8th-Grade Level)

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 join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (6 items).

Location: University of Minnesota — Minneapolis, Minnesota

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

University of Minnesota — Minneapolis, Minnesota
Mayo Clinic in Rochester — Rochester, Minnesota

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗