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| ID | Type | Description | Link |
|---|---|---|---|
| RPCI-I-99207 |
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RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This clinical trial is studying changes in DNA that affect vitamin D metabolism in patients with colorectal cancer receiving vitamin D supplements.
OBJECTIVES:
OUTLINE: Patients receive oral cholecalciferol 2000 IU once daily for 1 year. Patients without response to vitamin D supplementation (serum 25-D_3 level < 32 ng/mL) by 6 months will have their cholecalciferol dose increased to 4000 IU once daily.
Blood is collected at baseline and on days 14, 30, 60, 90, 180, 270, and 360. Peripheral blood mononuclear cells for CYP24 genotyping, protein expression, enzyme activity, and splicing variants are analyzed by polymerase chain reaction (PCR), western blot, high performance liquid chromatography, and reverse transcriptase PCR, respectively. Serum is analyzed for vitamin D_3 metabolite levels (by radioimmunoassay), calcium (to monitor for hypercalcemia), and parathyroid hormone assays (to measure vitamin D effect).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Cholecalciferol | Experimental | Patients receive oral cholecalciferol 2000 IU once daily for 1 year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cholecalciferol | Dietary Supplement | Oral |
| |
| polymerase chain reaction |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of CYP24 single nucleotide polymorphisms (SNPs) | Baseline, days 14, 30, 60, 90, 180, 270, 360 | |
| Effect of CYP24 SNPs on baseline serum vitamin D3 metabolites (25-D3, 24,25-D3, and 1,25-D3), and parathyroid hormone levels (PTH) | At baseline | |
| Effect of CYP24 SNPs on serum vitamin D3 metabolites and PTH levels during cholecalciferol treatment | Baseline, days 14, 30, 60, 90, 180, 270, 360 | |
| CYP24 splicing, protein expression, and enzyme activity at baseline and during cholecalciferol treatment | Baseline, days 14, 30, 60, 90, 180, 270, 360 | |
| Relationship between serum cholecalciferol pharmacokinetic parameters and CYP24 SNPs, splicing variants, and enzyme activity | Baseline, days 14, 30, 60, 90, 180, 270, 360 |
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DISEASE CHARACTERISTICS:
Prior or current documented diagnosis of colorectal cancer
25OH-D3 level < 50 ng/mL
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No supplemental vitamin D beyond what is provided through the study
At least 2 months since prior vitamin D supplementation exceeding 800 International Units (IU)
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| Name | Affiliation | Role |
|---|---|---|
| Marwan Fakih, MD | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
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| Genetic |
companion study |
|
| polymorphism analysis | Genetic | companion study |
|
| protein expression analysis | Genetic | companion study |
|
| reverse transcriptase-polymerase chain reaction | Genetic | companion study |
|
| western blotting | Genetic | companion study |
|
| high performance liquid chromatography | Other | companion study |
|
| laboratory biomarker analysis | Other | companion study |
|
| pharmacological study | Other | companion study |
|
| adjuvant therapy | Procedure | Additional therapy |
|
| immunoscintigraphy | Procedure | additional testing |
|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D016133 | Polymerase Chain Reaction |
| D054458 | Amplified Fragment Length Polymorphism Analysis |
| D020133 | Reverse Transcriptase Polymerase Chain Reaction |
| D015153 | Blotting, Western |
| D002851 | Chromatography, High Pressure Liquid |
| D017024 | Chemotherapy, Adjuvant |
| D016719 | Radioimmunodetection |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D021141 | Nucleic Acid Amplification Techniques |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D016172 | DNA Fingerprinting |
| D004586 | Electrophoresis |
| D002623 | Chemistry Techniques, Analytical |
| D055664 | Electrochemical Techniques |
| D015151 | Immunoblotting |
| D007118 | Immunoassay |
| D007158 | Immunologic Techniques |
| D015336 | Molecular Probe Techniques |
| D002853 | Chromatography, Liquid |
| D002845 | Chromatography |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011877 | Radionuclide Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003947 | Diagnostic Techniques, Radioisotope |
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