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The goal of this study is to estimate how often pelvic fractures occur in women treated with radiation therapy for either newly diagnosed or recurrent cervical, endometrial, or vaginal cancer. The study will also estimate the changes in bone mineral density and the changes in the blood that relate to "bone turnover". High bone turnover can weaken bones and make you more likely to break a bone.
If you agree to take part in this study, the following tests and procedures will be performed before radiation therapy:
At 4 weeks after start of radiation therapy, blood (about 2 to 3 teaspoons) will be drawn to test for bone turnover.
At 3 months, 1 year, and 2 years after you complete radiation:
Length of Study:
You will be off study 2 years after you complete radiation.
After 2 years and for up to 5 years, results of bone density tests or scans of the pelvis that you have outside of this study will be collected.
This is an investigational study.
Up to 300 women will take part in the study. All will be enrolled at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evaluation Group | Bone Mineral Density Test + MRI or CT + Blood Test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT or MRI + Blood Test | Procedure | During routine visits, a magnetic resonance imaging (MRI) scan or a computed tomography (CT) scan. Blood (about 1 tablespoon) will be drawn to test for bone turnover. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Bone Mineral Density (BMD) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of pelvic fractures incidence in women treated with definitive pelvic radiation therapy for cervical, endometrial or vaginal cancer | Within 2 years of treatment completion |
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Inclusion Criteria:
Exclusion Criteria:
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Cervical, endometrial, or vaginal cancer patients who will receive extended field radiation, brachytherapy, or pelvic radiation therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Schmeler, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32125711 | Derived | Salcedo MP, Sood AK, Jhingran A, Eifel PJ, Klopp AH, Iyer RB, Fellman BM, Jimenez C, Schmeler KM. Pelvic fractures and changes in bone mineral density after radiotherapy for cervical, endometrial, and vaginal cancer: A prospective study of 239 women. Cancer. 2020 Jun 1;126(11):2607-2613. doi: 10.1002/cncr.32807. Epub 2020 Mar 3. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| D014625 | Vaginal Neoplasms |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D006403 | Hematologic Tests |
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D019411 | Clinical Laboratory Techniques |
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|
| 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 |
| D014623 | Vaginal Diseases |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |