Colorectal CancerNCT03370432
Vitamin D, Genes and Colorectal Cancer
An observational study of Colorectal Cancer, run by University of Southern Denmark.
Trial summary
The aim of this study is to investigate the interaction between intake of vitamin D and polymorphisms in GC and CYP2R1 in relation to risk of colorectal cancer in a Danish prospective cohort study. Read more about this study
- Who is it for?
- Ages 50 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Observational
- How many people
- 2,895 participants
- Where
- No sites listed yet
- Study dates
- Dec 1993to Dec 2017
- Phase
- Observational
- 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 50 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The Diet, Cancer and Health study is an ongoing Danish cohort study designed to investigate the relation between diet, lifestyle and cancer risk. The cohort consists of 57,053 persons, recruited between December 1993 and May 1997. All the subjects were born in Denmark, and the individuals were 50 to 64 years of age and had no previous cancers at study entry. Blood samples, anthropometric measures and questionnaire data on diet and lifestyle were collected at study entry. The present study uses a nested case-cohort design. Follow-up is based on population-based cancer registries. Between 1994 and 31th December 2009, 1038 CRC cases were diagnosed. A sub-cohort of 1857 persons has randomly been selected within the full cohort at time of entry into the cohort.
Who may be able to join
- Born in Denmark
- No previous cancers at study entry
- Age between 50-64
Who cannot join
- Previous or present cancer(s) at study entry
About this study
Official title: Associations Between Genetically Determined Low Vitamin D Level, Vitamin D Intake and Risk of Colorectal Cancer in a Prospective Case-cohort Study in Danes
The aim of this study is to investigate the interaction between intake of vitamin D and polymorphisms in GC and CYP2R1 in relation to risk of colorectal cancer in a Danish prospective cohort study.
Read the detailed description
The association between vitamin D and incidence of colorectal cancer (CRC) has been thoroughly investigated in both observational and experimental studies, but the results are conflicting. Genetic epidemiology is an advantageous alternative to randomized, clinical trials for ethical and economic reasons.
The aim of this study is to investigate whether polymorphisms in GC and CYP2R1 that predicts 25-hydroxycholecalciferol (25(OH)D) concentrations after both ultraviolet B radiation and consumption of vitamin D3-fortified bread and milk in Danes are associated with risk of CRC; and further, to examine whether intake of vitamin D through diet and supplementation alter the risk of CRC.
Data are retrieved from the Danish prospective "Diet, Cancer and Health" study encompassing 57,053 persons which were recruited between 1993 to 1997. Between 1994 and 31th December 2009, 1038 CRC cases has been diagnosed. A sub-cohort of 1857 persons has been randomly selected within the full cohort at time of entry into the cohort. The study design is a nested case-cohort study.
- Conditions
- Colorectal Cancer
- Being tested
- Observational
- Keywords
- Vitamin D, GC, CYP2R1, Gene-environment interaction, prospective case-cohort study, single nucleotide polymorphisms, colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Information on diet, lifestyle, weight, height, medical treatment, environmental exposures, and other socio-economic factors were collected at enrolment using questionnaires and interviews
| Study group | Role | What they receive |
|---|---|---|
| Colorectal cancer cases | 1038 participants diagnosed with colorectal cancer from the Diet, Cancer and Health cohort. Receives: Other: Observational | |
| Sub-cohort members | 1857 persons randomly selected within the full cohort at time of entry into the Diet, Cancer and Health cohort. These participants serve as controls for the colorectal cancer cases. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of colorectal cancer in the DCH cohort
Risk of coloractal cancer compared to healthy sub-cohort members and interaction with Vitamin D metabolizing genes and vitamin D intake
Measured: Between 1994 and 31th December 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study startDec 1993
- Primary completionMay 1997
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,895 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Principal investigator, Vibeke Andersen, University of Southern Denmark
- Investigators
- Vibeke Andersen, MD, PhD, Study director, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370432
- Sponsor's protocol ID
- 19-Dvit
- Status last verified
- Dec 2017
- First submitted
- 6 Dec 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tjonneland A, Olsen A, Boll K, Stripp C, Christensen J, Engholm G, Overvad K. Study design, exposure variables, and socioeconomic determinants of participation in Diet, Cancer and Health: a population-based prospective cohort study of 57,053 men and women in Denmark. Scand J Public Health. 2007;35(4):432-41. doi: 10.1080/14034940601047986.
PubMed 17786808Kopp TI, Vogel U, Andersen V. Associations between common polymorphisms in CYP2R1 and GC, Vitamin D intake and risk of colorectal cancer in a prospective case-cohort study in Danes. PLoS One. 2020 Feb 3;15(2):e0228635. doi: 10.1371/journal.pone.0228635. eCollection 2020.
PubMed 32012190
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Genetically Determined Low Vitamin D Level, Vitamin D Intake and Risk of Colorectal Cancer in a Prospective Case-cohort Study in Danes
- ClinicalTrials.gov ID
- NCT03370432
- Acronym / sponsor ID
- 19-Dvit
- Conditions
- Colorectal Cancer
- Keywords
- Vitamin D, GC, CYP2R1, Gene-environment interaction, prospective case-cohort study, single nucleotide polymorphisms, colorectal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,895 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- Dec 1993 (actual)
- Primary completion
- May 1997 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 12 Dec 2017 (actual)
- 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.
The aim of this study is to investigate the interaction between intake of vitamin D and polymorphisms in GC and CYP2R1 in relation to risk of colorectal cancer in a Danish prospective cohort study.
Detailed description
The association between vitamin D and incidence of colorectal cancer (CRC) has been thoroughly investigated in both observational and experimental studies, but the results are conflicting. Genetic epidemiology is an advantageous alternative to randomized, clinical trials for ethical and economic reasons.
The aim of this study is to investigate whether polymorphisms in GC and CYP2R1 that predicts 25-hydroxycholecalciferol (25(OH)D) concentrations after both ultraviolet B radiation and consumption of vitamin D3-fortified bread and milk in Danes are associated with risk of CRC; and further, to examine whether intake of vitamin D through diet and supplementation alter the risk of CRC.
Data are retrieved from the Danish prospective "Diet, Cancer and Health" study encompassing 57,053 persons which were recruited between 1993 to 1997. Between 1994 and 31th December 2009, 1038 CRC cases has been diagnosed. A sub-cohort of 1857 persons has been randomly selected within the full cohort at time of entry into the cohort. The study design is a nested case-cohort study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colorectal cancer cases | – | Other: Observational1038 participants diagnosed with colorectal cancer from the Diet, Cancer and Health cohort. |
| Sub-cohort members | – | Other: Observational1857 persons randomly selected within the full cohort at time of entry into the Diet, Cancer and Health cohort. These participants serve as controls for the colorectal cancer cases. |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The Diet, Cancer and Health study is an ongoing Danish cohort study designed to investigate the relation between diet, lifestyle and cancer risk. The cohort consists of 57,053 persons, recruited between December 1993 and May 1997. All the subjects were born in Denmark, and the individuals were 50 to 64 years of age and had no previous cancers at study entry. Blood samples, anthropometric measures and questionnaire data on diet and lifestyle were collected at study entry. The present study uses a nested case-cohort design. Follow-up is based on population-based cancer registries. Between 1994 and 31th December 2009, 1038 CRC cases were diagnosed. A sub-cohort of 1857 persons has randomly been selected within the full cohort at time of entry into the cohort.
Key inclusion criteria (3 listed)
- Born in Denmark
- No previous cancers at study entry
- Age between 50-64
Key exclusion criteria (1 listed)
- Previous or present cancer(s) at study entry
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 |
|---|---|---|
| ObservationalInformation on diet, lifestyle, weight, height, medical treatment, environmental exposures, and other socio-economic factors were collected at enrolment using questionnaires and interviews | Other | Colorectal cancer cases, Sub-cohort members |
Primary outcome
Incidence of colorectal cancer in the DCH cohort
Time frame: Between 1994 and 31th December 2009
Risk of coloractal cancer compared to healthy sub-cohort members and interaction with Vitamin D metabolizing genes and vitamin D intake
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 19 Dec 2017.
- Results publication: PubMed 17786808Tjonneland A, Olsen A, Boll K, Stripp C, Christensen J, Engholm G, Overvad K. Study design, exposure variables, and socioeconomic determinants of participation in Diet, Cancer and Health: a population-based prospective cohort study of 57,053 men and women in Denmark. Scand J Public Health. 2007;35(4):432-41. doi: 10.1080/14034940601047986.
- Derived from this study: PubMed 32012190Kopp TI, Vogel U, Andersen V. Associations between common polymorphisms in CYP2R1 and GC, Vitamin D intake and risk of colorectal cancer in a prospective case-cohort study in Danes. PLoS One. 2020 Feb 3;15(2):e0228635. doi: 10.1371/journal.pone.0228635. eCollection 2020.
- Description of the Diet, Cancer and Health cohortLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Vibeke Andersen, MD, PhD study director
University of Southern Denmark
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by University of Southern Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. 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 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of colorectal cancer in the DCH cohort (time frame: Between 1994 and 31th December 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03370432, which also lists 2 linked publications.
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 19 Dec 2017.