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This study will evaluate serum vitamin D (25(OH)D) and serum leptin levels at the time of diagnosis of ovarian, primary peritoneal, and/or fallopian tube cancer as well as vitamin D receptor mutation status (FokI SNP genotype). The study will evaluate the impact of vitamin D repletion on serum vitamin D levels, serum leptin levels, and treatment-related morbidity in these patients.
This study will contain 2 cohorts: those with normal serum 25(OH)D and those with low serum 25(OH)D at enrollment. The study will take place in women with ovarian, primary peritoneal, and fallopian tube cancer.
Patients who have given written consent to enroll in the study will have a serum 25(OH)D levels, serum leptin levels, and vitamin D receptor FokI single nucleotide polymorphism analyzed at the time of diagnosis. Patients with vitamin D deficiency will be prescribed vitamin D supplementation according to current guidelines. Treatment with cholecalciferol will not impact cancer therapy. Participants treatment course information will be collected prospectively, but will not be dictated by this study. Serum 25(OH)D and leptin levels will be collected again at the completion of primary therapy, 6 months after the completion of primary therapy, and at the time of disease recurrence. If patients remain vitamin D deficient at any of these follow-up time points, they will be referred to an endocrinologist for further work-up and treatment of their vitamin D deficiency. Data collection will continue for up to 1 year after enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Vitamin D levels will be measured at the time of routine blood work. If Vitamin D levels are found to be low, patients will take 50,000 IU of vitamin D3 weekly daily as maintenance therapy. There is no prospective control arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Drug | Vitamin D3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Related Morbidity | Chemotherapy and 30-day post-operative surgical morbidity will be measured and reported in aggregate as number of patients with chemotherapy-related and/or surgery-related morbidity. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | disease free survival | 1 year |
| Identify serum 25(OH)D and serum leptin relationship | Change in serum 25(OH)D levels with vitamin D repletion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Holman, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 9, 2021 | Dec 7, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 1, 2021 | Dec 7, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| baseline, at completion of primary cancer therapy, at 6 months post-completion of primary therapy, at recurrence or at 1 year post-completion of primary therapy |
| Evaluate serum level changes | Change in serum Leptin levels with vitamin D repletion | baseline, at completion of primary therapy, at 6 months post-completion of primary therapy, at recurrence or at 1 year post-completion of primary therapy] |
| Mutation Status | Vitamin D Receptor FokI Single Nucleotide Polymorphism mutation status | at time of enrollment |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |