NCT04574635Active, not recruiting
Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer
Source: ClinicalTrials.gov · Last updated 27 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 18 (actual)
- First submitted
- 23 Sept 2020
- Start date
- 17 Nov 2020
- Primary completion date
- 10 Sept 2025
- Lead sponsor
- Mayo Clinic
- Diseases
- Cervical cancer
- NCT number
- NCT04574635
What you commit to
- Study type: Observational
- Participants enrolled: 18
- From 17 Nov 2020 to the primary completion date, 10 Sept 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- 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
Other
- Pregnancy or lactation
- Inability on the part of the patient to understand the informed consent to be compliant with the protocol
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.