ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

None

Universal Trial Number (UTN)

Trial acronym

SECC

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Esophageal cancer

Cardia cancer

Condition category

Condition code

Cancer

Oesophageal (gullet)

Cancer

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Survival is gathered from the national death register.

Timepoint [1]

Patients are assessed at 1 year, 5 years, 10 years and 15 years after treatment.

Secondary outcome [1]

Health related quality of life using EORTC QLQ C30, and EORTC QLQ OES18. Composite outcome.

Timepoint [1]

measured at 1 year, 5 years, 10 years and 15 years after treatment.

Secondary outcome [2]

Gastrointestinal symptoms using validated questionnaire EORTC QLQ OES18.

Timepoint [2]

1, 5, 10 and 15 years after treatment.

Secondary outcome [3]

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]

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?

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]

Sweden

State/province [1]

N/A

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

The Stockholm Cancer Society

Address [1]

Radiumhemmet, Box 100
171 76
Stockholm
Sweden

Country [1]

Sweden

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Swedish Cancer Society

Address [2]

David Bagares gata 5,
SE- 101 55 Stockholm, Sweden

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Regional ethic committe Stockholm Sweden

Ethics committee address [1]

Etikprövningsmyndigheten
Box 2110
750 02 Uppsala

Ethics committee country [1]

Sweden

Date submitted for ethics approval [1]

01/01/2001

Approval date [1]

01/03/2001

Ethics approval number [1]

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

Prof Jesper Lagergren

Address

MMK, Karolinska Institutet; Karolinska Universitetssjukhuset Solna (L1:00), 171 76 Stockholm, Sweden

Country

Sweden

Phone

+46852480000

Fax

jesper.lagergren@ki.se

Contact person for public queries

Name

Jesper Lagergren

Address

MMK, Karolinska Institutet; Karolinska Universitetssjukhuset Solna (L1:00), 171 76 Stockholm, Sweden

Country

Sweden

Phone

+46852480000

Fax

jesper.lagergren@ki.se

Contact person for scientific queries

Name

Jesper Lagergren

Address

MMK, Karolinska Institutet; Karolinska Universitetssjukhuset Solna (L1:00), 171 76 Stockholm, Sweden

Country

Sweden

Phone

+46852480000

Fax

jesper.lagergren@ki.se

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Data will not be publicly shared.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
2043	Ethical 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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically