Colorectal CancerNCT00550563
DNA Changes That Affect Vitamin D Metabolism in Patients With Colorectal Cancer Receiving Vitamin D Supplements
A study testing cholecalciferol, polymerase chain reaction and polymorphism analysis in people with Colorectal Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- cholecalciferol, polymerase chain reaction and polymorphism analysis
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Prior or current documented diagnosis of colorectal cancer
- All stages
- 25OH-D3 level < 50 ng/mL
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 6 months
- Serum creatinine < 2.0 mg/dL
- Serum bilirubin < 2.0 mg/dL
- No prior or current hypercalcemia (defined as albumin corrected serum calcium < 10.2 mg/dL)
- No known contraindication for vitamin D supplementation
- No genitourinary stones within the past 5 years
- No severe comorbid conditions such as uncompensated heart failure or active infection
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)
- Nondietary vitamin D supplements should not have exceeded 800 IU/day within the past 2 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
About this study
Official title: Identification of 24-Hydroxylase Polymorphisms and Splicing Variants That Modulate Vitamin D Oxidative Metabolism and Serum Pharmacokinetics in Patients With Colorectal Cancer on Cholecalciferol Therapy
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.
Read the detailed description
OBJECTIVES:
- To identify CYP24 single nucleotide polymorphisms (SNPs) using peripheral blood mononuclear cell genomic DNA from patients with colorectal cancer receiving cholecalciferol supplementation.
- To evaluate the effects of these CYP24 SNPs on baseline serum vitamin D_3 metabolites (25-D_3, 24,25-D_3, and 1,25-D_3), and parathyroid hormone levels (PTH).
- To evaluate the effects of these CYP24 SNPs on serum vitamin D_3 metabolites and PTH levels during cholecalciferol treatment.
- To examine CYP24 splicing, protein expression, and enzyme activity at baseline and during cholecalciferol treatment.
- To determine the relationship, if any, between serum cholecalciferol pharmacokinetic parameters and CYP24 SNPs, splicing variants, and enzyme activity.
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).
- Conditions
- Colorectal Cancer
- Being tested
- cholecalciferol, polymerase chain reaction, polymorphism analysis, protein expression analysis, reverse transcriptase-polymerase chain reaction
- Keywords
- recurrent colon cancer, stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer, recurrent rectal cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecalciferolDietary supplement
Oral
polymerase chain reactionGenetic
companion study
polymorphism analysisGenetic
companion study
protein expression analysisGenetic
companion study
reverse transcriptase-polymerase chain reactionGenetic
companion study
western blottingGenetic
companion study
high performance liquid chromatographyOther
companion study
laboratory biomarker analysisOther
companion study
companion study
adjuvant therapyProcedure or surgery
Additional therapy
immunoscintigraphyProcedure or surgery
additional testing
| Study group | Role | What they receive |
|---|---|---|
| Oral Cholecalciferol | Experimental | Patients receive oral cholecalciferol 2000 IU once daily for 1 year Receives: Dietary Supplement: cholecalciferol; Genetic: polymerase chain reaction; Genetic: polymorphism analysis; Genetic: protein expression analysis; Genetic: reverse transcriptase-polymerase chain reaction; Genetic: western blotting; Other: high performance liquid chromatography; Other: laboratory biomarker analysis; Other: pharmacological study; Procedure: adjuvant therapy; Procedure: immunoscintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of CYP24 single nucleotide polymorphisms (SNPs)
Measured: 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)
Measured: At baseline
Effect of CYP24 SNPs on serum vitamin D3 metabolites and PTH levels during cholecalciferol treatment
Measured: Baseline, days 14, 30, 60, 90, 180, 270, 360
CYP24 splicing, protein expression, and enzyme activity at baseline and during cholecalciferol treatment
Measured: Baseline, days 14, 30, 60, 90, 180, 270, 360
Relationship between serum cholecalciferol pharmacokinetic parameters and CYP24 SNPs, splicing variants, and enzyme activity
Measured: Baseline, days 14, 30, 60, 90, 180, 270, 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2007 (estimated)
- Study startAug 2007
- Primary completionApr 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marwan Fakih, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550563
- Sponsor's protocol ID
- I 99207
- Other IDs
- RPCI-I-99207
- Status last verified
- Mar 2017
- First submitted
- 25 Oct 2007
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of 24-Hydroxylase Polymorphisms and Splicing Variants That Modulate Vitamin D Oxidative Metabolism and Serum Pharmacokinetics in Patients With Colorectal Cancer on Cholecalciferol Therapy
- ClinicalTrials.gov ID
- NCT00550563
- Acronym / sponsor ID
- I 99207
- Conditions
- Colorectal Cancer
- Keywords
- recurrent colon cancer, stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer, recurrent rectal cancer, stage I rectal cancer, stage II rectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 30 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- To identify CYP24 single nucleotide polymorphisms (SNPs) using peripheral blood mononuclear cell genomic DNA from patients with colorectal cancer receiving cholecalciferol supplementation.
- To evaluate the effects of these CYP24 SNPs on baseline serum vitamin D_3 metabolites (25-D_3, 24,25-D_3, and 1,25-D_3), and parathyroid hormone levels (PTH).
- To evaluate the effects of these CYP24 SNPs on serum vitamin D_3 metabolites and PTH levels during cholecalciferol treatment.
- To examine CYP24 splicing, protein expression, and enzyme activity at baseline and during cholecalciferol treatment.
- To determine the relationship, if any, between serum cholecalciferol pharmacokinetic parameters and CYP24 SNPs, splicing variants, and enzyme activity.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Cholecalciferol | Experimental | Dietary Supplement: cholecalciferol, Genetic: polymerase chain reaction, Genetic: polymorphism analysis, Genetic: protein expression analysis, Genetic: reverse transcriptase-polymerase chain reaction, Genetic: western blotting, Other: high performance liquid chromatography, Other: laboratory biomarker analysis, Other: pharmacological study, Procedure: adjuvant therapy, Procedure: immunoscintigraphyPatients receive oral cholecalciferol 2000 IU once daily for 1 year |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cholecalciferolOral | Dietary supplement | Oral Cholecalciferol |
| polymerase chain reactioncompanion study | Genetic | Oral Cholecalciferol |
| polymorphism analysiscompanion study | Genetic | Oral Cholecalciferol |
| protein expression analysiscompanion study | Genetic | Oral Cholecalciferol |
| reverse transcriptase-polymerase chain reactioncompanion study | Genetic | Oral Cholecalciferol |
| western blottingcompanion study | Genetic | Oral Cholecalciferol |
| high performance liquid chromatographycompanion study | Other | Oral Cholecalciferol |
| laboratory biomarker analysiscompanion study | Other | Oral Cholecalciferol |
| pharmacological studycompanion study | Other | Oral Cholecalciferol |
| adjuvant therapyAdditional therapy | Procedure or surgery | Oral Cholecalciferol |
| immunoscintigraphyadditional testing | Procedure or surgery | Oral Cholecalciferol |
Primary outcome
Identification of CYP24 single nucleotide polymorphisms (SNPs)
Time frame: 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)
Time frame: At baseline
Effect of CYP24 SNPs on serum vitamin D3 metabolites and PTH levels during cholecalciferol treatment
Time frame: Baseline, days 14, 30, 60, 90, 180, 270, 360
CYP24 splicing, protein expression, and enzyme activity at baseline and during cholecalciferol treatment
Time frame: Baseline, days 14, 30, 60, 90, 180, 270, 360
Relationship between serum cholecalciferol pharmacokinetic parameters and CYP24 SNPs, splicing variants, and enzyme activity
Time frame: Baseline, days 14, 30, 60, 90, 180, 270, 360
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwan Fakih, MD principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cholecalciferol, polymerase chain reaction and polymorphism analysis in people with Colorectal Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of CYP24 single nucleotide polymorphisms (SNPs) (time frame: Baseline, days 14, 30, 60, 90, 180, 270, 360). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.