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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervical cancer biopsy | Using tumor biopsies collected before, during, and after radiotherapy, the investigators will:
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| |
| Vaginal apex biopsy | Using vaginal tissue biopsies collected before, during, and after radiotherapy, the investigators will:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brachytherapy | Radiation | Brachytherapy is a cancer treatment where radioactive sources are placed inside or near the tumor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tissue factor expression in tumors | Determine the temporal changes of tissue factor expression in the irradiated tumor immune microenvironment. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with cervical cancer.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jyoti Mayadev, MD | Contact | 858-822-5354 | CancerCTO@health.ucsd.edu | |
| Erika Peterson | Contact | 858-822-5354 | CancerCTO@health.ucsd.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jyoti Mayadev, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | Recruiting | La Jolla | California | 92093 | United States |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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Cervical cancer biopsies and blood collected longitudinally from participants with cervical cancer before, during and after radiotherapy.
Vaginal tissue biopsies and blood collected longitudinally from participants with cervical cancer before, during and after radiotherapy.
|
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |