Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-011924
NCT ID: NCT04574635
Sponsor Protocol Number: ROR1905
About this study
The purpose of this study is to answer whether plasma circulating tumor DNA (ctDNA) obtained by serial analysis before, during, and following surgery, radiotherapy, chemotherapy, and/or immunotherapy for cervical cancer will allow for risk stratification, individualized treatment decision making, monitoring of treatment response, and early detection of residual or recurrent disease in patients presenting with human papillomavirus (HPV) mediated cervical cancer.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age ≥ 18 years.
- Able to provide written consent.
- Patient has given permission to give tumor/blood sample for research testing.
- Histological confirmation of squamous cell carcinoma or adenosquamous carcinoma.
- 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 potential external collaborators.
- 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.
Eligibility last updated 3/24/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Allison Garda, M.D. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
855-776-0015
|
More information
Publications
Publications are currently not available