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 for follow-up (during the Active Monitoring Phase of the study)
- Consent to allow blood specimens to be shared with potential external collaborators
- Cohort #1: Surgery Alone for Early Stage Disease (FIGO Stage IA-IB1)
- FIGO 2019 Stage IA1, IA2, IB1
- Plan to undergo surgery including but not limited to trachelectomy, radical hysterectomy, and lymph node dissection
- Cohort #2: Post-operative Radiation +/- Chemotherapy for Intermediate and High Risk Factors
- Any FIGO Stage
- Status post any definitive surgical procedure (e.g. radical hysterectomy and lymph node dissection) and on final pathology found to have risk factors:
- Intermediate risk[4]: LVSI, deep cervical stromal invasion, tumor size > 4 cm
- High risk[2]: pelvic or para-aortic lymph nodes, parametrial invasion, positive surgical margins
- Plan to undergo pelvic +/- para-aortic radiotherapy with or without chemotherapy per standard of care
- Cohort #3: 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
- Cohort #4: Systemic Treatment for Recurrent or Metastatic Disease
- Any recurrence (local, regional, or distant) after prior treatment for cervical cancer
- Metastases at first diagnosis without prior treatment
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
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. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available