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Trial registered on ANZCTR


Registration number
ACTRN12619000786190
Ethics application status
Approved
Date submitted
10/05/2019
Date registered
28/05/2019
Date last updated
28/05/2019
Date data sharing statement initially provided
28/05/2019
Date results information initially provided
28/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Swedish Oesophageal and Cardia Cancer study
Scientific title
The Swedish Oesophageal and Cardia Cancer study
Secondary ID [1] 298203 0
None
Universal Trial Number (UTN)
Trial acronym
SECC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Esophageal cancer 312792 0
Cardia cancer 312859 0
Condition category
Condition code
Cancer 311290 311290 0 0
Oesophageal (gullet)
Cancer 311358 311358 0 0
Stomach

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Surgery for esophageal cancer in Sweden 2001-2005. Patients are followed prospectively concerning health-related quality of life and symptoms to 2025.
Intervention code [1] 314441 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320033 0
Survival is gathered from the national death register.
Timepoint [1] 320033 0
Patients are assessed at 1 year, 5 years, 10 years and 15 years after treatment.
Secondary outcome [1] 370309 0
Health related quality of life using EORTC QLQ C30, and EORTC QLQ OES18. Composite outcome.
Timepoint [1] 370309 0
measured at 1 year, 5 years, 10 years and 15 years after treatment.
Secondary outcome [2] 370493 0
Gastrointestinal symptoms using validated questionnaire EORTC QLQ OES18.
Timepoint [2] 370493 0
1, 5, 10 and 15 years after treatment.
Secondary outcome [3] 370494 0
Complication of surgery measured from medical records according to a predefined protocol. In the protocol the definitions of the included complications are defined:

-Anastomotic leakage or conduit necrosis (verified with endoscopy or x-ray), Yes/No (reference)
-Mechanic bowel obstruction (verified with x-ray or at laparotomy), Yes/No (reference)
-Re-operation for any cause, Yes/No (reference)
-Pneumonia (verified with x-ray), Yes/No (reference)
-Intraabdominal abscess (verified with x-ray), Yes/No (reference).
-Septicaemia (verified with blood culture), Yes/No (reference).
-Wound infection (symptoms requiring treatment), Yes/No (reference).
Timepoint [3] 370494 0
measured from surgery to 90 days after from medical records.

Eligibility
Key inclusion criteria
Operated for esophageal cancer in Sweden April 2001-December 2005.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
ANCOVA regression models will be used to calculate mean scores differences with 95% confidence interval (CI) with HRQOL scores as outcomes. Cox proportional hazard regression models will be used to assess the association between exposure and mortality after surgery. Kaplan Meyer survival curves will be calculated and log rank test will be tested. All above mentioned regression models will be adjusted for predefined confounders.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21465 0
Sweden
State/province [1] 21465 0
N/A

Funding & Sponsors
Funding source category [1] 302746 0
Charities/Societies/Foundations
Name [1] 302746 0
The Stockholm Cancer Society
Address [1] 302746 0
Radiumhemmet, Box 100
171 76
Stockholm
Sweden
Country [1] 302746 0
Sweden
Funding source category [2] 302747 0
Charities/Societies/Foundations
Name [2] 302747 0
Swedish Cancer Society
Address [2] 302747 0
David Bagares gata 5,
SE- 101 55 Stockholm, Sweden
Country [2] 302747 0
Sweden
Primary sponsor type
University
Name
MMK Karolinska Institutet
Address
Karolinska Institutet; Karolinska Universitetssjukhuset Solna (L1:00), 171 76 Stockholm, Sweden
Country
Sweden
Secondary sponsor category [1] 302678 0
None
Name [1] 302678 0
Address [1] 302678 0
Country [1] 302678 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303346 0
Regional ethic committe Stockholm Sweden
Ethics committee address [1] 303346 0
Etikprövningsmyndigheten
Box 2110
750 02 Uppsala
Ethics committee country [1] 303346 0
Sweden
Date submitted for ethics approval [1] 303346 0
01/01/2001
Approval date [1] 303346 0
01/03/2001
Ethics approval number [1] 303346 0
01-340, 05/1491-32, 2012/712-32

Summary
Brief summary
The Swedish Oesophageal and Cardia Cancer study (SECC) is a Swedish nationwide, prospective and population-based cohort including all patients operated on for oesophageal cancer in Sweden between April 2001 and December 2005 with follow-up until 2017. Detailed clinical data have been prospectively collected, including information about patient- and tumour characteristics, treatment (e.g. surgical procedures, complications) and outcomes (including postoperative complications, overall all-cause mortality, and disease-specific mortality) collected from the medical records. Clinical data were collected according to a predefined study protocol to ensure uniformity; the protocol was developed by experienced oesophageal cancer surgeons in Sweden. HRQOL was measured at 12 months, 5 and 10 years with an ongoing 15-year follow-up using the European Organisation for Research and Treatment of Cancer (EORTC) questionnaires. The EORTC QLQ-C30 measures aspects of HRQOL and symptoms common among cancer patient in general while the EORTC QLQ-OES18 measures symptoms common among esophageal cancer patients. In addition, patients responded to a written study-specific questionnaire concerning body weight, height, including a question about impact on their health (1 “not at all”, 2 “a little”, 3 “quite a bit” and 4 “very much”) by other comorbidities. All questionnaires were used as self-administered questionnaires (delivered by mail) and up to three reminders were sent if required. Collection of HRQOL data was obtained anonymously (patients sent their answers to an unknown central administration and not to the treating department). The all-cause and disease specific mortality was assessed by linkage to the Registry of the Total Population and the Causes of Death Registry, respectively. A total of 616 patients undergoing esophagectomy are recruited in SECC.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93358 0
Prof Jesper Lagergren
Address 93358 0
MMK, Karolinska Institutet; Karolinska Universitetssjukhuset Solna (L1:00), 171 76 Stockholm, Sweden
Country 93358 0
Sweden
Phone 93358 0
+46852480000
Fax 93358 0
Email 93358 0
jesper.lagergren@ki.se
Contact person for public queries
Name 93359 0
Prof Jesper Lagergren
Address 93359 0
MMK, Karolinska Institutet; Karolinska Universitetssjukhuset Solna (L1:00), 171 76 Stockholm, Sweden
Country 93359 0
Sweden
Phone 93359 0
+46852480000
Fax 93359 0
Email 93359 0
jesper.lagergren@ki.se
Contact person for scientific queries
Name 93360 0
Prof Jesper Lagergren
Address 93360 0
MMK, Karolinska Institutet; Karolinska Universitetssjukhuset Solna (L1:00), 171 76 Stockholm, Sweden
Country 93360 0
Sweden
Phone 93360 0
+46852480000
Fax 93360 0
Email 93360 0
jesper.lagergren@ki.se

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will not be publicly shared.
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 2043 0
Ethical approval
Citation [1] 2043 0
Link [1] 2043 0
Email [1] 2043 0
Other [1] 2043 0
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 2044 0
Derogar M, Lagergren P. Health-related quality of life among 5-year survivors of esophageal cancer surgery: a prospective population-based study. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2012;30(4):413-8.
Attachments [1] 2044 0
Publication date and citation/details [2] 2045 0
Derogar M, Orsini N, Sadr-Azodi O, Lagergren P. Influence of major postoperative complications on health-related quality of life among long-term survivors of esophageal cancer surgery. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2012;30(14):1615-9.
Attachments [2] 2045 0
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary