Health TrialsbyHealthPanel

European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers

ConditionsHelicobacter Pylori InfectionColorectal CancerGastric Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorUniversity of Latvia

About this trial

The EUGastScreen study is designed as a quality implementation study to explore gastric cancer screening strategies within organised cancer screening frameworks. The study is set to target individuals who are entering the age range for CRC screening, integrating gastric cancer screening into this existing structure.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

age 50 years and above (the actual recruitment age corresponds to the first CRC-screening age in each participating country/region);

Disqualifiers

personal history of gastric cancer;

personal history of colorectal cancer;

successfully screened via national colorectal cancer screening programme;

inability or unwillingness to provide informed consent.

Trial population

National healthcare screening databases will be utilized for selecting study participants. The study population will generally be selected from a pre-defined geographical area to ensure access to necessary study facilities. The following regions have been identified as initial study centres: Original pilot sites Estonia - Tallinn city and Harjumaa municipality; Italy (Marche) - Marche Region - Macerata District; Latvia - Riga city, Jēkabpils region and Aizkraukle, Madona, Varakļāni, Līvāni municipalities; Portugal - North of Portugal, Santo Tirso (Medio Ave Local Health Unit; Barcelos-Esposende Local Health Unit). Additional pilot sites Italy (Bologna) - Emilia-Romagna Region - Bologna District; Lithuania - Vilnius city municipality.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Fecal sample acquisition for Helicobacter pylori stool antigen test

    Diagnostic test

    Participants will be offered to perform Helicobacter pylori (H. pylori) Stool antigen test (SAT) for H. pylori infection identification. SAT may be used after eradication therapy to confirm H. pylori eradication success instead of 13C Urea Breath Test.

  • Upper endoscopy with biopsies

    Diagnostic test

    Upper endoscopy will be offered to participants with positive family history and/or alarm symptoms if such are identified (SAT and FIT negative individuals may not undergo questioning for the presence of alarm symptoms), provided a quality-assured endoscopic procedure has not been performed recently.

  • Colonoscopy with biopsies after bowel cleansing

    Diagnostic test

    Colonoscopy will be offered to participants with positive FIT results, or positive family history, provided a quality-assured endoscopic procedure has not been performed recently; or such participants will be managed within national CRC screening programme.

  • Helicobacter pylori eradication therapy

    Drug

    Helicobacter pylori eradication (antimicrobial) therapy offered to participants with Stool antigen test positive results. The recommended approach for first line treatment is bismuth quadruple therapy for 10-14 days, combined with a high-dose PPI BID. The recommended second line eradication medication: Levofloxacin-based quadruple/triple for 14 days plus high-dose PPI BID.

  • Fecal sample acquisition for Fecal Immunochemical test

    Diagnostic test

    Participants will be offered Fecal Immunochemical test for colorectal cancer screening.

  • Breath sample acquisition for 13C Urea Breath Test

    Diagnostic test

    13C Urea Breath test will be offered to participants at least 4 weeks after Helicobacter pylori eradication therapy end for eradication success control.

Treatment groups

8,000 Participants
are divided into 1 treatment group
Group A: Participants6 interventions

Trial outcomes

Primary outcomes

1

Percentage of invited individuals who return a Stool antigen test (SAT) sample.

Number of invited individuals who return a SAT sample divided by the number invited, multiplied by 100.

Time frame
Within 30 days after test kit distribution, according to site-specific procedures.
2

Percentage of eligible individuals who receive a study invitation

Number of eligible individuals who receive a study invitation divided by the number of eligible individuals identified for invitation, multiplied by 100.

Time frame
During the study recruitment period, up to 12 months.
3

Percentage of stool antigen test (SAT)-positive participants who start Helicobacter pylori Eradication Therapy

Number of SAT-positive participants who start eradication therapy divided by the number of SAT-positive participants, multiplied by 100.

Time frame
From positive SAT result through initiation of eradication therapy, up to 12 months
4

Helicobacter pylori eradication rate

Number of SAT-positive participants offered eradication therapy who have a negative post-treatment confirmatory test (stool antigen test or 13C-urea breath test), divided by the number of SAT-positive participants offered therapy, multiplied by 100.

Time frame
At least 4 weeks after completion of eradication therapy, up to 12 months

Secondary outcomes

1

Percentage of participants who take at least 90% of prescribed eradication therapy

Number of participants who take at least 90% of prescribed doses, divided by the number who start therapy, multiplied by 100.

Time frame
From initiation through completion of eradication therapy (10-14 days)
2

Percentage of referred participants who undergo upper gastrointestinal endoscopy

Number of participants referred for upper gastrointestinal endoscopy who undergo the procedure divided by the number of participants referred for upper gastrointestinal endoscopy, multiplied by 100.

Time frame
Through study completion, an average of 1 year
3

Percentage of participants meeting criteria for referral to upper gastrointestinal endoscopy

Number of participants meeting protocol-defined criteria for referral to upper gastrointestinal endoscopy divided by the number of participants assessed for the applicable referral criteria, multiplied by 100.

Time frame
At initial screening assessment
4

Percentage of returned Stool antigen test (SAT) samples not valid for testing

Number of returned SAT samples rejected as invalid divided by the total number returned, multiplied by 100.

Time frame
Through study completion, an average of 1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Latvia

Lead sponsor

National Institute for Health Development, Estonia

Collaborator

University of Bologna

Collaborator

National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos

Collaborator

Instituto Portugues de Oncologia, Francisco Gentil, Porto

Collaborator

Agenzia Regionale Sanitaria delle Marche

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: