Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer

Denise Fabian

Status: Enrolling

Conditions: Uterine Cervix Cancer

Treatments: Radiation: Standard

Study type: Interventional

Funder types: Other

Identifiers

NCT05462951

MCC-22-GYN-09

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Radiochemotherapy followed by brachytherapy

Other group

Description:

Standard daily radiotherapy plus weekly cisplatin followed by brachytherapy

Treatment:

Radiation: Standard