ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-11-17
Study Completion:2027-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04574635

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to provide written consent
  2. * Patient has given permission to give tumor/blood sample for research testing
  3. * Histological confirmation of adenocarcinoma, adenosquamous, or small cell carcinoma of the cervix
  4. * Known HPV status defined as positive staining for p16 on IHC or DNA ISH for HPV
  5. * 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
  6. * Consent to allow blood specimens to be shared with Mayo Clinic study personnel and potential external collaborators for sample analysis
  7. * Definitive Chemoradiotherapy for Locally Advanced Disease (FIGO Stage IB2-IIIC)
  8. * FIGO 2019 Stage IB2-IIIC or not a surgical candidate
  9. * Plan to undergo definitive chemoradiotherapy including external beam radiotherapy, brachytherapy, and chemotherapy
  1. * Other active malignancy =\< 2 years prior to registration.
  2. * EXCEPTIONS: Non-melanotic skin cancer
  3. * NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for cancer
  4. * Pregnancy or lactation
  5. * Inability on the part of the patient to understand the informed consent to be compliant with the protocol

Contacts and Locations

Principal Investigator

Allison E. Garda, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55455
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Allison E. Garda, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-17
Study Completion Date2027-11-30

Study Record Updates

Study Start Date2020-11-17
Study Completion Date2027-11-30

Terms related to this study

Additional Relevant MeSH Terms

  • 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