Symptoms and General Pathology

All Conditions

Digestive System Diseases

Necrosis

Crohn Disease

Inflammatory Bowel Diseases

Intestinal Diseases

Colitis

Colitis, Ulcerative

Ulcer

Gastroenteritis

Gastrointestinal Diseases

Colonic Diseases

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

IBD patients who start or re-start anti-TNF therapy

Edyta Zagorowicz, MD,PhD

Jaroslaw Kierkus, MD,PhD

Edyta Zagorowicz, MD, PhD

Marek Bugajski, MD

Magdalena Chruscielewska-Kiliszek, MD, PhD

Anna Pietrzak, MD

Jaroslaw Kierkus, MD, PhD

Maria Klopocka, MD, PhD

Maria Wisniewska-Jarosinska, MD, PhD

Anti-TNF (tumor necrosis factor) monoclonal antibodies have revolutionized management of Inflammatory bowel disease. Their common features include high efficacy but also immunogenicity and increased infection risk. Since 2013, two generics or biosimilars of the first anti-TNF have been registered in Europe, which long lerm safety profile needs yet to be established.

This prospective, multicenter, observational cohort study will assess safety of treatment of anti-TNF monoclonal antibodies in inflammatory bowel disease patients in Poland.

Eligible are consecutive patients in whom anti-TNF is started for Crohn's disease, ulcerative colitis or indeterminate colitis between January 1st, 2014 and December 31st, 2015. Data to be collected include demography, Montreal classification, indication to treatment, previous treatment, operations, extraintestinal manifestations and concomitant diseases. Data on response, tolerability and safety of anti-TNF and on concomitant treatment will be collected. Adverse events logs will be completed. Majority of IBD centres in Poland, pediatric and adult, academic and regional, have agreed to participate in the study.

As a result of the study, the frequency of adverse events in a cohort of Polish IBD patients on various anti-TNFs will be established.

1. This is a prospective observational study aimed to register adverse events occuring on biological treatment in inflammatory bowel disease (IBD) patients in Poland.
2. Eligible are pediatric and adult patients in whom anti-TNF (tumor necrosis factor) treatment is started for Crohn's disease, ulcerative colitis or indeterminate colitis, financed by the National Health Care System and who gave their informed consent for participation in the study (for children the consent of a parent is required).
3. The study data are collected in a dedicated on-line data - base.
4. Each centre participating in the study is obliged to screen for the study all consecutive patients in whom the biological treatment is started. If a patient refuses to consent, this information must have been documented in the data - base.
5. Patient data collected at the start of anti-TNF treatment include the type of anti-TNF, demographic data, the type, extension or location, course and activity of IBD, indication to biological treatment, history of previous treatment, operations, extraintestinal manifestations and co-existing diseases. As regards to the anti-TNFs, biosimilars are categorised as distinct drugs in order to separately follow-up the safety profile of each.
6. Data on response, tolerability and safety of anti-TNF and on concomitant treatment are updated following each visit. Adverse events logs and serious adverse events log are completed if necessary.
7. Registration of new patients will be ongoing from Jan 2014 do Dec 2015. After this time, a centre may choose to continue doing the study.
8. In addition, data on health events in enrolled patients will be collected independently from the National Health Care System database, also after the on-site observation of patients is completed.

Safety of Anti-tumor Necrosis Factor (TNF) Monoclonal Antibodies in Inflammatory Bowel Disease

Safety of Anti-TNF Antibodies, Including Biosimilars, in Treatment of Inflammatory Bowel Disease: Multicentre Cohort Observational Study (SATIMOS)

The Children's Memorial Health Institute, Poland

Intestinal Section of the Polish Society of Gastroenterology

Maria Sklodowska-Curie National Research Institute of Oncology

MD, PhD

Behaviors and Mental Disorders

Neoplasms

Mood Disorders

Cognition Disorders

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Rectal Diseases

Patient with digestive cancer or IBD having surgery with intestinal resection planned in the Visceral Surgery Department of St Antoine Hospital

Jérémie LEFEVRE, PU-PH

Harry SOKOL, PU-PH

Franck VERDONK, MD, PhD

Constitution of a biobank of tissues, whole blood and plasma samples and stools to identify markers associated with treatment response, postoperative morbidity including neuro-cognitive and mood complications and prognosis of Inflammatory Bowel disease or colorectal cancer.

Inflammatory Bowel disease (Crohn, Ulcerative colitis) and colorectal cancer are frequent affections and the microbiota plays a major role in their physiopathology involving the immune system. In this setting, the interplay between gut microbiota and brain is still unexplored.

To evaluate the interaction of the microbiota and the immune system with the host in these two chronic diseases, we aim to create a prospective biobank.

A small amount of tissue will be taken during surgery. A whole blood, plasma and stoll samples will also be taken from the patient.

All samples will be anonymized.

* Intestinal surgical waste: Surgical samples will be rinsed in saline and aliquoted in dry tubes (minimum 5 aliquots) and lateral RNA (minimum 3 aliquots) and then frozen at -80°C
* Intestinal contents: They will be aliquoted (at least 5 aliquots) in dry tubes for freezing at -80°C
* blood samples (1 dry tube and 2 EDTA tubes of 7ml): centrifigation and aliquoting of serum and plasma, storage at -80°C
* whole blood samples (1 sodium heparin tube of 5ml) : stimulation and fixation with proteomic stabilizer, storage at -80°
* DNA ; Stored at -20°C
* stools: aliquoting and storage at -80°C

Digestive Biobank for Exploring Microbiota-host Interactions

identify relations between serumon response to treatment, postoperative outcomes including neuro-cognitive and mood complications and prognosis.

identify relations between plasma on response to treatment, postoperative outcomes including neuro-cognitive and mood complications and prognosis.

identify relations between DNA on response to treatment, postoperative outcomes including neuro-cognitive and mood complications and prognosis.

identify relations between faeces) on response to treatment, postoperative outcomes including neuro-cognitive and mood complications and prognosis.

genetic polymorphisms, serum markers, intestinal microbiota markers to determining the occurrence of intestinal and extra-intestinal complications

genetic polymorphisms, serum markers, intestinal microbiota markers determining : response to treatments

genetic polymorphisms, serum markers, intestinal microbiota markers determining : interactions between host and microbiota

Exploring the pathophysiology of host-microbiota interactions in postoperative cognitive or behavioral changes involving inflammation pathways

Study title	NCT ID	Conditions	Eligibility	Organization
Safety of Anti-tumor Necrosis Factor (TNF) Monoclonal Antibodies in Inflammatory Bowel Disease	NCT02066272	Inflammatory Bo... Ulcerative Coli... Crohn's Disease Indeterminate C...	-	Maria Sklodowska-Curie National Research Institute of Oncology
Digestive Biobank for Exploring Microbiota-host Interactions	NCT05704413	Inflammatory Bo... Crohn Disease Ulcerative Coli... Colorectal Canc... Indeterminate C...	18 Years -	Assistance Publique - Hôpitaux de Paris
Safety of Anti-tumor Necrosis Factor (TNF) Monoclonal Antibodies in Inflammatory Bowel Disease	NCT02066272	Inflammatory Bo... Ulcerative Coli... Crohn's Disease Indeterminate C...	-	Maria Sklodowska-Curie National Research Institute of Oncology
Digestive Biobank for Exploring Microbiota-host Interactions	NCT05704413	Inflammatory Bo... Crohn Disease Ulcerative Coli... Colorectal Canc... Indeterminate C...	18 Years -	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for indeterminate colitis