Colorectal Neoplasms MalignantNCT03581890
Socioeconomic Position in Acute Colorectal Cancer Surgery
An observational study of Colorectal Neoplasms Malignant, run by Zealand University Hospital.
Trial summary
Acute colon cancer surgery has a poor 90-day mortality of 21.0% compared with only 3% after elective colorectal cancer surgery in Denmark. The high mortality after acute colon cancer surgery compared with elective surgery emphasizes the importance of identifying factors associated with acute onset and poor short-term… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms Malignant
- What is being tested?
- Socioeconomic position
- How many people
- 35,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2007to 31 Jul 2018
- How long will I take part?
- 1 Year
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population is retracted from the Danish Colorectal Cancer Group (DCCG.dk) database. See description of the database in cohort description. Information regarding highest attained education, age- and sex-adjusted income, cohabitation, and urbanicity will be collected from the registry of education and knowledge, registry of labor, income and wealth, and registry of living conditions via Statistics Denmark, which are nation-wide register with information on health, income, education, family status and other social data from all Danish citizens. From the National Patient Registry we collect data regarding SEMS and diverting stoma in relation to an emergency admission 72 hours before the procedures.
Who may be able to join
- First study
- All patients undergoing a surgical procedure for colorectal cancer in Denmark and registered in the Danish Colorectal Cancer Group (DCCG.dk) database from 1st of January 2007 to 31st of December 2016. If a patient dies during surgery, they will also be included.
- Second study
- All patients operated for acute colorectal cancer in Denmark from 1st of January 2007 to 31st of December 2016 and registered in the DCCG.dk database. Acute surgery can either be colectomy, placement of self-expanding metallic stent, diverting stoma, or damage control surgery. If a patient dies during surgery, they will also be included.
Who cannot join
- Both studies:
- Not registered In the DCCG.dk database with a colorectal cancer diagnose.
- Missing on income, urbanicity, cohabitation, or UICC-stage.
- Second study:
- Registered in the DCCG.dk database with an elective surgical procedure without a registration of SEMS or diverting stoma 72 hours before an emergency admission in NPR.
- lost to follow-up one year postoperative.
About this study
Official title: Is Socioeconomic Position Associated With Acute Onset of Colon Cancer and 1-year Mortality After Acute Colon Cancer Surgery
Acute colon cancer surgery has a poor 90-day mortality of 21.0% compared with only 3% after elective colorectal cancer surgery in Denmark. The high mortality after acute colon cancer surgery compared with elective surgery emphasizes the importance of identifying factors associated with acute onset and poor short-term survival after acute surgery. Socioeconomic position has previously showed to be a risk factor for acute versus elective onset of colorectal cancer. Furthermore, if patients with low socioeconomic position have higher postoperative mortality this could reflect differences in the treatment of patients according to their socioeconomic position.
The aim of the clinical study is:
- To examine if patients with short education, low income, living alone, or living in rural areas are more likely to undergo acute colorectal cancer surgery than elective surgery compared with patients with longer educations, higher income, living with a partner, or living in urban areas.
- To examine if there is an association between education, income, cohabitation, or urbanicity and 1-year mortality after acute colorectal cancer surgery.
Read the detailed description
Hypothesis
The investigators hypothesize that patients with short education, low income, living alone, or living in rural areas are, themselves or their physician, less likely to react to unspecified symptoms of colon cancer and have a higher risk of acute onset due to more progressed disease compared with patients with a higher socioeconomic position. Furthermore, the hypothesis is that there is an association between socioeconomic position and 90-day mortality after acute colorectal surgery, explained by patient, treatment or organizational related factors.
Methods
The study is a nationwide, historical cohort study with prospective collected data. All patients in Denmark will be followed up one year after surgery. Exposure is socioeconomic position measured by highest attained education, age and sex-adjusted income, cohabitation status, and urbanicity. Primary outcome in the first study is acute surgical procedure for colorectal cancer. Primary outcome in the second study is year mortality after acute colorectal cancer surgery or insertion of self-expanding metallic stent (SEMS).
Analysis
First study:
Differences in socioeconomic position between patients undergoing acute and elective CRC surgery will be explored with a logistic regression model. We will include the following covariates in the analysis:
Confounders: age, sex.
Mediators: comorbidity (Charlson Comorbidity Index), BMI (Body Mass Index), alcohol, UICC-stage (The Union for International Cancer Control), smoking, tumor localization, income, education, cohabitation, urbanicity A sensitivity analysis will be conducted to examine if department volume adds to the effect of urbanicity.
Second study:
Differences in socioeconomic position in postoperative 1-year mortality after acute colorectal cancer surgery will be analysed with a cox regression model. We will include the following covariates in the analysis:
Confounders: age, sex.
Mediators: comorbidity (Charlson Comorbidity Index), BMI (Body Mass Index), alcohol, UICC-stage (The Union for International Cancer Control), smoking, tumor localization, income, education, cohabitation, urbanicity A sensitivity analysis will be conducted to examine if department volume adds to the effect of urbanicity.
Ethical considerations
The project has been approved by the Danish Data Protection Agency with journal no. 2015-41- 3726. Data will be handled according to Danish law and the Helsinki declaration. This study does not require written content from the participants, thus all data is retracted from databases and registries.
In the presentation of final results all patients will remain anonymous and not identifiable according to Danish law. All data will be kept a minimum of 5 years.
- Conditions
- Colorectal Neoplasms Malignant
- Being tested
- Socioeconomic position
- Keywords
- Colorectal cancer, Socioeconomic position
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socioeconomic positionOther
Socioeconomic position is the exposure in both study 1 and 2. Four different socioeconomic measures will be tested. The primary socioeconomic position measure is highest attained education the year before surgery (short/medium/long). Secondary measures are:
- age- and sex-adjusted available income the year before surgery
- Cohabitation status at the year of surgery (living alone/living with a partner) at the year of surgery.
- Urbanicity (in four officially, predefined categories).
| Study group | Role | What they receive |
|---|---|---|
| Danish Colorectal Cancer Group (DCCG.dk) database | The DCCG.dk database is a national population-based, clinical database with a completeness proportion of 99% of all colorectal cancer patients in Denmark. Patients are included in the database if treated for or diagnosed with colorectal cancer at a public surgical department in Denmark. No patients underwent treatment for colorectal cancer at private hospitals in Denmark. Metachronous cancers, recurrence, and tumors of other histological origin than primary adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, medullary carcinoma, or undifferentiated carcinoma are not registered in the DCCG.dk database. The surgeon prospectively registers perioperative variables such as surgical priority, stent insertion and type of colectomy, and patient related variables. Information on postoperative mortality is imported to the database from the Danish Central Civil Registration Registry linking all Danish residents with a unique identification number. Receives: Other: Socioeconomic position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute colorectal cancer surgery (study 1)
Acute surgery as the first surgical intervention for colorectal cancer. This is registered by the surgeon in the DCCG.dk database prior to surgery. A surgical procedure is registered as acute by the surgeon based on clinical symptoms of an abdominal crises and how fast the surgical procedure is performed after onset of acute symptoms.
There was no defined time limit from onset of symptoms to onset of procedure in order to classify the procedure as acute. This was up to the surgeon who registered the patient.
Measured: At the time of surgery
Postoperative 1-year mortality rate (study 2)
1-year mortality after acute colorectal cancer surgery
Measured: Within 365 days of surgery
Secondary outcomes (1)
Postoperative 90-day mortality (study 2)
90-day mortality after acute colorectal cancer surgery
Measured: Within 90-days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start1 Dec 2007
- Primary completion31 May 2017
- Study completion31 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Neoplasms MalignantStudies of the same condition, open and under way.
- More trials run by Zealand 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
- Prospective
- Enrolment
- 35,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Sponsor
- Investigators
- Thea H. Degett, MD, Principal investigator, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581890
- Sponsor's protocol ID
- 2015-41-3726
- Status last verified
- Jul 2018
- First submitted
- 22 Mar 2018
- Last updated
- 10 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since the data belongs to the DCCG.dk database, it is not possible to share them.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Socioeconomic Position Associated With Acute Onset of Colon Cancer and 1-year Mortality After Acute Colon Cancer Surgery
- ClinicalTrials.gov ID
- NCT03581890
- Acronym / sponsor ID
- 2015-41-3726
- Conditions
- Colorectal Neoplasms Malignant
- Keywords
- Colorectal cancer, Socioeconomic position
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35,000 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- 1 Dec 2007 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 Jul 2018 (estimated)
- First posted
- 10 Jul 2018 (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.
Acute colon cancer surgery has a poor 90-day mortality of 21.0% compared with only 3% after elective colorectal cancer surgery in Denmark. The high mortality after acute colon cancer surgery compared with elective surgery emphasizes the importance of identifying factors associated with acute onset and poor short-term survival after acute surgery. Socioeconomic position has previously showed to be a risk factor for acute versus elective onset of colorectal cancer. Furthermore, if patients with low socioeconomic position have higher postoperative mortality this could reflect differences in the treatment of patients according to their socioeconomic position.
The aim of the clinical study is:
- To examine if patients with short education, low income, living alone, or living in rural areas are more likely to undergo acute colorectal cancer surgery than elective surgery compared with patients with longer educations, higher income, living with a partner, or living in urban areas.
- To examine if there is an association between education, income, cohabitation, or urbanicity and 1-year mortality after acute colorectal cancer surgery.
Detailed description
Hypothesis
The investigators hypothesize that patients with short education, low income, living alone, or living in rural areas are, themselves or their physician, less likely to react to unspecified symptoms of colon cancer and have a higher risk of acute onset due to more progressed disease compared with patients with a higher socioeconomic position. Furthermore, the hypothesis is that there is an association between socioeconomic position and 90-day mortality after acute colorectal surgery, explained by patient, treatment or organizational related factors.
Methods
The study is a nationwide, historical cohort study with prospective collected data. All patients in Denmark will be followed up one year after surgery. Exposure is socioeconomic position measured by highest attained education, age and sex-adjusted income, cohabitation status, and urbanicity. Primary outcome in the first study is acute surgical procedure for colorectal cancer. Primary outcome in the second study is year mortality after acute colorectal cancer surgery or insertion of self-expanding metallic stent (SEMS).
Analysis
First study:
Differences in socioeconomic position between patients undergoing acute and elective CRC surgery will be explored with a logistic regression model. We will include the following covariates in the analysis:
Confounders: age, sex.
Mediators: comorbidity (Charlson Comorbidity Index), BMI (Body Mass Index), alcohol, UICC-stage (The Union for International Cancer Control), smoking, tumor localization, income, education, cohabitation, urbanicity A sensitivity analysis will be conducted to examine if department volume adds to the effect of urbanicity.
Second study:
Differences in socioeconomic position in postoperative 1-year mortality after acute colorectal cancer surgery will be analysed with a cox regression model. We will include the following covariates in the analysis:
Confounders: age, sex.
Mediators: comorbidity (Charlson Comorbidity Index), BMI (Body Mass Index), alcohol, UICC-stage (The Union for International Cancer Control), smoking, tumor localization, income, education, cohabitation, urbanicity A sensitivity analysis will be conducted to examine if department volume adds to the effect of urbanicity.
Ethical considerations
The project has been approved by the Danish Data Protection Agency with journal no. 2015-41- 3726. Data will be handled according to Danish law and the Helsinki declaration. This study does not require written content from the participants, thus all data is retracted from databases and registries.
In the presentation of final results all patients will remain anonymous and not identifiable according to Danish law. All data will be kept a minimum of 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Danish Colorectal Cancer Group (DCCG.dk) database | – | Other: Socioeconomic positionThe DCCG.dk database is a national population-based, clinical database with a completeness proportion of 99% of all colorectal cancer patients in Denmark. Patients are included in the database if treated for or diagnosed with colorectal cancer at a public surgical department in Denmark. No patients underwent treatment for colorectal cancer at private hospitals in Denmark. Metachronous cancers, recurrence, and tumors of other histological origin than primary adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, medullary carcinoma, or undifferentiated carcinoma are not registered in the DCCG.dk database. The surgeon prospectively registers perioperative variables such as surgical priority, stent insertion and type of colectomy, and patient related variables. Information on postoperative mortality is imported to the database from the Danish Central Civil Registration Registry linking all Danish residents with a unique identification number. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is retracted from the Danish Colorectal Cancer Group (DCCG.dk) database. See description of the database in cohort description. Information regarding highest attained education, age- and sex-adjusted income, cohabitation, and urbanicity will be collected from the registry of education and knowledge, registry of labor, income and wealth, and registry of living conditions via Statistics Denmark, which are nation-wide register with information on health, income, education, family status and other social data from all Danish citizens. From the National Patient Registry we collect data regarding SEMS and diverting stoma in relation to an emergency admission 72 hours before the procedures.
Key inclusion criteria (4 listed)
- First study
- All patients undergoing a surgical procedure for colorectal cancer in Denmark and registered in the Danish Colorectal Cancer Group (DCCG.dk) database from 1st of January 2007 to 31st of December 2016. If a patient dies during surgery, they will also be included.
- Second study
- All patients operated for acute colorectal cancer in Denmark from 1st of January 2007 to 31st of December 2016 and registered in the DCCG.dk database. Acute surgery can either be colectomy, placement of self-expanding metallic stent, diverting stoma, or damage control surgery. If a patient dies during surgery, they will also be included.
Key exclusion criteria (6 listed)
- Not registered In the DCCG.dk database with a colorectal cancer diagnose.
- Missing on income, urbanicity, cohabitation, or UICC-stage.
- Registered in the DCCG.dk database with an elective surgical procedure without a registration of SEMS or diverting stoma 72 hours before an emergency admission in NPR.
- lost to follow-up one year postoperative.
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 |
|---|---|---|
| Socioeconomic positionSocioeconomic position is the exposure in both study 1 and 2. Four different socioeconomic measures will be tested. The primary socioeconomic position measure is highest attained education the year before surgery (short/medium/long). Secondary measures are: 1. age- and sex-adjusted available income the year before surgery 2. Cohabitation status at the year of surgery (living alone/living with a partner) at the year of surgery. 3. Urbanicity (in four officially, predefined categories). | Other | Danish Colorectal Cancer Group (DCCG.dk) database |
Primary outcome
Incidence of acute colorectal cancer surgery (study 1)
Time frame: At the time of surgery
Acute surgery as the first surgical intervention for colorectal cancer. This is registered by the surgeon in the DCCG.dk database prior to surgery. A surgical procedure is registered as acute by the surgeon based on clinical symptoms of an abdominal crises and how fast the surgical procedure is performed after onset of acute symptoms. There was no defined time limit from onset of symptoms to onset of procedure in order to classify the procedure as acute. This was up to the surgeon who registered the patient.
Postoperative 1-year mortality rate (study 2)
Time frame: Within 365 days of surgery
1-year mortality after acute colorectal cancer surgery
1 secondary outcome
Postoperative 90-day mortality (study 2)
Time frame: Within 90-days of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Individual participant dataSharing planned: No. Since the data belongs to the DCCG.dk database, it is not possible to share them.
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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.
Thea H. Degett, MD principal investigator
Zealand University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms Malignant, run by Zealand 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 Jul 2018. 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?
Results are not available in the source record.
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 acute colorectal cancer surgery (study 1) (time frame: At the time of surgery). 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 10 Jul 2018.