NCT07504913

Brief Summary

The main objective of this study is the translation, linguistic adaptation into Spanish, and validation of the Korean quality of life questionnaire KOQUSS-40. This tool will allow us to objectively measure the quality of life of patients in clinical trials.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
505

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started May 2025

Geographic Reach
1 country

6 active sites

Status
recruiting

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

Study Progress79%
May 2025Dec 2026

Study Start

First participant enrolled

May 3, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

March 26, 2026

Last Update Submit

March 26, 2026

Conditions

Stomach NeoplasmsValidation Study

Keywords

Stomach neoplasmsValidation studySurveys and questionnairesQuality of life

Outcome Measures

Primary Outcomes (1)

  • Spanish validation of KOQUSS-40 questionnaire

    The main objective of this study is the translation and linguistic adaptation into Spanish, as well as the validation, of the Korean quality-of-life questionnaire KOQUSS-40, originally developed in the Korean setting (SPQUSS, SPanish QUality of life in Stomach cancer patients Study group). This tool will allow us to objectively measure patients' quality of life in clinical trials.

    At baseline and after 30 days.

Study Arms (1)

Development questionaire group and Validation questionaire group

Eligible participants will be patients who meet the inclusion criteria outlined above, namely: adults aged 18 years or older who have undergone gastric cancer surgery with curative intent, from 1 month postoperatively up to 5 years of follow-up, and who have provided informed consent to participate in the Spanish EURECCA Registry for Esophagogastric Cancer as well as signed the specific informed consent for the SPQUSS-4 study. Exclusion criteria for both the development and validation phases will include patients who do not provide informed consent; those with a history of other malignancies; patients with disseminated gastric cancer or candidates for palliative surgery; and patients who have previously completed any quality-of-life questionnaire related to the diagnosis or treatment of gastric cancer.

Other: Development Questionnaire and Validation Questionnaire

Interventions

Development Questionnaire and Validation QuestionnaireOTHER

The intervention consists of administering the questionnaires at the different phases of the study.

Development questionaire group and Validation questionaire group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study patients will come from the centers that are currently part of the Spanish EURECCA Group for Esophagogastric Cancer (GEECEG) in Spain. The GEECEG was created in 2013 and collects prospective and validated information from all patients operated on for esophagogastric cancer in public hospitals of 8 Autonomous Communities. The registry records 116 variables that cover all the care stages of monitoring and treatment of patients with gastric cancer.

You may qualify if:

  • Patients operated on for gastric cancer with curative intent from 1 month postoperatively up to the last 5 years
  • Adult patients over 18 years old
  • No recurrence of the disease
  • Patients who have given their informed consent to participate in the Spanish EURECCA Registry of Esophagogastric Cancer and have signed the specific consent for the SPQUSS-4 study

You may not qualify if:

  • First 30 days after surgery and/or patients with postoperative complications requiring more than 30 days of hospitalization.
  • Patients who do not give their consent to participate in the study will be excluded.
  • Patients with a history of other neoplasms.
  • Patients with disseminated gastric cancer or candidates for palliative surgery, as well as those patients who do not give their consent to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital Universitario Germans Trias y Pujol

Badalona, Barcelona, 08916, Spain

RECRUITING

Hospital Universitario Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

RECRUITING

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Puerto Real

Puerto Real, Cadiz, 11510, Spain

RECRUITING

Hospital Universitario San Pedro

Logroño, La Rioja, 26006, Spain

RECRUITING

Hospital Universitario Arnau de Vilanova

Lleida, Lleida, 25198, Spain

RECRUITING

Related Publications (1)

  • Eom BW, Lee J, Lee IS, Son YG, Ryu KW, Kim SG, Kim HI, Kim YW, Kong SH, Kwon OK, Park JH, An JY, Kim CH, Suh BJ, Yoon HM, Son MW, Park JY, Park JM, Jeong SH, Yoo MW, Song GJ, Yang HK, Suh YS, Park KB, Ahn SH, Shin DW, Jee YS, Ahn HS, Lee S, Min JS, In H, Kim A, Hur H, Lee HJ; KOrean QUality of life in Stomach cancer patients Study group (KOQUSS). Development and Validation of a Symptom-Focused Quality of Life Questionnaire (KOQUSS-40) for Gastric Cancer Patients after Gastrectomy. Cancer Res Treat. 2021 Jul;53(3):763-772. doi: 10.4143/crt.2020.1270. Epub 2020 Dec 29.

    PMID: 33421981BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Manuel Pera, PhD

    Hospital del Mar de Barcelona

    STUDY DIRECTOR

  • Anna Casajoana

    Hospital del Mar de Barcelona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Gimeno, Data Manager

CONTACT

+34676078897eurecca.geeceg@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant. Esophagogastric and Bariatric Surgery Unit, General and Digestive Surgery Service. Hospital del Mar.

Study Record Dates

First Submitted

March 26, 2026

First Posted

April 1, 2026

Study Start

May 3, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to data protection regulations (e.g., GDPR) and because the informed consent obtained from participants does not include provisions for data sharing.

Locations

ES(6)