Cervical CancerNCT07121543
Biological Drivers of Cervical Cancer and Side Effects From Radiation Therapy
An observational study of Cervical Cancer, run by University of California, San Diego at 1 site in United States.
Trial summary
The goal of this observational study is to learn more about the biology of cervical cancer in women who receive radiation therapy for this condition. The main question it aims to answer is: Does radiation therapy alter the expression of tissue factor and other molecules in cervical cancer over time? Participants… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Brachytherapy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2025to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with cervical cancer.
Who may be able to join
- Age 18 years or older
- Pathological diagnosis of cervical cancer
- Scheduled to receive brachytherapy for cervical cancer
Who cannot join
- Pregnancy or lactation
- Inability to provide a tissue sample
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California San Diego
La Jolla, California, 92093
Project Manager, 858-822-5354, CancerCTO@health.ucsd.edu
About this study
Official title: Understanding the Biological Drivers of Cervical Cancer and Side Effects From Radiation Therapy
The goal of this observational study is to learn more about the biology of cervical cancer in women who receive radiation therapy for this condition. The main question it aims to answer is:
Does radiation therapy alter the expression of tissue factor and other molecules in cervical cancer over time?
Participants already scheduled for radiation therapy for cervical cancer as part of their regular medical care will provide blood and biopsies of cervical cancer or of the upper portion of the vagina before, during, and on the last day of radiation therapy.
Read the detailed description
The standard of care treatment for locally advanced cervical cancer is a combination of chemotherapy with cisplatin and radiotherapy. Although patients have improved outcomes with chemo-radiotherapy, tumor recurrence can occur. In addition, combining chemotherapy with radiotherapy increases treatment-related side effects. While breakthroughs in radiotherapy and immunotherapy have resulted in targeted cancer care, chemotherapy given with radiotherapy is a non-targeted approach. Better strategies to treat cervical cancer are needed.
In this study, the investigators will use tissue and blood from patients with cervical cancer to perform translational research. This is necessary to discover molecular pathways that could be targeted in the future with novel agents, such as radiotherapy and immunotherapy, for the treatment of women with cervical cancer.
- Conditions
- Cervical Cancer
- Being tested
- Brachytherapy
- Keywords
- Radiotherapy, Cervical cancer, Translational research, Biomarkers
- 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.
BrachytherapyRadiation
Also called Internal radiation therapy
Brachytherapy is a cancer treatment where radioactive sources are placed inside or near the tumor.
| Study group | Role | What they receive |
|---|---|---|
| Cervical cancer biopsy | Using tumor biopsies collected before, during, and after radiotherapy, the investigators will:
1. Evaluate if irradiation alters tissue factor expression in tumors.
2. Determine the temporal changes of biomarkers in the irradiated tumor immune microenvironment. Receives: Radiation: Brachytherapy | |
| Vaginal apex biopsy | Using vaginal tissue biopsies collected before, during, and after radiotherapy, the investigators will:
1. Evaluate if irradiation alters biomarkers of fibrosis in the vaginal tissue.
2. Determine the temporal changes of inflammatory biomarkers that increases the stenosis molecular cascade in the irradiated tumor immune microenvironment. Receives: Radiation: Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue factor expression in tumors
Determine the temporal changes of tissue factor expression in the irradiated tumor immune microenvironment.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start4 Aug 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jyoti Mayadev, MD, University of California, San Diego
- Investigators
- Jyoti Mayadev, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121543
- Sponsor's protocol ID
- 811012
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Biological Drivers of Cervical Cancer and Side Effects From Radiation Therapy
- ClinicalTrials.gov ID
- NCT07121543
- Acronym / sponsor ID
- 811012
- Conditions
- Cervical Cancer
- Keywords
- Radiotherapy, Cervical cancer, Translational research, Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 13 Aug 2025 (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.
The goal of this observational study is to learn more about the biology of cervical cancer in women who receive radiation therapy for this condition. The main question it aims to answer is:
Does radiation therapy alter the expression of tissue factor and other molecules in cervical cancer over time?
Participants already scheduled for radiation therapy for cervical cancer as part of their regular medical care will provide blood and biopsies of cervical cancer or of the upper portion of the vagina before, during, and on the last day of radiation therapy.
Detailed description
The standard of care treatment for locally advanced cervical cancer is a combination of chemotherapy with cisplatin and radiotherapy. Although patients have improved outcomes with chemo-radiotherapy, tumor recurrence can occur. In addition, combining chemotherapy with radiotherapy increases treatment-related side effects. While breakthroughs in radiotherapy and immunotherapy have resulted in targeted cancer care, chemotherapy given with radiotherapy is a non-targeted approach. Better strategies to treat cervical cancer are needed.
In this study, the investigators will use tissue and blood from patients with cervical cancer to perform translational research. This is necessary to discover molecular pathways that could be targeted in the future with novel agents, such as radiotherapy and immunotherapy, for the treatment of women with cervical cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical cancer biopsy | – | Radiation: BrachytherapyUsing tumor biopsies collected before, during, and after radiotherapy, the investigators will: 1. Evaluate if irradiation alters tissue factor expression in tumors. 2. Determine the temporal changes of biomarkers in the irradiated tumor immune microenvironment. |
| Vaginal apex biopsy | – | Radiation: BrachytherapyUsing vaginal tissue biopsies collected before, during, and after radiotherapy, the investigators will: 1. Evaluate if irradiation alters biomarkers of fibrosis in the vaginal tissue. 2. Determine the temporal changes of inflammatory biomarkers that increases the stenosis molecular cascade in the irradiated tumor immune microenvironment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cervical cancer.
Key inclusion criteria (3 listed)
- Age 18 years or older
- Pathological diagnosis of cervical cancer
- Scheduled to receive brachytherapy for cervical cancer
Key exclusion criteria (2 listed)
- Pregnancy or lactation
- Inability to provide a tissue sample
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 |
|---|---|---|
| BrachytherapyAlso: Internal radiation therapyBrachytherapy is a cancer treatment where radioactive sources are placed inside or near the tumor. | Radiation | Cervical cancer biopsy, Vaginal apex biopsy |
Primary outcome
Tissue factor expression in tumors
Time frame: 8 weeks
Determine the temporal changes of tissue factor expression in the irradiated tumor immune microenvironment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- 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.
Jyoti Mayadev, MD principal investigator
University of California, San Diego
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 Cervical Cancer, run by University of California, San Diego 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 13 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jyoti Mayadev, MD (858-822-5354, CancerCTO@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue factor expression in tumors (time frame: 8 weeks). 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 13 Aug 2025.