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出境医 / 临床实验 / Cohabitation Patterns and Incidence of Known and Suspected Sexually Transmitted Diseases

Cohabitation Patterns and Incidence of Known and Suspected Sexually Transmitted Diseases

Study Description
Brief 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 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.


Condition or disease
Cohabitation Patterns Sexually Transmitted Diseases

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 5000000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cohabitation Patterns and Incidence of Known and Suspected Sexually Transmitted Diseases
Actual Study Start Date : April 1, 1968
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. 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).

  2. 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
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.

Criteria

Inclusion Criteria:

  • All citizens in Denmark

Exclusion Criteria:

  • Institutionalized individuals
Contacts and Locations

Sponsors and Collaborators
Aarhus University Hospital
Statens Serum Institut
Investigators
Layout table for investigator information
Principal Investigator: Christian Erikstrup, Professor, Chief Physician Aarhus University Hospital
Tracking Information
First Submitted Date May 6, 2019
First Posted Date May 7, 2019
Last Update Posted Date May 7, 2019
Actual Study Start Date April 1, 1968
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 6, 2019)
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cohabitation Patterns and Incidence of Known and Suspected Sexually Transmitted Diseases
Official Title Cohabitation Patterns and Incidence of Known and Suspected Sexually Transmitted Diseases
Brief 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 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
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.

Condition
  • Cohabitation Patterns
  • Sexually Transmitted Diseases
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 6, 2019)
5000000
Original Actual Enrollment Same as current
Actual Study Completion Date December 31, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All citizens in Denmark

Exclusion Criteria:

  • Institutionalized individuals
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03941158
Other Study ID Numbers 2015-57-0102
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Christian Erikstrup, Aarhus University Hospital
Study Sponsor Aarhus University Hospital
Collaborators Statens Serum Institut
Investigators
Principal Investigator: Christian Erikstrup, Professor, Chief Physician Aarhus University Hospital
PRS Account Aarhus University Hospital
Verification Date May 2019