Neoplasms

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Neoplasms, Squamous Cell

Uterine Neoplasms

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Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

All Drugs and Chemicals

Immunomodulating Agents

Patients undergo collection of blood samples at baseline prior to surgery, at 6 weeks, 3, 6, and 12 months post-surgery, every 6 months during year 2, and at the time of recurrence (if applicable).

Patients undergo collection of blood samples at baseline prior to the first fraction of radiation, during week 4 of radiotherapy, at 6 weeks, 3, 6, and 12 months post-radiotherapy, every 6 months during year 2, and at the time of recurrence (if applicable).

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).

Patients undergo collection of blood samples at baseline prior to initiation of chemotherapy or immunotherapy, at 4 weeks and 8 weeks after initiation of chemotherapy or immunotherapy, every 3 months during years 1 and 2, and at the time of recurrence (if applicable).

Biospecimen Collection

Clinical Trials Referral Office

Allison E. Garda, M.D.

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.

PRIMARY OBJECTIVES:

I. To estimate the ctDNA detection rate in cervix cancer patients undergoing surgery, radiotherapy, chemotherapy, and/or immunotherapy in the setting of primary, recurrent or metastatic disease.

II. Association of ctDNA baseline levels and clearance kinetics with clinical and radiographic tumor response.

III. To explore the association of detectable ctDNA at each time point with invasive recurrence-free survival and overall survival.

IV. To explore the use of ctDNA for surveillance and detection of disease recurrence.

V. To create a repository for future exploratory studies including analyzing changes in T cell and other immune cell subpopulations during and following therapy for cervix cancer.

OUTLINE: Patients are assigned to 1 of 4 cohorts.

COHORT 1: Patients undergo collection of blood samples at baseline prior to surgery, at 6 weeks, 3, 6, and 12 months post-surgery, every 6 months during year 2, and at the time of recurrence (if applicable).

COHORT 2: Patients undergo collection of blood samples at baseline prior to the first fraction of radiation, during week 4 of radiotherapy, at 6 weeks, 3, 6, and 12 months post-radiotherapy, every 6 months during year 2, and at the time of recurrence (if applicable).

COHORT 3: 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).

COHORT 4: Patients undergo collection of blood samples at baseline prior to initiation of chemotherapy or immunotherapy, at 4 weeks and 8 weeks after initiation of chemotherapy or immunotherapy, every 3 months during years 1 and 2, and at the time of recurrence (if applicable).

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

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.

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

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.

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

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.

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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer	NCT04574635	Cervical Adenos... Cervical Squamo... Infiltrating Ce... Metastatic Cerv... Recurrent Cervi... Stage I Cervica... Stage IA Cervic... Stage IA1 Cervi... Stage IA2 Cervi... Stage IB Cervic... Stage IB1 Cervi... Stage IB2 Cervi... Stage IB3 Cervi... Stage II Cervic... Stage IIA Cervi... Stage IIA1 Cerv... Stage IIA2 Cerv... Stage IIB Cervi... Stage III Cervi... Stage IIIA Cerv... Stage IIIB Cerv... Stage IIIC Cerv... Stage IIIC1 Cer... Stage IIIC2 Cer... Stage IV Cervic... Stage IVA Cervi... Stage IVB Cervi...	Biospecimen Col...	18 Years -	Mayo Clinic
Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer	NCT04574635	Cervical Adenos... Cervical Squamo... Infiltrating Ce... Metastatic Cerv... Recurrent Cervi... Stage I Cervica... Stage IA Cervic... Stage IA1 Cervi... Stage IA2 Cervi... Stage IB Cervic... Stage IB1 Cervi... Stage IB2 Cervi... Stage IB3 Cervi... Stage II Cervic... Stage IIA Cervi... Stage IIA1 Cerv... Stage IIA2 Cerv... Stage IIB Cervi... Stage III Cervi... Stage IIIA Cerv... Stage IIIB Cerv... Stage IIIC Cerv... Stage IIIC1 Cer... Stage IIIC2 Cer... Stage IV Cervic... Stage IVA Cervi... Stage IVB Cervi...	Biospecimen Col...	18 Years -	Mayo Clinic

Spots Global Cancer Trial Database for stage ia1 cervical cancer figo 2018