Evaluation of the Effect of 25-OH-Vitamin D3 Therapy on 15-Prostaglandin Dehydrogenase Expression in Primary Tumor and Normal Colorectal Mucosa in Patients With Colorectal Cancer
PRIMARY OBJECTIVES:
I. To compare the expression of 15-hydroxyprostaglandin dehydrogenase (PGDH) messenger
ribonucleic acid (mRNA) and protein levels in tumor tissue at baseline and after treatment
with 25-hydroxy (OH)-vitamin D3 (cholecalciferol).
II. To compare the expression of 15-PGDH mRNA and protein levels in normal colorectal mucosa
at baseline and following treatment with 25-OH-vitamin D3.
SECONDARY OBJECTIVES:
I. To compare the expression of cyclooxygenase (COX)-1 and COX-2 mRNA in tumor tissues at
baseline and after treatment with 25-OH-vitamin D3.
II. To compare levels of prostaglandin E2 (PGE2) in tumor tissue at baseline and after
treatment with 25-OH-vitamin D3.
III. To compare the expression of COX-1 and COX-2 mRNA in normal colorectal mucosa at
baseline and after treatment with 25-OH-vitamin D3.
IV. To compare levels of PGE2 in normal colorectal mucosa at baseline and after treatment
with 25-OH-vitamin D3.
V. To evaluate the tolerability of a single 100,000 international unit (IU) dose of
25-OH-vitamin D3.
OUTLINE:
Patients receive cholecalciferol orally (PO) 7 days prior to scheduled surgery or endorectal
ultrasound. Patients are only followed through surgery or endorectal ultrasound. In case of
a vitamin-D-related toxicity, the patient will be followed for resolution of the toxicity,
up to 6 months.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Comparison of the expression of 15-PGDH mRNA and protein levels in tumor tissue
An increase in 15-PGDH expression will be defined as at least a 100% increase in mRNA by real-time reverse transcriptase (RT)-polymerase chain reaction (PCR) compared to baseline. Expression of 15-PGDH protein via ELISA in normal and tumor tissue at baseline and following treatment with vitamin D, as well as the absolute and fold changes will be summarized with descriptive statistics (e.g., mean, median, standard deviation, and interquartile range) and using box plots. In addition, 95% confidence intervals for the mean absolute and fold-changes in 15-PGDH levels will be calculated.
7-14 days after treatment
No
Smitha Krishnamurthi, MD
Principal Investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Federal Government
CASE2210
NCT01403103
April 2012
Name | Location |
---|---|
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland, Ohio 44195 |