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

Overview

Información sobre este estudio

The purpose of this study is to answer whether plasma circulating tumor DNA (ctDNA) obtained by serial analysis before, during, and following surgery, radiotherapy, chemotherapy, and/or immunotherapy for cervical cancer will allow for risk stratification, individualized treatment decision making, monitoring of treatment response, and early detection of residual or recurrent disease in patients presenting with human papillomavirus (HPV) mediated cervical cancer.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Age ≥ 18 years.
  • 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 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 potential external collaborators.
  • 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.

Eligibility last updated 3/24/22. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Allison Garda, M.D.

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publicaciones

Publications are currently not available
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CLS-20508017

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