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Completed

NCT Number: NCT05462951

Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer

This is a phase 0 clinical trial of molecular biomarkers in women with uterine cervix cancer. Women receive standard-of-care radiochemotherapy followed by brachytherapy. Blood samples are obtained to detect circulating levels of deoxyribonucleotides, human papillomavirus DNA, and circulating tumor cells.

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Key information

Conditions

Uterine Cervix Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Markey Cancer Center

Lexington, Kentucky, 40536, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Untreated pathologically or cytologically-confirmed diagnosis of stage IB3 (> 4cm), II, III, or IVA (FIGO 2018) squamous, adenosquamous, or adenocarcinoma of the uterine cervix not amenable to curative surgery alone.

Exclusion criteria

  • Presence of another concurrent active invasive malignancy
  • Prior invasive malignancy diagnosed within the last three years except for [1] non-melanoma skin cancer or [2] prior in situ carcinoma of the cervix
  • prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues at the discretion of the treating physician.

Treatment and study plan

Standard

Radiation

Radiation then brachytherapy

Primary outcomes

  1. Biomarker

    Time frame: 3 months posttherapy

    deoxyribonucleotide levels

  2. Biomarker

    Time frame: 3 months posttherapy

    HPV DNA levels

  3. Biomarker

    Time frame: 3 months posttherapy

    Circulating tumor cell count

Sponsors and collaborators

Lead sponsor

Denise Fabian

Other

Collaborators

  • UK Radiopharma Alliance

Registry information

Official study title

Phase 0 Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 18, 2022
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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