Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, B-Cell, Marginal Zone

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Marginal Zone Lymphoma

B-cell Lymphoma

The prescribed dose will be 30 Gy in 15-20 fractions, unless the orbit is to be treated, in which case the dose will be 24 Gy in 1.5 to 2 Gy fractions.

Daily fractions of 1.5-2.0 Gy will be employed. Treatment will be given 5 days per week with the planned duration of treatment not exceeding 28 days.

Involved Field Radiotherapy

Michael MacManus

This prospective study will test the following hypotheses in patients with stage I-II low grade marginal zone (MZ) lymphoma:

* Involved Field Radiotherapy will produce a complete response rate of \> 90%
* Radiotherapy will be associated with a locoregional progression of \< 20% after 10 years
* Death from MZ lymphoma will occur in \< 40% of patients within 10 years of radiotherapy

This study secondary objectives are:

* To collect information on the prevalence of H. pylori in non-gastric MALT lymphoma
* To estimate rates of acute and late toxicity of radiotherapy

Aims of the study :

* To conduct the first multicentre prospective trial of radiotherapy (RT) in stage I-II Marginal Zone Lymphoma (MZL)
* To prospectively identify causal factors for MZL, including infection and inflammatory disease

This study will be the first large trial of any form of therapy for stage I-II, non-gastric marginal zone lymphoma. There is an enormous deficit in the literature with respect to this fascinating but relatively recently-recognised entity. MZL is commonly associated with underlying inflammatory or infective disorders and it is clear, at least in some cases with infection by organisms called Helicobacter pylori and Chlamydia psitacci, that the inflammatory condition can actually cause the lymphoma. The role of H. pylori infection has not been well studied in non gastric MZL in large prospective studies, despite anecdotal reports of regression of non gastric MZL after H. pylori eradication. There have been reports of responses to doxycycline (antibacterial) therapy in patients with evidence of chlamydial infection (C. psitacci) in MZL of the tissues around the eye. This association has not been well studied in any large prospective study and no long-term data for doxycycline therapy exist. Management of stage I-II MZL is variable and often ad-hoc in Australia, despite significant retrospective evidence to support radiotherapy (RT) as the curative treatment modality of choice. In this TROG/ALLG joint study, 100 patients will be recruited over 5 years. All patients will undergo breath tests or endoscopy to detect H. pylori infection. Ocular MZL specimens will be sent to Italy to test for C. psitacci. Patients will receive highly standardised treatment with RT. This study will definitively document the efficacy and safety of RT in stage I and II non-gastric MZL and will include patients with stage IV disease limited to paired-organs, as this disease shows a tendency to home in exclusively on particular organs, such as salivary glands.

Involved Field Radiotherapy for Non-gastric Marginal Zone Lymphoma

A Prospective Single Arm Trial of Involved Field Radiotherapy Alone for Stage I-II Low Grade Non-gastric Marginal Zone Lymphoma

Australasian Leukaemia and Lymphoma Group

Peter MacCallum Cancer Centre, Australia

Trans Tasman Radiation Oncology Group

Digestive System Diseases

Infections

Symptoms and General Pathology

Stomach Neoplasms

Communicable Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Anti-Infective Agents

All Drugs and Chemicals

Gastrointestinal Agents

Antineoplastic Agents

Metronidazole

Amoxicillin

Anti-Bacterial Agents

Esomeprazole

Levofloxacin

Ofloxacin

Bismuth

Antibiotics, Antitubercular

Clarithromycin

Proton Pump Inhibitors

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Antacids

Anti-Ulcer Agents

H. pylori positive patients who will be treated by bismuth-based quadruple therapy.

Participating centers: KBC Rijeka, Croatia; KBC Zagreb, Croatia; Beacon Hospital, Ireland; Uniwersytet medyczny we Wrocławiu, Poland; UMF Cluj-Napoca, Romania; NIJZ, Slovenia

In case there will be a treatment failure after bismuth-based quadruple therapy, the remaining patients with a positive infection will be referred to a levofloxacin based quadruple therapy.

Participating centers: KBC Rijeka, Croatia; KBC Zagreb, Croatia; Beacon Hospital, Ireland; Uniwersytet medyczny we Wrocławiu, Poland; UMF Cluj-Napoca, Romania; NIJZ, Slovenia

H. pylori positive participants who will offered standard triple therapy.

Participating center: University of Latvia, Latvia

In case there will be a treatment failure after standart triple therapy, the remaining patients with a positive infection will be referred to a second line treatment

Participating center: University of Latvia, Latvia

Participants who are positive with H. pylori will receive bismuth-based quadruple therapy:

Antibiotic 1 - Amoxicillin 4 x 500 mg or Clarithromycin 2 x 400 mg, Antibiotic 2 - Metronidazole 4 x 400 mg, Proton pump inhibitor - Esomeprazole 2 x 40 mg, Colloidal bismuth - Bismuth oxide 4 x 120 mg.

Bismuth-based quadruple therapy

In case there will be a treatment failure after Protocol I is completed, the remaining patients with a positive infection will be referred to a secondary treatment:

Antibiotic 1 - Levofloxacin 1 x 500 mg, Antibiotic 2 - Metronidazole 4 x 400 mg, Proton pump inhibitor - Esomeprazole 2 x 40 mg, Colloidal bismuth - Bismuth oxide 4 x 120 mg.

Levofloxacin-based quadruple therapy

Participants who are positive for H. pylori will receive a standard triple therapy:

Antibiotic 1 - Amoxicillin 2 x 1000 mg, Antibiotic 2 - Clarithromycin 2 x 500 mg, Proton pump inhibitor - Esomeprazole 2 x 40 mg.

Standard triple therapy

Participants with treatment failure will be recommended second line treatment - levofloxacin-based:

Antibiotic 1 - Levofloxacin 2 x 500 mg, Antibiotic 2 - Amoxicillin 2 x 1000 mg, Proton pump inhibitor - Esomeprazole 2 x 40 mg

Levofloxacin-based triple

Principal Investigator of the Study - Bojan Tepeš (National Institute of Public Health, Slovenia), Prof., MD

Tatjana Kofol Bric (National Institute of Public Health, Slovenia), MD

Masa Cavlina Sevo, MD

Mirjana Kalauz, Asst. Prof.

Pave Markos, MD, PhD

Tihomir Bradic, MD

Sandra Milic, MD

Charlene Deane, MB Bch BAO, MSc

Ruth Pilkington, MB BcH BAO

Colm O Morain, MD, MB BcH BAO, FRCPI

Orlaith Kelly, PHD, MB BcH

Charlene Deane, MB Bch BAO, MSc, MRCP

Marcis Leja, MD, PhD

Danute Razuka Ebela, MD, PhD

Linda Mezmale, MD

Katarzyna Malinowska

Elzbieta Olejnik

Katarzyna Neubauer, MD, PhD, Assoc. Prof.

Radoslaw Kempinski, MD, PhD

Dan Lucian Dumitrascu, Prof

Radu Farcas, MD, PhD student

Mitja Oblak, MSc

Tatjana Kofol, MD

Bojan Tepeš, prof., MD

Gastric cancer remains a major challenge to public health on a global scale. H. pylori related cancer burden contributes to the largest proportion of cancer cases attributable to infections in Europe. Considering its absolute burden and persisting disparities, in addition to the substantial prevalence of H. pylori infection worldwide that is treatable, gastric cancer is a logical target for urgent action for prevention. Population-based H. pylori test-and-treat has therefore been proposed as a strategy for gastric cancer prevention. To fill the gaps in knowledge about gastric cancer prevention through H. pylori screening and eradication in younger adults, a study of a population-based H. pylori test-and-treat strategy in Ireland, Croatia, Latvia, Poland, Romania and Slovenia.

Main goals of this study are to assess future program processes, feasibility, acceptability and effectiveness. In total of 6,800 adults aged 30-34 will be tested for H. pylori infection. They will be randomly selected to represent the chosen population and invited to participate in the study based on informed consent. Confirmed infections will be treated by available combined therapy in line with treatment guidelines and the success of eradication will be retested during a control check-up.

Patients who will provide their consent to participate will undertake an interview about the risk factors in early childhood and their habits regarding alcohol consumption and use of tobacco. Compliance to testing and treatment, treatment results, adverse effects and reasons for dropping out will be additionally monitored. Gathered data will be analysed in alignment with our research questions. The investigators will disseminate reports and present the results to both the general public and the scientific community in order to foster future developments in gastric cancer prevention.

The main objective of this study is to assess the feasibility of population-based H. pylori test-and-treat strategy for gastric cancer prevention in Europe. The study will allow to assess the feasibility of implementing H. pylori test-and-treat program in an early 30's age group at the population level, which will be carried out for the first time in Europe. This will come with scientifically valid assessment of programme processes, acceptance, effectiveness and possible adverse consequences.

The assessment of predefined quality indicators and achievements of each project task will consequently allow us to scale up the project to the national level, for example, by instituting a national program for gastric cancer prevention with population-based H. pylori test-and-treat program in the asymptomatic population around 30 years of age in different EU countries. The implementation of this strategy as a national program could result in significantly reduced gastric cancer incidence, disease burden and costs of other H. pylori-related diseases in the medium and long term in Slovenia and other participating countries, thus serving as a model for the implementation of this strategy in Europe.

The results of the study can help to guide other EU countries with intermediate and high gastric cancer incidence when implementing similar strategies. The results can also help to guide EU countries with low gastric cancer incidence when implementing similar programs for their subpopulations at risk (e.g. family members of patients with gastric cancer and immigrants from countries with high H. pylori infection and gastric cancer incidence). If implemented in a young adult population, the program can prevent further spread of H. pylori infection by curing the infection before or when they have just started their own families, therefore reducing the risk of intrafamilial transmission.

As shown in previously published economic evaluations of the strategy, the program is not only cost-effective in gastric cancer prevention but also in other high-risk areas. Besides that, H. pylori eradication will also prevent other serious clinical complications, such as peptic ulcers, dyspepsia, primary immune thrombocytopenia and anaemia caused by H. pylori infection.

In total, seven research centers from different European countries participate in the study - Croatia, Ireland, Latvia, Poland, Romania, and Slovenia. A predefined population of young people between 30 to 34 years of age will be invited to participate in the study. Based on signed informed consent they will be offered testing for H. pylori infection.

Acceptability and participation rate of the H. pylori test-and-treat strategy, the prevalence of H. pylori infection in the population of young adults, compliance with the 14-days treatment scheme, the eradication rate, and any adverse effects of the treatment in the population will be thoroughly assessed. Testing and treatment procedure will be substantiated with data about early childhood risk factors for H. pylori infection and the use of tobacco and alcohol consumption. Method used for capturing the participants' self-reported data will be a questionnaire administered by a health professional or self-administered by the patient.

Each center has its own specific research design:

1. Clinical Hospital Center Rijeka (KBC Rijeka), Croatia: 13C-urea breath test (UBT) confirmatory testing combined with H. pylori serology will be determined. H. pylori positive patients will be treated by bismuth-based quadruple therapy (Protocol I):

   • Protocol I with penicillin includes the following medications: Antibiotic 1 - Amoxicillin 4 x 500 mg or Clarithromycin 2 x 400 mg, Antibiotic 2 - Metronidazole 4 x 400 mg, Proton pump inhibitor - Esomeprazole 2 x 40 mg, Colloidal bismuth - Bismuth oxide 4 x 120 mg.

   In case there will be a treatment failure after Protocol I is completed, the remaining patients with a positive infection will be referred to a secondary treatment (Protocol II):

   • Protocol II includes the following medications: Antibiotic 1 - Levofloxacin 1 x 500 mg, Antibiotic 2 - Metronidazole 4 x 400 mg, Proton pump inhibitor - Esomeprazole 2 x 40 mg, Colloidal bismuth - Bismuth oxide 4 x 120 mg. All medications included in Protocol I or Protocol II will be taken orally for 14 consecutive days. After Protocol II is completed, the remaining patients with persisting infection will be treated by gastroenterologist according clinical practice guidelines.
2. University Hospital Centre Zagreb (KBC Zagreb), Croatia: 13C-urea breath test (UBT) confirmatory testing will be determined. In case of positive results participants will be treated with bismuth-based quadruple therapy (Protocol I). One month following the treatment a control UBT will be performed in order to confirm eradication. In case of treatment failure participants will be treated with second-line treatment (Protocol II).
3. Beacon Hospital, Ireland: H. pylori serology with high sensitivity will be offered to participants. For participants with positive serology test results, an additional UBT confirmatory testing will be the second step to confirm an active infection. H. pylori positive patients will be treated by bismuth-based quadruple therapy (Protocol I). One month after conclusion of the treatment a control UBT will be used to confirm eradication. Patients with treatment failure will be treated with an additional second protocol (Protocol II) according to local recommendations.
4. University of Latvia, Latvia: participants will be tested for H. pylori infection by UBT. H. pylori positive participants will be offered standard triple therapy for 14 days as the first-line therapy:

   Antibiotic 1 - Amoxicillin 2 x 1000 mg, Antibiotic 2 - Clarithromycin 2 x 500 mg, Proton pump inhibitor - Esomeprazole 2 x 40 mg.

   At least 30 days after the treatment participants will be retested for H. pylori by UBT to confirm eradication. Participants with treatment failure will be recommended second line treatment - levofloxacin-based:

   Antibiotic 1 - Levofloxacin 2 x 500 mg, Antibiotic 2 - Amoxicillin 2 x 1000 mg, Proton pump inhibitor - Esomeprazole 2 x 40 mg

   Or Pylera based:

   Antibiotic 1 - Metronidazole 4 x 125 mg Antibiotic 2 - Tetracycline 4 x 125 mg Colloidal bismuth - Bismuth Subcitrate Potassium 4 x 140 mg Proton pump inhibitor - Esomeprazole 2 x 40 mg
5. Uniwersytet medyczny we Wrocławiu, Poland: participants will be tested for H. pylori infection by locally validated H. pylori serology test. In case of a positive result the UBT will be performed for confirmation. Positive patients will be treated with bismuth-based quadruple therapy (Protocol I) followed by control UBT in order to confirm eradication. Treatment failure participants will be treated with second line treatment (Protocol II).
6. Iuliu Hațieganu University of Medicine and Pharmacy (UMF), Romania: Locally validated H. pylori serology with high sensitivity will be offered to participants. For participants with positive serology test results, additional UBT confirmatory testing will be the second step to confirm an active infection. H. pylori positive patients with be treated by bismuth-based quadruple therapy (Protocol I). One month after conclusion of the treatment a control UBT will be used to confirm eradication. Patients with treatment failure will be treated with additional second protocol (Protocol II) according to local recommendations.
7. National Institute of Public Health (NIJZ), Slovenia: Locally validated H. pylori serology with high sensitivity will be offered to participants. For participants with positive serology test results, additional UBT confirmatory testing will be the second step to confirm an active infection. H. pylori positive patients with be treated by bismuth-based quadruple therapy (Protocol I). One month after the conclusion of the treatment a control UBT will be used to confirm eradication. Patients with treatment failure will be treated with an additional second protocol (Protocol II) according to local recommendations.

The study will be conducted, commencing in 2024 and concluding in 2026. This timeframe has been chosen to allow for participant recruitment, conducting the study and data analysis for a thorough assessment of the feasibility of the proposed screening strategy.

H. Pylori Screen-and-treat Study in a Population of Young Adults

Multicentric Transnational H. Pylori Screen-and-treat Study in a Population of Young Adults

Responses to qualitative questions and summary statistics from a post-enrollment questionnaire for healthcare workers involved into the implementation of the screening program.

Subtraction of 1) participants who were subjected to treatment failure of the primary therapy regimen from 2) all participants with an active H. pylori infection who underwent the quadruple therapy regimen.

Qualitative records of all self-reported (or physician-reported) adverse events during and after primary (or secondary) eradication therapy regimen. All non-serious or serious adverse event will be reported.

a) completion of the enrollment process (points a)-d)); b) completion of the prospective study (points e)-h)).

Subtraction of 1) study participants who:

1. did not respond to an invitation,
2. signed the informed consent form but were not included in the study due to exclusion criteria,
3. declined to take a serology test,
4. declined to take any of the UBTs as specified in the study protocol,
5. had their therapy postponed due to maternity reasons,
6. declined to be re-treated after the treatment failure of primary therapy,
7. voluntarily withdrew at any time during their participation in the study,
8. withdrew from the study within points a)-g) combined, from 2) all participants invited in the study.

The participation rate is measured in frequencies and percentage points (%).

Clinical Hospital Center Rijeka

Clinical Hospital Centre Zagreb

Beacon Hospital

Wroclaw Medical University

Iuliu Hatieganu University of Medicine and Pharmacy

National Institute of Public Health, Slovenia

University of Latvia

Helicobacter Infections

Bacterial Infections

Gram-Negative Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies;

a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability

a health systems-level intervention using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies

Test-and-treat EHR-CHW intervention

a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability.

Usual care of EHR-only intervention

Simona Kwon, DrPH,MPH

This study will assess the efficacy, adoption, and impact of an integrated intervention to improve adherence to recommended stomach cancer prevention guidelines (H. pylori test-and-treat) for at-risk Chinese Americans in NYC. The integrated multifaceted theory-based intervention involves: 1) a health systems-level intervention using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies; and 2) a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability. Using a 2-arm randomized controlled trial (RCT) design, \> 144 Chinese American patients across NYC safety net hospital endoscopy clinics and primary health centers will participate.

Patient-Centered Cancer Prevention In Chinese Americans

Measured using breath ammonia measurement, fecal stool antigen test or other clinically approved H. pylori infection diagnostic test. Data extracted from patient EHR.

11- item assessment of participant's confidence in making an informed choice. For each item, confidence is rated on a 5-point Likert scale from 0 (not at all confident) to 4 (very confident). The total score is the sum of responses and ranges from 0 to 44; higher scores indicate greater decision self-efficacy.

"The MARS-5 is a 5-item self-assessment of medication adherence. The first item assesses unintentional non-adherence, while the four other items assess intentional non-adherence. Participants indicated how often each statement applied to them in the past month on a 5-point Likert scale (1=always, 2=often, 3=sometimes, 4=rarely, 5=never), resulting in a total score ranging from 5 to 25. Non-adherence is defined as reporting any non-adherence on the MARS (total score \<25). Adherence is defined as a score of 25."

National Institute on Minority Health and Health Disparities (NIMHD)

NYU Langone Health

Carbamide Peroxide

H. pylori diagnostic test: C13 urea breath test

H. pylori diagnostic test: H. pylori stool antigen test

HPSA

H. pylori diagnostic tests: H. pylori serology test, C13 urea breath test

UBT and HPSA

H. pylori diagnostic test: H. pylori serology test

Serology (two stage)

Jyh-Ming Liou, MD,PhD

There are still some unsolved questions regarding population-based screening program for H. pylori infection to prevent gastric cancer, such as how to perform the optimal screening strategies. A prospective, randomized trial will be conducted to compare the acceptability, compliance (/adherence), and accuracy of diagnostic tests in a population-based H. pylori screening and gastric cancer prevention program. The investigators will recruit 10,000 adults with age of ≥20 years who have not received H. pylori screening or treatment. Eligible patients will be randomly 1:1:1:1 allocated to four groups with different combination tests.

Background: There are still some unsolved questions regarding population-based screening program for H. pylori infection to prevent gastric cancer, such as how to perform the optimal screening strategies.

Objective: A prospective, randomized trial will be conducted to compare the acceptability, compliance (/adherence), and accuracy of C13 UBT and HpSA in a population-based H. pylori screening and gastric cancer prevention program.

Methods：Open labeled, randomized controlled trial The investigators will recruit 10,000 adults with age of ≥20 years who have not received H. pylori screening or treatment. Eligible patients will be randomly 1:1:1:1 allocated to (A) The carbon-13 urea breath test (C13 UBT), (B) H. pylori stool antigen test (Vstrip® HpSA), (C) Both C13 UBT and HpSA, (D) Two-stage screening method (serology screening only, and then C13 UBT for confirmation if serology test is positive).

Outcome analysis:

1. Detection rate of H. pylori infection
2. To compare the compliance(/adherence) of screening tests for H. pylori infection in the two randomized groups.
3. To assess the diagnostic accuracy of these tests.
4. To verify the compliance(/adherence) and feasibility of this two-stage screening method
5. Long-term Outcomes: To assess the risk reduction of gastric cancer

Screening Strategy for Gastric Cancer Prevention

Identification of the Optimal Screening Strategy for Gastric Cancer Prevention

The positivity rate of H. pylori infection between different study arms, respectively in ITT and PP analysis.

Completion rates of the study (from enrollment to the diagnosis of H. pylori; from enrollment to the treatment of H. pylori infection.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Involved Field Radiotherapy for Non-gastric Marginal Zone Lymphoma	NCT00377195	Non-gastric Mar...	Involved Field ...	18 Years -	Trans Tasman Radiation Oncology Group
H. Pylori Screen-and-treat Study in a Population of Young Adults	NCT06275204	Gastric Cancer H Pylori Infect... H Pylori Eradic... H-pylori	Bismuth-based q... Levofloxacin-ba... Standard triple... Levofloxacin-ba...	30 Years - 34 Years	University of Latvia
Patient-Centered Cancer Prevention In Chinese Americans	NCT03340454	H. Pylori Infec...	Test-and-treat ... Usual care of E...	21 Years -	NYU Langone Health
Involved Field Radiotherapy for Non-gastric Marginal Zone Lymphoma	NCT00377195	Non-gastric Mar...	Involved Field ...	18 Years -	Trans Tasman Radiation Oncology Group
Screening Strategy for Gastric Cancer Prevention	NCT05387005	H. Pylori Infec...	UBT HPSA UBT and HPSA Serology (two s...	20 Years -	National Taiwan University Hospital

Spots Global Cancer Trial Database for h. pylori

Every month we try and update this database with for h. pylori cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for h. pylori

Every month we try and update this database with for h. pylori cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for h. pylori cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.