Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04574635

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma, Not Otherwise Specified Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Infiltrating Cervical Carcinoma Metastatic Cervical Carcinoma Neoplasms Neoplasms by Site Recurrent Cervical Carcinoma Stage I Cervical Cancer FIGO 2018 Stage IA Cervical Cancer FIGO 2018 Stage IA1 Cervical Cancer FIGO 2018 Stage IA2 Cervical Cancer FIGO 2018 Stage IB Cervical Cancer FIGO 2018 Stage IB1 Cervical Cancer AJCC v8 Stage IB2 Cervical Cancer FIGO 2018 Stage IB3 Cervical Cancer FIGO 2018 Stage II Cervical Cancer FIGO 2018 Stage IIA Cervical Cancer FIGO 2018 Stage IIA1 Cervical Cancer FIGO 2018 Stage IIA2 Cervical Cancer FIGO 2018 Stage IIB Cervical Cancer FIGO 2018 Stage III Cervical Cancer FIGO 2018 Stage IIIA Cervical Cancer FIGO 2018 Stage IIIB Cervical Cancer FIGO 2018 Stage IIIC Cervical Cancer FIGO 2018 Stage IIIC1 Cervical Cancer FIGO 2018 Stage IIIC2 Cervical Cancer FIGO 2018 Stage IV Cervical Cancer FIGO 2018 Stage IVA Cervical Cancer FIGO 2018 Stage IVB Cervical Cancer FIGO 2018 Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Minnesota, Minneapolis, Minnesota, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of blood samples

Primary outcomes

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

    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)

    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.

Secondary outcomes

  1. ctDNA levels

    Time frame: Baseline

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

  2. Clinical tumor response

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

    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.

  3. Radiographic tumor response

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

    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.

  4. Recurrence-free survival

    Time frame: Up to 2 years

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

  5. Overall survival

    Time frame: Up to 2 years

    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.

  6. ctDNA clearance kinetics

    Time frame: Up to 2 years

    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.

  7. ctDNA conversion

    Time frame: Up to 2 years

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2027
First posted
Oct 5, 2020
Registry last updated
Oct 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.