Trial Title:
Swedish Oesophago-Gastric Study
NCT ID:
NCT05540119
Condition:
Oesophageal Cancer
Gastric Cancer
Surgical Treatment
Aetiology
Prognostic Factors
Survival
Prediction
Treatment
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Procedure
Intervention name:
Surgery
Description:
Patients who undergo surgery are separately assessed
Arm group label:
SESS
Arm group label:
SWEGASS
Summary:
The overarching aim of this nationwide Swedish cohort study is to reduce death and
suffering from oesophageal and gastric tumours. This aim can be accomplished by a broad
research approach that aims to identify:
1. Risk factors and preventive actions
2. Early detection
3. Improved treatment
Detailed description:
Swedish OEsophageal and GAstric tumour Study (SOEGAS)
Background Globally, oesophageal and gastric tumours are common with a high mortality.
Oesophageal cancer and gastric cancer combined are often labelled upper gastrointestinal
(GI) cancer. These tumours share many characteristics, including anatomy, risk factors,
treatment and prognosis.
The main known risk factors for adenocarcinoma of the oesophagus and gastro-oesophageal
junction are gastro-oesophageal reflux disease and obesity. The main risk factors for the
other main histological type of oesophageal cancer, squamous cell carcinoma, are tobacco
smoking and alcohol. The strongest known risk factor for gastric cancer is infection with
Helicobacter pylori. Shared risk factors include dietary factors, tobacco smoking and
heredity.
The curative treatment of upper GI cancers builds heavily on demanding surgery, where
most of the oesophagus or stomach is resected. Except for surgery, most tumours are also
treated with pre-operative, and sometimes postoperative, chemotherapy or
chemoradiotherapy (6). The palliative treatment is also very important since the majority
of patients are not eligible for curative treatment.
The survival is poor in patients diagnosed with upper GI cancer. This is mainly explained
by late diagnosis since the symptoms are usually late and aggressive tumour biology, with
early spread and recurrence. If detected early, the prognosis is excellent, but only a
fraction of patients is detected at early tumour stages. The overall 5-year survival in
oesophageal cancer is less than 20% and in gastric cancer it is less than 30% in most
populations, including Sweden. The rate of patients found eligible for curative treatment
including surgery is only 20-35%. Among operated patients the postoperative 5-year
survival is 30-50%. It is crucial to conduct research that can improve the lives also of
palliative patients.
It is of great importance to identify factors that can prevent upper GI cancer. Means to
facilitate the detection at a premalignant or early and curable tumour stage would
improve the prognosis and survivorship. It is also highly relevant to identify factors
that can improve the curative and palliative treatment.
Resources Opportunities Sweden offers internationally unique possibilities to link high
quality registry data with clinical data from medical records, which make up a fantastic
resource for valid research in aetiology, prevention, detection, and treatment of upper
GI cancer. The personal identity numbers assigned to all Swedish residents enables
individual data to be linked.
Experience Our research group has a long track record in addressing risk factors,
preventive measures and treatment of upper GI cancer. The research group contains
expertise in clinics, epidemiology and biostatistics.
Overarching aims
The overarching aim of this research project is to reduce death and suffering from upper
GI cancer. This aim can be accomplished by a broad research approach that aims to
identify:
1. Risk factors and prevention Preventive actions can decrease the incidence of these
tumours.
2. Early detection Early detection provides great opportunities for local treatment
(endoscopic resection). Detection at an early invasive stage before metastases have
occurred also provides good chances of cure, but requires more extensive surgery.
3. Improved treatment The mainstay treatment for cure in upper GI cancer is surgical
resection. The research assessing how the surgery can become optimised is limited.
Specific aims
1. Evaluate the recent incidence trends
These analyses will separately assess differences in incidence over time across
various patient and tumour characteristics, including:
- Sex
- Age
- Tumour stage
- Tumour histology
- Tumour site within the oesophagus or stomach
2. Identify risk factors
- Medications
- Lifestyle factors
- Reproductive factors
- Perinatal factors
- Other diseases and co-morbidities
- Surgical procedures for other indications than upper GI tumours
- Hereditary factors
- Socio-economic factors
- Dental and oral health
- Other factors
3. Identify factors that facilitate early detection
- Lifestyle factors
- Other diseases and co-morbidities
- Hereditary factors
- Socio-economic factors
4. Evaluate trends in prognosis Treatment Curative Surgery Neo-adjuvant therapy
Palliative
Patient characteristics Sex Age BMI Socio-economic factors
Tumour characteristics Stage Histology Site within the oesophagus or stomach
5. Identify factors that can improve prognosis and survivorship
- Tumour characteristics
- Surgical factors
- Neoadjuvant therapy
- Socio-economic factors
- Lifestyle factors
- Other diseases and co-morbidities
- Previous surgical procedures
- Reproductive factors
- Medications
- Dental and oral health
- Other factors
Methods Study cohort The cohort is entitled the Swedish OEsophageal and GAstric tumour
Study (acronym SOEGAS), and will include patients diagnosed with oesophageal or gastric
tumour from year 2000 onwards. The selection of the cohort will be based on a diagnosis
code representing oesophageal or gastric tumours recorded in: Swedish Cancer Registry,
Swedish Patient Registry or Cause of Death Registry.
Data collection
This cohort needs to be linked with additional data for us to be able to evaluate the
specific research aims listed above. The resources and data are needed for all cohort
members:
1. The Swedish Patient Registry ('Patientregistret') since 1987 when this registry
became nationwide complete. This registry is managed by the National Board of Health
and Welfare (SoS by Swedish acronym). These data are needed for evaluation of
surgical procedures, re-operations, and all comorbidities.
2. The Swedish Cancer Registry ('Cancerregistret') since 1958 when this registry was
initiated. This registry is managed by SoS. Detailed data are needed for the
oesophageal or gastric tumours, including date of diagnosis, exact tumour site,
histological type of tumour, and tumour stage. Data are also needed on previous
cancers before the start date of the cohort (year 2000) as well as any concurrent or
later (secondary) tumours.
3. The Swedish Prescribed Drug Registry ('Läkemedelsregistret') since July 2005 when
this registry started. This registry is managed by SoS. We need these data to assess
medications as risk factors for these tumours, to assess how medications influence
the outcomes in patients diagnosed with these tumours, and also to assess
comorbidities.
4. The Swedish Dental Health Registry ('Tandhälsoregistret') since this registry was
started in 2008. This registry is held by SoS. We need these data to assess whether
dental and oral health influences the risk of developing oesophageal and gastric
tumours as well as the prognosis and survivorship in these patients.
5. Swedish Medical Birth Registry ('Medicinska födelseregistret') since it started in
1973. This registry is held by SoS, and from this registry we can assess data on
paternity and other key variables in women who have given birth, e.g. BMI. We also
need data on the children, e.g. gestational age, small for gestational age, large
for gestational age, preterm birth.
6. The Swedish Causes of Death Registry ('Dödsorsaksregistret') since 1st January 2000.
This registry is managed by SoS, and is required to assess date of death and causes
of death. These data are needed for the prognostic studies and also for censoring of
patients no longer at risk of various outcomes under study.
7. The Swedish Multi-Generation Registry ('Flergenerationsregistret') since its start.
This registry is held by SCB, and these data are needed to assess the role of
heredity in the aetiology of these tumours.
8. The Swedish Longitudinal integration database for health insurance and labour market
studies (LISA by Swedish acronym) ('Longitudinell integrationsdatabas för
sjukförsäkrings- och arbetsmarknadsstudier'). This registry is held by SCB and is
needed for data on socio-economic factors, including highest level of education,
cohabitation, civil status, income, country of birth and parental countries of
birth, latest year of immigration and emigration, and place of residence.
9. The Swedish Registry of the Total Population ('Registret över totalbefolkningen')
since 1968. These data are needed to calculate the expected risk of oesophageal and
gastric tumours in the corresponding background population. This registry is also
needed for updated information on civil status, divorce, emigration, immigration,
cohabitation and updated information about date of death.
10. The Swedish Defence Recruitment Agency ('Mönstringsregistret') since its initiation.
We need data on BMI and physical capacity from this registry.
11. Medical records. We need data from the hospitals regarding clinical factors
including tumour stage, treatment, risk factors, and various treatment factors. This
means that we need to have personal identity numbers for all cohort members to be
able to find the relevant medical records.
12. Total population data. Finally, we need data from the Swedish Registry of the Total
Population ('Registret över totalbefolkningen') and the Swedish Cancer Registry from
the entire Swedish population from year 2000 onwards to calculate the expected
incidence and mortality rates in the corresponding background population.
Personal identity numbers and key codes We need the personal identity numbers of the
selected cohort members to retrieve the medical records from the healthcare services. We
also need the National Board of Health and Welfare ('Socialstyrelsen') to keep the key
codes to all cohort members in order for us to ask for up-dates of the cohort regarding
potential needs for additional time, follow-up, cohort size and further data.
Statistical analysis The statistical analysis will be done by one of our senior
biostatisticians employed in the group. All data management and analyses will be done
according to laws and regulations. There will be various statistical methods used and
these need to be tailored for each individual study based on the cohort. However, studies
evaluating risk factors will typically be analysed using multivariable logistic
regression, providing odds ratios and 95% confidence intervals adjusted for potential
confounding factors. Studies evaluating mortality as the outcome will be analysed using
multivariable Cox regression, providing hazard ratios and 95% confidence intervals
adjusted for potential confounding factors.
Statistical power The cohort will be powerful enough to study the main research
questions. We cannot expand the study further while maintaining its high internal
validity. It is already nationwide complete and the study period from 2000 onwards
mirrors a modern era of treatment. Thus, we cannot increase the sample size.
Specific study protocols The study protocol for each study included in this project will
be specified with detailed study protocols before initiated. This project plan does not
allow detailed presentation of all future studies based on the data collection, but it
gives an overview of the topic.
Significance
SOEGAS has all prerequisites to contribute substantially with new knowledge that might
reduce deaths and suffering in oesophageal and gastric tumours on a global scale. All of
the studies included in the project will be based on Swedish data and we have good
reasons to believe that outputs from the project will have a global influence as well.
The quality and the contents of the Swedish registries might have changed over calendar
periods but from 2000 onwards only limited changes have been made, which improves the
quality of the research and facilitates interpretations and reduces various sources of
bias. Taken together, SOEGAS might bring extremely valuable information to an area of
research which is clearly understudied which is the aetiology, prevention and treatment
of tumours of the oesophagus and stomach.
Criteria for eligibility:
Study pop:
All patients with oesophageal or gastric cancer in Sweden from year 2006 onwards are
included in the source cohort, but only those who undergo surgery are included in this
project.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria: Surgery for oesophageal or gastric cancer -
Exclusion Criteria: None
-
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Karolinska Institutet
Address:
City:
Stockholm
Zip:
17177
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Jesper Lagergren
Email:
jesper.lagergren@ki.se
Start date:
May 1, 2017
Completion date:
August 31, 2023
Lead sponsor:
Agency:
Karolinska Institutet
Agency class:
Other
Collaborator:
Agency:
Johannes Asplund
Agency class:
Other
Collaborator:
Agency:
Fredrik Mattsson
Agency class:
Other
Collaborator:
Agency:
Eivind Gottlieb
Agency class:
Other
Collaborator:
Agency:
Wilhelm Leijonmarck
Agency class:
Other
Collaborator:
Agency:
Ivan Ernudd
Agency class:
Other
Collaborator:
Agency:
Ellinor Lundberg
Agency class:
Other
Collaborator:
Agency:
Sheraz Markar
Agency class:
Other
Collaborator:
Agency:
Giola Santoni
Agency class:
Other
Source:
Karolinska Institutet
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05540119
