Project application form SIBDC-Project Nr: SWISSIBD cohort study Title: Short title (optional): Authors: Administrative Information Corresponding investigator: Responsible investigator: Coordinating centre: Study sites: Study starting date: Study duration: Budget information: Amount allocated by SIBDCS (nested projects only): Other grants allocated (donator’s name and amount): Date of first submission: If this is a revised protocol: Date of resubmission: ____ I confirm that I have read the Guidelines for Project Submission and that the project fulfils all criteria. (Any issue that might interfere with the guidelines should be discussed in a cover letter) _____ I confirm that all co-authors have seen the current version of the project and agreed with the submission of the current version of the protocol Document1 page 1/17 Project application form If the current version is a revision of a previously submitted proposal: Give a point-by-point reply to the comments received from the Scientific Board and highlight the resulting relevant changes in this proposal with yellow. Point-by-point reply to the comments from the Scientific Board: - Submit the project to: sibdcs-submission@chuv.ch page 2/17 Project application form Summary (structured, max 300 words) Background [Present state of knowledge in the area of the proposed research with key references] Study Hypotheses [Description of the hypothesis which this project proposes to test] Study Aims and Objectives [Major aim and objectives of the project in relation to state of knowledge. Scientific and practical significance of the proposed research] Own Research in the Field [Relevant experience and list of publications of the corresponding author. Relevant background information on the other investigators] Methodology 1.1 Patients [Precise list of inclusion and exclusion criteria of patients that should be included in the present study. Preliminary enquiry should be made to the Datacentre in order to evaluate total number of eligible patients. Give the results and details of sample size calculation] 1.2 Study design [Description of the overall study design. Description of the processes for data collection, and the rationale behind this method. Include a flow chart of the project] 1.3 Data Analysis [Description of the complete list of variables to be used to answer the question, with arguments behind the choice. List and definition of the principal and secondary outcomes. Description of the statistical methods to be employed] Time Frame [Time-frame for the project (including explicit and detailed research tasks to be performed within the credit and the duration of the project)] Submit the project to: sibdcs-submission@chuv.ch page 3/17 Project application form Status of Ethical Approval [Mention of the ethics approval or amendment this research protocol refers to. Ethical committee to contact (if applicable)] Study Budget (must be detailed) [Indicate infrastructure and manpower already available for the study. Indicate what funds you expect to obtain from other sources (industry, SNFS, foundations, etc...). The budget should include appropriate details as well as external funded expenses. For personnel, the requested position(s) and duration should be justified by a description of the tasks. The budget of the study should take into account only costs not already covered by the SIBDCS core research projects and infrastructure. Specify the following costs: personnel, laboratory tests, specimen retrieval, reimbursement to the participating centers, special tasks requested from the Datacenter, diverse.] Other Information [Interim analysis (if applicable). How you imagine disseminating your results (publication in scientific journal, thesis, internal report, conference, etc.). A proposal for authorship should be part of each submitted project. National or international collaborations (if applicable).DTA or MTA (if applicable)] References APPENDIXES: - Variables lists and definitions (enrolment & follow-up physician questionnaires) - Check list for requested biosamples Submit the project to: sibdcs-submission@chuv.ch page 4/17 Project application form Requests for Biosamples from the SIBDCS Biobank - Check list Please include the following documents / information with your request for biosamples () Title/ID of the research project: ……………………………………………………. Copy of the approved research proposal Members of the SIBDCS consortium: Copy of the acceptance letter for the project by the Head of the Scientific Committee External requests (Non-SIBDCS Members): Copy of the signed Material Transfer Agreement (MTA) Maximum number of serum samples requested: N = .................. Minimum amount (in microliter) of serum required per sample ........ Maximum number of plasma samples requested: N = .................. Minimum amount (in microliter) of plasma required per sample ........ Maximum number of DNA samples requested: N = .................. Minimum concentration of DNA required (determined by nanodrop®) .....ng/µl Minimum total amount of DNA required per sample .......... ng Maximum number of biopsies (in RNA later) requested: N = .................. (precise localisation and specifications according to information provided to the datacenter in Lausanne) Contact for scientific questions) ......................................................................... .............................................................................................................................. Shipping address .............................................................................................. Submit the project to: sibdcs-submission@chuv.ch page 5/17 Project application form SIBDC-Project Nr: VARIABLES AND DEFINITIONS – ENROLLEMENT AND FOLLOW-UP PHYSICIAN QUESTIONNAIRE Variable Definition Description (coding) Date of visit Date at which the follow-up questionnaire is started to be filled in Date in format DD.MM.YYYY Date of last report Date at which the last physician questionnaire was filled in, provided that it has been registered and received at the cohort datacenter Date in format DD.MM.YYYY Cohort Number (patient identification control) Unique number of identification of a patient included into the cohort Number in format XX.XXX.XXXX Gender Gender of the patient Categorical: - Male - Female Weight Weight of the patient at the date of follow-up visit Continuous variable (kg) Date of birth Date of birth of the patient Date in format DD.MM.YYYY Treating physician(s) Name of the physician(s) – GI or GP – who usually follows the patient for his/her IBD Text (CAPITAL letters) Cohort physician Name of the physician who is responsible for the follow-up visit and examination Text (CAPITAL letters) Study nurse / research assistant Name of the collaborator who is responsible for filling in the report, if applicable Text (CAPITAL letters) Current diagnosis Diagnosis of the patient at the date of follow-up visit Categorical: - Crohn’s disease - Ulcerative colitis - Indeterminate colitis Pregnancy Pregnancy status of women and number of weeks of pregnancy at the date of the follow-up visit, if applicable Categorical: - No - Yes Conception Conception activity of women/men in the period since last report to the cohort Categorical: - No - Yes - Unknown Current smoking status Smoking status at the date of follow-up visit Categorical: - Non-smoker - Stopped since last report to the cohort - Current smoker Page 6 Project application form Variable Current severity of disease: Crohn’s disease (CDAI) SIBDC-Project Nr: Definition Instantaneous measure of disease severity at the date of follow-up visit Description (coding) Page 7 Project application form SIBDC-Project Nr: Variable Current severity of disease: Ulcerative colitis / Indeterminate colitis (MTWAI) Definition Instantaneous measure of disease severity at the date of follow-up visit Description (coding) Clinical course Monthly evolution of the disease activity since the date of the last report to the cohort till to the date of the current follow-up visit Categorical: Active o Active without specifications o Active with specifications: severe, moderate, mild Not Active o Medically-induced o Surgically-induced Page 8 Project application form SIBDC-Project Nr: Variable Past AND current therapies Definition List of all therapies, PREVIOUS AND CURRENT, targeted for IBD care, taken by the patient since the last report to the cohort Drug administration Mode of drug administration Start date Date of therapy start Dosage Dosage of the drug therapy Drug and flare Flare management and use of the drug therapy Description (coding) Categorical: - None - Oral 5-ASA (Asacol®, Mesazine®, Pentasa®, Salofalk®, Dipentum®) - Topical 5-ASA (Asacol®, Salofalk®) - Sulfasalazine (Salazopyrin®) - Metronidazole (Flagyl®, Metrolag®, Arilin®) - Ciprofloxacin (Ciproxine®, Cip eco®, Ciprine®, Principrox®) - Other antibiotics, please specify - Cyclosporine (Sandimum®, Ciclosol®) - Tacrolimus (Prograf®) - Azathioprine (Imurek®, Azarek®) - 6-Mercaptopurine (Puri-Nethol®) - Infliximab (Remicade®) - Adalimumab (Humira®) - Certolizumab pegol (Cimzia®) - Methotrexate (Methotrexate®) - Budesonide (Budenofalk®, Entocort®) - Topical steroids (Entocort®, Enema®, Colifoam®, Budenofalk®) - Ursodeoxycholic acid (Ursofalk®, De-ursi®) - Bisphosphonates (Aredia®, Fosamax®, Actonel®, Zometa®, Bonviva®) - Cholestyramine (Quantalan®, Ipocol®) - Systemic steroids (Prednisone®, Calcort®) - Mutaflor® - VSL#3® Categorical: - Foam - Supp. - Enema. - i.v. - p.o. - s.c. Categorical: - Date in format MM.YY - Start date not found Categorical: - d (daily) - w (weekly) - 8w (every 8 weeks) for Infliximab - 2ow (every other week) for Adalimumab - 4w (every 4 weeks) for Certolizumab pegol - Shortening dose interval (yes, no) - On tapering scheduled (yes, no) - Targeted to flare management Page 9 Project application form SIBDC-Project Nr: Variable Definition Description (coding) Conception and pregnancy Drug therapy during conception (female and male) and pregnancy - Given during conception (male) or pregnancy Stop date Date of therapy stop - Date in format MM.YY - Stop date not found Drug response Response to the past drug therapy Categorical: - Prior successful - Failure - Unknown Reasons for failure Reasons for drug failure Categorical: - Breakthrough / loss of response - Primary non response (never effective) - Side effects / intolerance Reasons for drug discontinuation Categorical: - Patient wish - Conception / pregnancy - No longer needed - Other, specify Other reasons for discontinuation Page 10 Project application form Variable Therapy adverse events of stopped therapies SIBDC-Project Nr: Definition Adverse events related to drugs that were stopped since last report to the cohort Description (coding) Categorical: - None - Abd. Pain / Diarrhea - Abnormal taste - Anaphylaxia - Arthralgias - Bowel obstruction - Cataracts / Glaucoma - Cough / Pneumonitis - Cushingoid features - Diabetes / Glucose intoler. - Exanthema - Gastrointestinal intolerance, please specify - Headache - Hepatitis - Hirsutism - Hypersensitivity reaction, please specify - Injection site pain - Leucopenia/Thrombopenia/Lymphopenia - Liver cirrhosis / Fibrosis - Lupus like syndroma - Myalgias - Nausea / Abd. Pain - Nausea / Diarrhea - Neuropathy - Nephritis - Oedema - Opportunistic infections - Osteonecrosis - Osteopenia / Osteoporosis - Pancreatitis (Lipase) - Pseudomemb. Colitis - Psoriasis-like Exanthema / skin effection - Psychosis / Depression - Pyrexia - Renal hypertension - Seizure / Coma - Sinusitis / Upper resp tr inf - Stomatitis / Mucositis - TBC - Tendinitis /Tenosynovitis - Tremor - Wheeze / Cough / Dyspnea - Other adverse events, please specify Page 11 Project application form SIBDC-Project Nr: Variable Supplementation therapy Definition Supplementation therapies taken by the patient since the last report to the cohort Laboratory values Most recent core and optional laboratory values obtained for the patient within +/- 3 months Date of blood sample Date of blood sample withdrawal Time of blood sample Time of blood sample withdrawal Description (coding) Categorical: - None - Magnesium - Calcium - Folate - Oral iron - i.v. iron - Lactase - Potassium - Fish oil / Omega 3 - Multivitamins - Vitamin D - Vitamin E - Vit. B12 - Pancreatic enzyme - Enteral nutrition - Parenteral nutrition - Other, please specify - Bioflorin® (Probiotic) - Perenterol® (Probiotic) - Other probiotics, please specify Categorical: - Leucocytes - Hb - Ht - CRP - ESR (VS / BSG) - Fecal calprotection - Ferritine - Vit. B12 - Folate - Alk. Phosp. - Albumin - ALAT / SGPT - ASAT / SOPT - Date in format DD.MM.YYYY - At date of follow-up - Time in format HH.MM Page 12 Project application form Variable SIBDC-Project Nr: Definition Description (coding) Factors related to the last flare Specific risk factors for the last reported flare Categorical: - None - NSAIDs - Antibiotics, specify - GI tract infections - Other infection - Treatment decrease / discontinuation - Other medication Date of flare Start date of the LAST reported flare Management Management of the LAST reported flare - Date in format MM.YYYY - No new flare since last report to the cohort - Hospitalization (number, total days) - Ambulatory - Surgery - Drug therapy Last disease location assessment Method used to newly assess the disease location since the last report to the cohort Categorical: - no new evaluation since last report to the cohort - unknown - New evaluation: - Endoscopic studies - Surgery - Radiological studies Date of disease location assessment Date at which the examination was performed to assess the disease location Date in format MM.YYYY Endoscopic activity Endoscopic activity of unhealthy bowel segments Histological findings Histological findings made during endoscopic or surgical assessment Categorical: - Active - Inactive - Unknown - No biopsy performed - Histological findings: yes, no, unknown Page 13 Project application form Variable Intestinal resection surgeries Surgery for fistula and abscesses Other abdominal surgery SIBDC-Project Nr: Definition Type of performed resection surgeries performed since the date of the last follow-up report Type of surgeries involving fistula and abscesses performed since the date of the last follow-up report Type of other abdominal surgeries performed since the date of the last follow-up report Description (coding) Categorical: - None - Ileal resection (synonymous (syn.): resection ileo-ileal, resection term ileum) - Other small bowel resection (syn.: jejunal or jejunum resection, resection jejunum 110cm, or resection of medul diverticulum) - Ileo-caecal resection (syn.: ileo-caecal recaecectomy, ileo-ascendant anastomosis) - Right colectomy (syn.: ileo-transverse anastomosis, ileo-trans anastomosis, right hemicolectomy, right partial colectomy) - Left colectomy (syn.: left hemicolectomy) - Ileostomy (syn.: Terminal ileostomy) Closure of ileostomy - Colostomy (syn.: sigmoidostomy, transversostomy) Closure of colostomy (syn.: colorectal anastomosis) - Sigmoid resection (syn. anterior colon resection, Sigma resection, Sigma segment resection, Sigmoïd part resection, or sigmoïdectomy) - Protectomy (syn.: low anterior resection, rectum resection, total proctectomy) - Stricturoplasty - Subtotal colectomy (syn.: ileo-rectal anastomosis, ileo-sigmoid anastomosis) ileostomy ileo-rectal anastomosis - Total proctocolectomyn (syn.: total colectomy, total coloproctectomy) ileostomy ileo-anal pouch Categorical: - Fistula plug - Perianal abscess drainage - Fistulectomy/Fistulotomy - Seton drainage - Intra-abdominal abscess drainage - Fibrin glue instillation - Mucosal sliding flap Categorical: - Adhesiolysis - Appendectomy - Cholecystectomy - Other abdominal surgeries Page 14 Project application form Variable SIBDC-Project Nr: Definition Description (coding) Exams All new exams performed since the date of the last report to the cohort Categorical: - None - Colonoscopy - Gastrocopy - CT scan - MRI scan - Ultrasonography - Wireless capsule - Other new exams Clinical outcomes All outcomes originated by a new exam for each CONCERNED month since the date of the last report to the cohort Extraintestinal manifestations (EIM) Indicate all extraintestinal manifestations reported since the date of the last report to the cohort Categorical: - No outcomes - Mucosal healing - Active disease - Inactive scars - Stenosis - Abscess - Fistula - Other outcomes Categorical: - None - Peripheral arthritis/arthralgia - Uveitis/Iritis - Pyoderma gangrenosum - Erythema nodosum - Aphtous oral ulcers/ stomatitis - Ankylosing spondilitis (Bechterew) - Sacroilitis - Primary sclerosing cholangitis - Other EIM Page 15 Project application form SIBDC-Project Nr: Variable Type of complications Definition Indicate any complications reported for each CONCERNED month since the date of the last report to the cohort Description (coding) Fistulas, abscesses, fissure The location of origin of the complication (fistulas, abscesses and/or fissures), the code number of the complication Status of fistula, abscesses, and/or fissures Status and time point(s) that the complication (fistula, abscesses and/or fissure) occurred since the date of the last report Stenosis Presence and location of stenosis occurred since the date of the last report Categorical: - None - Low perianal fistula (B-E) - High perianal fistula (A) - Perineal fistula - Rectovaginal fistula - Entero-enteral fistula - Entero-vesical fistula - Entero-cutaneous fistula - Other fistula (specify) - Perianal abscess - Abdominal abscess - Other abscess (specify) - Anal fissure Categorical: - Surgical therapy - Steady state - New/Reopening - Improvement - Closure Categorical: - None - Oesophagus (A) - Duodenum/Jejunum (B) - Ileum (C) - Large bowel (D-H) - Rectum (I) - Anus (J) - Anastomosis Categorical: - None - Colorectal cancer - Colon dysplasia - Intestinal lymphoma - Osteoponia/osteoporosis - Anemia (not due to drug AE) - Deep venous thrombosis - Pulmonary embolism - Nephrolitiasis - Gallstone - Malabsorption syndrome - Massive hemorrhage - Perforation/peritonitis - Pouchitis - Other complication Page 16 Project application form SIBDC-Project Nr: Variable Definition Stenosis status Status of stenosis (complication) and time point(s) it occurred since the date of the last report Length of stenosis Length of the current stenosis Description (coding) Categorical: - Operation - Dilation - No intervention - Symptoms resolved (yes, no) Length of stenosis: - ≤ 7cm, - >7 cm - unknown Page 17