Uterine Cervix CancerNCT05462951
Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer
An observational study of Uterine Cervix Cancer, run by Denise Fabian at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cervix Cancer
- What is being tested?
- Standard
- Type of treatment
- Surgery or procedure
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2023to 9 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This is an unblinded phase 0 window-of-opportunity intervention clinical trial to study biomarkers of uterine cervix cancer biology and disease progression in women undergoing cisplatin-based radiochemotherapy for advanced-stage uterine cervix cancer.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Phase 0 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.
- Conditions
- Uterine Cervix Cancer
- Being tested
- Standard
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StandardRadiation
Radiation then brachytherapy
| Study group | Role | What they receive |
|---|---|---|
| Radiochemotherapy followed by brachytherapy | Standard daily radiotherapy plus weekly cisplatin followed by brachytherapy Receives: Radiation: Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker
deoxyribonucleotide levels
Measured: 3 months posttherapy
Biomarker
HPV DNA levels
Measured: 3 months posttherapy
Biomarker
Circulating tumor cell count
Measured: 3 months posttherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start3 Jan 2023
- Primary completion9 Jun 2025
- Study completion9 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervix CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denise Fabian
- Sponsor type
- University, hospital or other
- Collaborators
- UK Radiopharma Alliance
- Responsible party
- Sponsor-investigator, Denise Fabian, University of Kentucky
- Investigators
- Denise Fabian, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462951
- Sponsor's protocol ID
- MCC-22-GYN-09
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2022
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 0 Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer
- ClinicalTrials.gov ID
- NCT05462951
- Acronym / sponsor ID
- MCC-22-GYN-09
- Conditions
- Uterine Cervix Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Denise FabianUniversity, hospital or other
- Collaborators
- UK Radiopharma Alliance
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 9 Jun 2025 (actual)
- Study completion
- 9 Jun 2025 (actual)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiochemotherapy followed by brachytherapy | – | Radiation: StandardStandard daily radiotherapy plus weekly cisplatin followed by brachytherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is an unblinded phase 0 window-of-opportunity intervention clinical trial to study biomarkers of uterine cervix cancer biology and disease progression in women undergoing cisplatin-based radiochemotherapy for advanced-stage uterine cervix cancer.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StandardRadiation then brachytherapy | Radiation | Radiochemotherapy followed by brachytherapy |
Primary outcome
Biomarker
Time frame: 3 months posttherapy
deoxyribonucleotide levels
Biomarker
Time frame: 3 months posttherapy
HPV DNA levels
Biomarker
Time frame: 3 months posttherapy
Circulating tumor cell count
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise Fabian, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Cervix Cancer, run by Denise Fabian at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker (time frame: 3 months posttherapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.