Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer
NCT ID: NCT04574635
Last Updated: 2025-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
18 participants
OBSERVATIONAL
2020-11-17
2027-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Definitive chemoradiotherapy patients
Patients undergo collection of blood samples at baseline prior to the first fraction of radiation, during week 4 of radiotherapy, on the day of the final fraction of radiotherapy, at 3 months post-radiotherapy, every 3 months during years 1 and 2, and at the time of recurrence (if applicable).
Biospecimen Collection
Undergo collection of blood samples
Interventions
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Biospecimen Collection
Undergo collection of blood samples
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Allison E. Garda, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2020-06965
Identifier Type: REGISTRY
Identifier Source: secondary_id
ROR1905
Identifier Type: OTHER
Identifier Source: secondary_id
19-011924
Identifier Type: OTHER
Identifier Source: secondary_id
ROR1905
Identifier Type: -
Identifier Source: org_study_id
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