Trial Review

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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
13/10/2021
Date data sharing statement initially provided
28/05/2019
Date results 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
Sex
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
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2001
Date of last participant enrolment
Anticipated
Actual
31/12/2005
Date of last data collection
Anticipated
31/12/2025
Actual
30/04/2021
Sample size
Target
600
Accrual to date
Final
616
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
Country [1] 302746 0
Sweden
Funding source category [2] 302747 0
Charities/Societies/Foundations
Name [2] 302747 0
Swedish Cancer Society
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
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
Trial website
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
[email protected]
Contact person for public queries
Name 93359 0
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
[email protected]
Contact person for scientific queries
Name 93360 0
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
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2043Ethical approval    377575-(Uploaded-10-05-2019-02-33-29)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.