Clinical trial NCT04574635: Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer
Official title: Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with undetectable circulating tumor deoxyribonucleic acid (ctDNA) posttreatment in patients with detectable ctDNA pre-treatment
timeFrame: 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:
measure: ctDNA levels
timeFrame: Baseline
measure: Clinical tumor response
timeFrame: At post-treatment assessment, assessed up to 2 years
measure: Radiographic tumor response
timeFrame: At post-treatment assessment, assessed up to 2 years
measure: Recurrence-free survival
timeFrame: Up to 2 years
measure: Overall survival
timeFrame: Up to 2 years
measure: ctDNA clearance kinetics
timeFrame: Up to 2 years
measure: ctDNA conversion
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Allison E. Garda, MD
role: PRINCIPAL_INVESTIGATOR
References: