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

NCT04574635 | Active Not Recruiting

• 3 other identifiers: ROR1905NCI-2020-0696519-011924
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

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.

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; 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

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (7)

• ctDNA levels

  Baseline

• Clinical tumor response

  At post-treatment assessment, assessed up to 2 years

• Radiographic tumor response

  At post-treatment assessment, assessed up to 2 years

• Recurrence-free survival

  Up to 2 years

• Overall survival

  Up to 2 years

Study Arms (1)

Definitive chemoradiotherapy patients

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).

Procedure: Biospecimen Collection

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Definitive chemoradiotherapy patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women ages 18 and older presenting with p16-positive or HPV-positive invasive carcinoma of the cervix cancer with plan to undergo therapy at Mayo Clinic Rochester or the University of Minnesota.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Allison E. Garda, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: October 5, 2020
• Study Start: November 17, 2020
• Primary Completion: September 10, 2025
• Study Completion (Estimated): November 30, 2027
• Last Updated: October 27, 2025

Record last verified: 2025-10

Locations

US (2)