NCT00550563

Brief 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. PURPOSE: This clinical trial is studying changes in DNA that affect vitamin D metabolism in patients with colorectal cancer receiving vitamin D supplements.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Aug 2007

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 30, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

1.7 years

First QC Date

October 25, 2007

Last Update Submit

March 31, 2017

Conditions

Colorectal Cancer

Keywords

recurrent colon cancerstage I colon cancerstage II colon cancerstage III colon cancerstage IV colon cancerrecurrent rectal cancerstage I rectal cancerstage II rectal cancerstage III rectal cancerstage IV rectal cancer

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

Oral Cholecalciferol

EXPERIMENTAL

Patients receive oral cholecalciferol 2000 IU once daily for 1 year

Dietary Supplement: cholecalciferolGenetic: polymerase chain reactionGenetic: polymorphism analysisGenetic: protein expression analysisGenetic: reverse transcriptase-polymerase chain reactionGenetic: western blottingOther: high performance liquid chromatographyOther: laboratory biomarker analysisOther: pharmacological studyProcedure: adjuvant therapyProcedure: immunoscintigraphy

Interventions

cholecalciferolDIETARY_SUPPLEMENT

Oral

Oral Cholecalciferol
polymerase chain reactionGENETIC

companion study

Oral Cholecalciferol
polymorphism analysisGENETIC

companion study

Oral Cholecalciferol
protein expression analysisGENETIC

companion study

Oral Cholecalciferol
reverse transcriptase-polymerase chain reactionGENETIC

companion study

Oral Cholecalciferol
western blottingGENETIC

companion study

Oral Cholecalciferol
high performance liquid chromatographyOTHER

companion study

Oral Cholecalciferol
laboratory biomarker analysisOTHER

companion study

Oral Cholecalciferol
pharmacological studyOTHER

companion study

Oral Cholecalciferol
adjuvant therapyPROCEDURE

Additional therapy

Oral Cholecalciferol
immunoscintigraphyPROCEDURE

additional testing

Oral Cholecalciferol

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

CholecalciferolPolymerase Chain ReactionAmplified Fragment Length Polymorphism AnalysisReverse Transcriptase Polymerase Chain ReactionBlotting, WesternChromatography, High Pressure LiquidChemotherapy, AdjuvantRadioimmunodetection

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsNucleic Acid Amplification TechniquesGenetic TechniquesInvestigative TechniquesDNA FingerprintingElectrophoresisChemistry Techniques, AnalyticalElectrochemical TechniquesImmunoblottingImmunoassayImmunologic TechniquesMolecular Probe TechniquesChromatography, LiquidChromatographyCombined Modality TherapyTherapeuticsDrug TherapyRadionuclide ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Radioisotope

Study Officials

  • Marwan Fakih, MD

    Roswell Park Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2007

First Posted

October 30, 2007

Study Start

August 1, 2007

Primary Completion

April 1, 2009

Study Completion

July 1, 2010

Last Updated

April 4, 2017

Record last verified: 2017-03

Locations

US(1)