NCT03541629

Brief Summary

Objective. The objective of the study is to verify and validate the data collected in the Spanish EURECCA (EUropean REgistry of Cancer CAre) Esophagogastric Cancer Registry between January 2014 and December 2017 through an audit process. It is also intended to describe the initiation and implementation of this Registry as well as its early outcomes. Methods. An audit of registered cases (esophageal, esophagogastric junction and gastric cancer resectable patients undergoing surgery) from 01/01/2014 to 12/31/2017 and a descriptive analysis of these data will be performed. Expected results. The study could show that the Spanish EURECCA Esophagogastric Cancer Registry is a reliable source of information, valid for carrying out specific and exhaustive analysis that may lead to high quality publications in indexed journals. It is also expected to generate a high impact based on the large number of cases included in the Registry, favoring new research projects. Relevance. The standardization of the data collection is essential to compare outcomes between different centers, regions and countries. This study will allows us to verify the integrity of the collected data as well as its accuracy, a critical aspect to gain credibility for future studies using the Registry data.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,839

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Typical duration for all trials

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 26, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

2.4 years

First QC Date

May 17, 2018

Last Update Submit

March 13, 2021

Conditions

Cancer of StomachCancer of Esophagus

Outcome Measures

Primary Outcomes (2)

  • Data integrity

    Determinig the case ascertainment percentage for the Spanish EURECCA Registry

    6 months

  • Data accuracy

    Verification of the accuracy in the collection of 23 selected variables in the Spanish EURECCA Registry for every patient

    6 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population includes all the cases of resectable esophagus, esophagogastric junction and stomach cancer operated in all the hospitals integrated in the Spanish EURECCA Esophagogastric Cancer Registry

You may qualify if:

  • patients diagnosed with esophageal, esophagogastric and gastric cancer candidates for radical resection

You may not qualify if:

  • metastatic patients
  • patients candidates for palliative treatment
  • patients without a signed informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

H. Granollers

Granollers, Barcelona, Spain

Location

C.S. Mataró

Mataró, Barcelona, Spain

Location

H.U. Mútua de Terrassa

Terrassa, Barcelona, Spain

Location

H.U. Sant Joan de Reus

Reus, Tarragona, Spain

Location

H.U. Trias i Pujol

Badalona, Spain

Location

ParcSM

Barcelona, 08003, Spain

Location

H. Parc Taulí

Barcelona, Spain

Location

H. Sant Pau

Barcelona, Spain

Location

H.U. Josep Trueta

Girona, Spain

Location

H.U. Arnau de Vilanova

Lleida, Spain

Location

H.U. Joan XXIII

Tarragona, Spain

Location

Related Publications (14)

  • de Steur WO, Henneman D, Allum WH, Dikken JL, van Sandick JW, Reynolds J, Mariette C, Jensen L, Johansson J, Kolodziejczyk P, Hardwick RH, van de Velde CJ; EURECCA Upper GI Group. Common data items in seven European oesophagogastric cancer surgery registries: towards a European upper GI cancer audit (EURECCA Upper GI). Eur J Surg Oncol. 2014 Mar;40(3):325-9. doi: 10.1016/j.ejso.2013.11.021. Epub 2013 Dec 13.

    PMID: 24412054BACKGROUND

  • Messager M, de Steur WO, van Sandick JW, Reynolds J, Pera M, Mariette C, Hardwick RH, Bastiaannet E, Boelens PG, van deVelde CJ, Allum WH; EURECCA Upper GI Group. Variations among 5 European countries for curative treatment of resectable oesophageal and gastric cancer: A survey from the EURECCA Upper GI Group (EUropean REgistration of Cancer CAre). Eur J Surg Oncol. 2016 Jan;42(1):116-22. doi: 10.1016/j.ejso.2015.09.017. Epub 2015 Sep 30.

    PMID: 26461256BACKGROUND

  • Messager M, de Steur W, Boelens PG, Jensen LS, Mariette C, Reynolds JV, Osorio J, Pera M, Johansson J, Kolodziejczyk P, Roviello F, De Manzoni G, Monig SP, Allum WH; EURECCA Upper GI group (European Registration of Cancer Care). Description and analysis of clinical pathways for oesophago-gastric adenocarcinoma, in 10 European countries (the EURECCA upper gastro intestinal group - European Registration of Cancer Care). Eur J Surg Oncol. 2016 Sep;42(9):1432-47. doi: 10.1016/j.ejso.2016.01.001. Epub 2016 Feb 6.

    PMID: 26898839BACKGROUND

  • Jensen LS, Nielsen H, Mortensen PB, Pilegaard HK, Johnsen SP. Enforcing centralization for gastric cancer in Denmark. Eur J Surg Oncol. 2010 Sep;36 Suppl 1:S50-4. doi: 10.1016/j.ejso.2010.06.025. Epub 2010 Jul 2.

    PMID: 20598495BACKGROUND

  • Kjaer DW, Larsson H, Svendsen LB, Jensen LS. Changes in treatment and outcome of oesophageal cancer in Denmark between 2004 and 2013. Br J Surg. 2017 Sep;104(10):1338-1345. doi: 10.1002/bjs.10586. Epub 2017 Jul 18.

    PMID: 28718940BACKGROUND

  • Linder G, Lindblad M, Djerf P, Elbe P, Johansson J, Lundell L, Hedberg J. Validation of data quality in the Swedish National Register for Oesophageal and Gastric Cancer. Br J Surg. 2016 Sep;103(10):1326-35. doi: 10.1002/bjs.10234. Epub 2016 Jul 28.

    PMID: 27467590BACKGROUND

  • Wouters MW, Jansen-Landheer ML, van de Velde CJ. The Quality of Cancer Care initiative in the Netherlands. Eur J Surg Oncol. 2010 Sep;36 Suppl 1:S3-S13. doi: 10.1016/j.ejso.2010.06.004. Epub 2010 Jun 23.

    PMID: 20576399BACKGROUND

  • Busweiler LA, Wijnhoven BP, van Berge Henegouwen MI, Henneman D, van Grieken NC, Wouters MW, van Hillegersberg R, van Sandick JW; Dutch Upper Gastrointestinal Cancer Audit (DUCA) Group. Early outcomes from the Dutch Upper Gastrointestinal Cancer Audit. Br J Surg. 2016 Dec;103(13):1855-1863. doi: 10.1002/bjs.10303. Epub 2016 Oct 5.

    PMID: 27704530BACKGROUND

  • Allum W, Osorio J. EURECCA oesophago-gastric cancer project. Cir Esp. 2016 May;94(5):255-6. doi: 10.1016/j.ciresp.2015.12.005. Epub 2016 Mar 2. No abstract available. English, Spanish.

    PMID: 26944535BACKGROUND

  • Low DE, Alderson D, Cecconello I, Chang AC, Darling GE, D'Journo XB, Griffin SM, Holscher AH, Hofstetter WL, Jobe BA, Kitagawa Y, Kucharczuk JC, Law SY, Lerut TE, Maynard N, Pera M, Peters JH, Pramesh CS, Reynolds JV, Smithers BM, van Lanschot JJ. International Consensus on Standardization of Data Collection for Complications Associated With Esophagectomy: Esophagectomy Complications Consensus Group (ECCG). Ann Surg. 2015 Aug;262(2):286-94. doi: 10.1097/SLA.0000000000001098.

    PMID: 25607756BACKGROUND

  • Low DE, Kuppusamy MK, Alderson D, Cecconello I, Chang AC, Darling G, Davies A, D'Journo XB, Gisbertz SS, Griffin SM, Hardwick R, Hoelscher A, Hofstetter W, Jobe B, Kitagawa Y, Law S, Mariette C, Maynard N, Morse CR, Nafteux P, Pera M, Pramesh CS, Puig S, Reynolds JV, Schroeder W, Smithers M, Wijnhoven BPL. Benchmarking Complications Associated with Esophagectomy. Ann Surg. 2019 Feb;269(2):291-298. doi: 10.1097/SLA.0000000000002611.

    PMID: 29206677BACKGROUND

  • Bray F, Parkin DM. Evaluation of data quality in the cancer registry: principles and methods. Part I: comparability, validity and timeliness. Eur J Cancer. 2009 Mar;45(5):747-55. doi: 10.1016/j.ejca.2008.11.032. Epub 2008 Dec 29.

    PMID: 19117750BACKGROUND

  • Parkin DM, Bray F. Evaluation of data quality in the cancer registry: principles and methods Part II. Completeness. Eur J Cancer. 2009 Mar;45(5):756-64. doi: 10.1016/j.ejca.2008.11.033. Epub 2009 Jan 6.

    PMID: 19128954BACKGROUND

  • Sakkestad ST, Olsen BC, Karliczek A, Dahl O, Pfeffer F. Validity of Norwegian Rectal Cancer Registry data at a major university hospital 1997-2005. Acta Oncol. 2015 Nov;54(10):1723-8. doi: 10.3109/0284186X.2015.1031913. Epub 2015 Apr 23.

    PMID: 25904461BACKGROUND

MeSH Terms

Conditions

Stomach NeoplasmsEsophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesHead and Neck NeoplasmsEsophageal Diseases

Study Officials

  • Manuel Pera

    Parc de Salut Mar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery, Head of Section of Gastrointestinal Surgery

Study Record Dates

First Submitted

May 17, 2018

First Posted

May 30, 2018

Study Start

July 26, 2018

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

March 16, 2021

Record last verified: 2021-03

Locations

ES(11)