Cohabitation PatternsNCT03941158
Cohabitation Patterns and Incidence of Known and Suspected Sexually Transmitted Diseases
An observational study of Cohabitation Patterns and Sexually Transmitted Diseases, run by Aarhus University Hospital.
Trial summary
The number of infectious agents associated with risks of malignant hematologic diseases is non-negligible and include both viruses and bacteria. The various organisms affect cancer risk either directly by transforming susceptible cells, through chronic antigenic stimulation or by hampering immune function in other… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cohabitation Patterns, Sexually Transmitted Diseases
- How many people
- 5,000,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 1968to 31 Dec 2018
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: In Denmark, every citizen is registered with a unique identification number in the Civil Registration System. Adult persons (18 years or older) who resided in Denmark for any period between 1 April 1968 and primo 2018 will be identified and linked to national health registers by using the unique identification number. Different living arrangements can be defined by using an address-based algorithm to identify each citizen's complete day-by-day cohabitation or marital status history.
Who may be able to join
- All citizens in Denmark
Who cannot join
- Institutionalized individuals
About this study
The number of infectious agents associated with risks of malignant hematologic diseases is non-negligible and include both viruses and bacteria.
The various organisms affect cancer risk either directly by transforming susceptible cells, through chronic antigenic stimulation or by hampering immune function in other ways conducive of cancer development.
Read more
Suspicion of an infectious cancer origin may arise because of clustering with other conditions (e.g. immune deficiency), specific environments or settings (e.g. geographic locales) or with exposures (e.g. blood transfusions).
In this context, relatively few studies have addressed clustering of diseases among spouses to generate hypotheses about the relative contributions of environmental and genetic factors to the risk of individual cancer types.
As a prelude to such an exercise aiming specifically at malignant hematologic diseases, we will test an algorithm characterising cohabitation patterns in the Danish population to assess the risk of sexually transmitted diseases in analyses of register data.
Such information will also be relevant to current guidelines for blood donor deferral policies. Specifically, because of the so-called precautionary principle all blood donations are extensively tested for infectious agents and transfusion of blood now carries an extremely low risk of transmission of HIV, hepatitis B and C. The residual risk of HIV transmission in Denmark is estimated to 1:10,000,000 transfusions. However, several deferral criteria have existed for years without studies to prove their relevance.
Aim: To compare the incidence of both known and suspected sexually transmitted diseases between different cohabitation patterns in the Danish population.
Perspectives: The study results can be used to leverage changes in deferral rules in the Danish blood banks to accommodate strong wishes from stakeholders to avoid the perceived discrimination of various minorities. The study can thus have important ethical and political consequences.
- Medical subject headings
- Sexually Transmitted Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexually transmitted diseases
The diseases will be identified by using the Danish National Patient Register (NPR). Diagnostic information is based on the International Classification of Diseases, Eight and Tenth Revision (ICD-8 and ICD-10).
Measured: 1977 - 2018
HIV, syphilis, and gonorrhea
HIV, syphilis, and gonorrhea will be identified by registration in the Mandatory disease notification system administrated by Statens Serums Institut (SSI), Denmark.
Measured: 2005 - 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 Apr 1968
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cohabitation PatternsStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,000,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Statens Serum Institut
- Responsible party
- Principal investigator, Christian Erikstrup, Aarhus University Hospital
- Investigators
- Christian Erikstrup, Professor, Chief Physician, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941158
- Sponsor's protocol ID
- 2015-57-0102
- Status last verified
- May 2019
- First submitted
- 6 May 2019
- Last updated
- 7 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohabitation Patterns and Incidence of Known and Suspected Sexually Transmitted Diseases
- ClinicalTrials.gov ID
- NCT03941158
- Acronym / sponsor ID
- 2015-57-0102
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000,000 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Statens Serum Institut
- Study start
- 1 Apr 1968 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 7 May 2019 (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 number of infectious agents associated with risks of malignant hematologic diseases is non-negligible and include both viruses and bacteria.
The various organisms affect cancer risk either directly by transforming susceptible cells, through chronic antigenic stimulation or by hampering immune function in other ways conducive of cancer development.
Suspicion of an infectious cancer origin may arise because of clustering with other conditions (e.g. immune deficiency), specific environments or settings (e.g. geographic locales) or with exposures (e.g. blood transfusions).
In this context, relatively few studies have addressed clustering of diseases among spouses to generate hypotheses about the relative contributions of environmental and genetic factors to the risk of individual cancer types.
As a prelude to such an exercise aiming specifically at malignant hematologic diseases, we will test an algorithm characterising cohabitation patterns in the Danish population to assess the risk of sexually transmitted diseases in analyses of register data.
Such information will also be relevant to current guidelines for blood donor deferral policies. Specifically, because of the so-called precautionary principle all blood donations are extensively tested for infectious agents and transfusion of blood now carries an extremely low risk of transmission of HIV, hepatitis B and C. The residual risk of HIV transmission in Denmark is estimated to 1:10,000,000 transfusions. However, several deferral criteria have existed for years without studies to prove their relevance.
Aim: To compare the incidence of both known and suspected sexually transmitted diseases between different cohabitation patterns in the Danish population.
Perspectives: The study results can be used to leverage changes in deferral rules in the Danish blood banks to accommodate strong wishes from stakeholders to avoid the perceived discrimination of various minorities. The study can thus have important ethical and political consequences.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- In Denmark, every citizen is registered with a unique identification number in the Civil Registration System. Adult persons (18 years or older) who resided in Denmark for any period between 1 April 1968 and primo 2018 will be identified and linked to national health registers by using the unique identification number. Different living arrangements can be defined by using an address-based algorithm to identify each citizen's complete day-by-day cohabitation or marital status history.
Key inclusion criteria (1 listed)
- All citizens in Denmark
Key exclusion criteria (1 listed)
- Institutionalized individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sexually transmitted diseases
Time frame: 1977 - 2018
The diseases will be identified by using the Danish National Patient Register (NPR). Diagnostic information is based on the International Classification of Diseases, Eight and Tenth Revision (ICD-8 and ICD-10).
HIV, syphilis, and gonorrhea
Time frame: 2005 - 2018
HIV, syphilis, and gonorrhea will be identified by registration in the Mandatory disease notification system administrated by Statens Serums Institut (SSI), Denmark.
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 7 May 2019.
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.
Christian Erikstrup, Professor, Chief Physician principal investigator
Aarhus University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cohabitation Patterns and Sexually Transmitted Diseases, run by Aarhus University Hospital.
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 1 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 7 May 2019. 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?
Sexually transmitted diseases (time frame: 1977 - 2018). The study lists 2 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 7 May 2019.