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

N/AActive Not RecruitingNCT04574635

Mayo Clinic18 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma, Not Otherwise Specified Infiltrating Cervical Carcinoma Metastatic Cervical Carcinoma Recurrent Cervical Carcinoma Stage I Cervical Cancer FIGO 2018

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 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

Locations (2)

University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Proportion of patients with undetectable circulating tumor deoxyribonucleic acid (ctDNA) posttreatment in patients with detectable ctDNA pre-treatment

The proportion will be reported along with the exact 95% binomial confidence interval. Additionally will report the mean standard deviation and median interquartile range ctDNA post-treatment in these patients.

Time frame: At 6 weeks post-surgery (cohort 1), at 4-6 weeks after completion of chemotherapy and radiation (cohort 2), 4-6 weeks post End of chemotherapy and radiotherapy (cohort 3), at 8 weeks after start of chemotherapy or immunotherapy (cohort 4)

Secondary Outcomes

ctDNA levels

Will be associated with Federation of Gynecology and Obstetrics stage and assessed using linear regression, reporting the correlation as well as the model estimates.

Time frame: Baseline

Clinical tumor response

Will be assessed for association with baseline and post-treatment ctDNA using logistic regression. Depending on the number of tumor response, or non-response patients whichever is fewer, multiple variable models may be considered including additional relevant baseline covariates such as disease stage.

Time frame: At post-treatment assessment, assessed up to 2 years

Radiographic tumor response

Time frame: At post-treatment assessment, assessed up to 2 years

Recurrence-free survival

Baseline ctDNA and ctDNA at measured time points will be considered in Cox models.

Time frame: Up to 2 years

Overall survival

Baseline ctDNA and ctDNA at measured time points will be considered in Cox models. ctDNA other than at baseline will be considered in these models as a time dependent covariate. Depending on the number of events, multiple variable models may be considered including additional relevant baseline covariates such as disease stage.

Time frame: Up to 2 years

ctDNA clearance kinetics

Will be correlated with recurrence-free survival. ctDNA other than at baseline will be considered in these models as a time dependent covariate. Depending on the number of events, multiple variable models may be considered including additional relevant baseline covariates such as disease stage.

Time frame: Up to 2 years

ctDNA conversion

Will be correlated during the active monitoring phase with recurrence-free survival.

Time frame: Up to 2 years

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes