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

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Cervical Adenosquamous Carcinoma
Intervention / Treatment

-

Contacts and Locations

Rochester

Mayo Clinic in Rochester, Rochester, Minnesota, United States, 55905

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Able to provide written consent
  • * Patient has given permission to give tumor/blood sample for research testing
  • * Histological confirmation of squamous cell carcinoma or adenosquamous carcinoma
  • * Known HPV status defined as positive staining for p16 on immunohistochemistry (IHC) or DNA in situ hybridization (ISH) for HPV
  • * Willingness to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
  • * Consent to allow blood specimens to be shared with potential external collaborators
  • * Cohort #1: Surgery alone for early stage disease (Federation of Gynecology and Obstetrics \[FIGO\] stage IA-IB1)
  • * FIGO 2019 stage IA1, IA2, IB1
  • * Plan to undergo surgery including but not limited to trachelectomy, radical hysterectomy, and lymph node dissection
  • * Cohort #2: Post-operative radiation +/- chemotherapy for intermediate and high risk factors
  • * Any FIGO stage
  • * Status post any definitive surgical procedure (e.g. radical hysterectomy and lymph node dissection) and on final pathology found to have risk factors:
  • * Intermediate risk: Lymphovascular space invasion (LVSI), deep cervical stromal invasion, tumor size \> 4 cm
  • * High risk: pelvic or para-aortic lymph nodes, parametrial invasion, positive surgical margins
  • * Plan to undergo pelvic +/- para-aortic radiotherapy with or without chemotherapy per standard of care
  • * Cohort #3: 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
  • * Cohort #4: Systemic treatment for recurrent or metastatic disease
  • * Any recurrence (local, regional, or distant) after prior treatment for cervical cancer
  • * Metastases at first diagnosis without prior treatment
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

Allison E. Garda, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

2025-11-30