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

Mayo Clinic

Status: Active, not recruiting

Conditions: Stage IIIC Cervical Cancer FIGO 2018; Stage III Cervical Cancer FIGO 2018; Stage IV Cervical Cancer FIGO 2018; Stage IIIC2 Cervical Cancer FIGO 2018; Stage IIIB Cervical Cancer FIGO 2018; Recurrent Cervical Carcinoma; Stage IA Cervical Cancer FIGO 2018; Metastatic Cervical Carcinoma; Infiltrating Cervical Carcinoma; Stage IIA Cervical Cancer FIGO 2018; Stage IA1 Cervical Cancer FIGO 2018; Stage IB Cervical Cancer FIGO 2018; Stage IVA Cervical Cancer FIGO 2018; Stage IIB Cervical Cancer FIGO 2018; Stage IB1 Cervical Cancer AJCC v8; Stage IB3 Cervical Cancer FIGO 2018; Stage IIIA Cervical Cancer FIGO 2018; Stage IIA2 Cervical Cancer FIGO 2018; Stage II Cervical Cancer FIGO 2018; Stage IIIC1 Cervical Cancer FIGO 2018; Stage IVB Cervical Cancer FIGO 2018; Stage I Cervical Cancer FIGO 2018; Stage IIA1 Cervical Cancer FIGO 2018; Stage IB2 Cervical Cancer FIGO 2018; Cervical Adenosquamous Carcinoma; Cervical Squamous Cell Carcinoma, Not Otherwise Specified; Stage IA2 Cervical Cancer FIGO 2018

Treatments: Procedure: Biospecimen Collection

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04574635

ROR1905 (Other Identifier)

19-011924 (Other Identifier)

NCI-2020-06965 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

18 participants in 1 patient group

Definitive chemoradiotherapy patients

Description:

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).

Treatment:

Procedure: Biospecimen Collection