Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Colorectal Neoplasms

Colitis

Adenoma

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Gastroenteritis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Chronic Graft Versus Host Disease

We enroll adults older than 18 years with chronic lower GI symptoms for more than 1 month and are scheduled for a colonoscopy. The lower GI symptoms consist of any of the followings; lower abdominal pain, constipation, diarrhea, rectal bleeding, change in stool caliber, and abdominal bloating.

To calculate the diagnostic accuracy of fecal calprotectin in the diagnosis of significant ileocolonic lesions

Fecal calprotectin

To calculate the diagnostic accuracy of the fecal immunochemical test in the diagnosis of significant ileocolonic lesions

Fecal immunochemical test

Julajak Limsrivilai, MD, MS

Chronic lower gastrointestinal (GI) symptoms, including lower abdominal pain, bowel habit change, bleeding per rectum, and abdominal bloating, are caused by functional gastrointestinal disorders (FGID) and organic intestinal disorders, including colorectal cancer and chronic colitis. The presence of alarming features, such as the age of onset older than 50 years, rectal bleeding, anemia, significant weight loss, and family history of colorectal cancer, indicates organic diseases, and colonoscopy should be required. However, using only alarming features may not be sufficiently accurate. For example, anemia or significant weight loss, which are highly specific for organic disorders, usually occur in late-stage diseases. Conversely, the parameters with high sensitivity, such as the age of onset after 50 years, have a low specificity; colonoscopy in these patients may not be urgent. Therefore, tests that can help discriminate organic from functional diseases are warranted. Immunochemical fecal occult blood tests (iFOBT) and fecal calprotectin (FC) are biomarkers that indicate organic lesions in the gastrointestinal tract and could help diagnose patients with lower GI symptoms more accurately.

This study was a single-center, prospective cohort study undertaken at Siriraj hospital between March 2020 to November 2022. Eligible participants were required to collect their stool samples one to two days before the bowel preparation. The stool was sent for fresh smear examination, quantitative FIT (OC-SENSOR, EIKEN CHEMICAL, Japan), and quantitative fecal calprotectin (EliA Calprotectin 2, Phadia, Sweden). Blood samples were obtained on the day of the colonoscopy and were tested for complete blood count, albumin, and C-reactive protein (CRP) levels. In addition, clinical information was obtained, including alarm features such as the age of onset older than 50 years, rectal bleeding, anemia, significant weight loss, and family history of colorectal cancer. Colonoscopic findings and histopathological findings were used as the reference standard for diagnosis. We analyzed the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for diagnosing significant ileocolonic lesions, including colorectal cancer, advanced adenoma, and colitis, of each diagnostic modality comparing to the reference standard.

FIT and Fecal Calprotectin in Patients With Chronic Lower GI Symptoms

Diagnostic Performance of Fecal Immunochemical Test and Fecal Calprotectin in Detection of Ileocolonic Lesions in Patients With Chronic Lower Gastrointestinal Symptoms

The sensitivity, specificity, and accuracy of fecal calprotectin in diagnosis of significant ileocolonic lesions, including colorectal cancer, advanced adenoma, and ileocolitis, compared to colonoscopic diagnosis

The sensitivity, specificity, and accuracy of fecal immunochemical test in diagnosis of significant ileocolonic lesions, including colorectal cancer, advanced adenoma, and ileocolitis, compared to colonoscopic diagnosis

Mahidol University

Associate Professor

Herbal and Botanical

All Drugs and Chemicals

Cola

Chul Min Park, MD

Yeo-Min Yun, MD, PhD

The fecal calprotectin assay is used widely for inflammatory bowel disease diagnosis and the assessment of the disease activity. Some adenoma patients have elevated fecal calprotectin level, which could mean the role of fecal calprotectin as a screening marker for colon adenoma. We will investigate the usefulness of fecal calprotectin as colon adenoma marker for screening in this study.

Usefulness of Calprotectin for Colon Adenoma Screening

Usefulness of Fecal Calprotectin for Screening Colon Adenoma in Korean Population

Konkuk University Medical Center

clinical instructor

Symptoms and General Pathology

Crohn Disease

Necrosis

Inflammatory Bowel Diseases

Dermatologic Agents

Gastrointestinal Agents

Antibodies

Ustekinumab

Vedolizumab

Immunoglobulins

Patients presenting an active crohn's disease (HBI score ≥ 4) with an indication of treatment by ustekinumab because of failure or unacceptable side effects of previous treatments, and who have already been treated by at least one anti TNF The patients must be 18 years old or older.

The clinical response is defined as a decrease in the Crohn's Disease Activity Index (CDAI) score ≥ 100 points or a decrease in the HBI score ≥ 3 points.

Evaluation of biological predictive factors of clinical response to ustekinumab

Ustekinumab is a fully human Immune Globulin Gk (IgGk) monoclonal antibody against the common p40 subunit of interleukin-12 and interleukin-23, which are implicated in the pathogenesis of inflammatory bowel disease. Its efficiency to induce and maintain clinical response in patients with anti TNF resistant Crohn's disease has been proved in several clinical trials, and the profile of safety of this treatment was good, but the investigators have few data about biological characteristics of patients treated by Ustekinumab, particularly about ustekinumab through levels and rate of patients developing anti ustekinumab antibodies during the induction and maintenance stages, and no predictive factors of clinical response have been identified yet.

The aim of this study will be to assess the evolution of biological markers of inflammation and ustekinumab trough levels and antibodies, in responders and non responders patients treated by ustekinumab, in order to identify predictive factors of clinical response.

The investigators will perform a prospective observational study, including the patients followed in the University hospital center of Lyon and treated by ustekinumab for a moderate to severe Crohn's disease (with a HBI score≥4 ). All the patients included will have been previously treated by at least one anti TNF and/or Vedolizumab, with specified criteria for a primary non response, a secondary loss of response or unacceptable side effects.

Then, clinical and biological data will be collected for each patient at the inclusion, and then at weeks 4, 8, 16, 24: HBI score, sides effects, extra intestinal manifestations, steroids withdraw, CRP, calprotectin, ustekinumab trough levels and ustekinumab antibodies.

The investigators will compare responding and non responding patients at week 16 (end of the induction period) according to these data.

The hypothesis the investigators state is that an early and significant decrease of the inflammation markers in blood and stools associated with a high ustekinumab through level in blood is associated with a clinical response at week 16 in the patients treated by ustekinumab

Three blood samples of 4 ml, one stool sample of 50 mg

Predictive Factors of Clinical Response to Ustekinumab in Active Crohn's Disease

Identification of Biological Predictive Factors of Clinical Response to Ustekinumab in Patients With Anti-Tumor Necrosis Factor (TNF) Antagonists Refractory Crohn's Disease: Interest of Dosage of C Reactive Protein (CRP), Calprotectin, Ustekinumab Through Levels and Antibodies

Dosage of ustekinumab through level and ustekinumab antibodies: one 4ml blood sample

-Inflammation markers are evaluated : Dosage of CRP and leucocytes in blood: two 4ml blood sample

-Inflammation markers are evaluated : Dosage of calprotectin in stools: one about 50 mg stools sample

Clinical evaluation is realized by a medical visit with physical examination

Clinical evaluation is realized by a medical visit with evaluation of:

* the efficiency of the treatment: evaluation of well being, abdominal pain, stools numbers per day, presence or not of peri anal lesion, arthralgia, fever
* the tolerance/potential side effects of the treatment: infections, headache, skin rash, nausea, allergic reaction, or any clinical manifestation that could be imputed to the treatment

Hospices Civils de Lyon

Behaviors and Mental Disorders

Syndrome

Colitis, Ulcerative

Ulcer

Quality of Life

Anti-Inflammatory Agents

Antirheumatic Agents

Antineoplastic Agents

Adalimumab

Mercaptopurine

Immunosuppressive Agents

Azathioprine

Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine \[AZA\]/ 6-mercaptopurine \[6-MP\]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.

Alexander Dorr, MD

The objectives of this study are to explore the fecal calprotectin (fC) levels of UC patients under adalimumab therapy and the correlation with their general wellbeing (Quality of Life \[QoL\]), workability, and disease activity.

This is a non-interventional, observational study in which Humira (adalimumab) is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. The assignment of the patient to a adalimumab containing regimen has to be decided in advance and has to be current practice. The prescription of adalimumab is clearly separated from the decision to include the participant in this study.

Fecal Calprotectin Levels, Quality of Life, and Workability in Patients Suffering From Ulcerative Colitis Under Adalimumab Therapy - AdaProQuo

Fecal Calprotectin Levels, Quality of Life and Workability in Patients Suffering From Ulcerative Colitis Under Adalimumab Therapy - AdaProQuo

Fecal calprotectin (fC) is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. The study was terminated due to low enrollment. Although no meaningful analysis can be presented, data for subjects with available data for fC levels at Month 12 at the end of study (termination) are provided.

The WPAI:UC is a questionnaire used to evaluate lost productivity (work time missed and work and activity impairment) during the past 7 days due to UC. The scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-UC is calculated by deducting the final score from the baseline score. Increased (positive) scores correspond to a reduction in the percentage of lost work productivity.

The sIBDQ is a disease-specific health-related quality of life (QoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The sIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and divided by 10 for a mean score ranging from 1 (poor QoL) to 7 (good QoL). Increased scores correspond to an improvement in QoL.

A partial mayo score (mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment \[PGA\]).

Fecal calprotectin (fC) is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. A partial mayo score (mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA).

fC is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. The sIBDQ is a disease-specific health-related QoL questionnaire, able to detect and define meaningful clinical changes in IBD patients by measuring physical, social and emotional status. The sIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and divided by 10 for a mean score ranging from 1 (poor QoL) to 7 (good QoL).

Fecal calprotectin (fC) is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. The WPAI:UC is a questionnaire used to evaluate lost productivity (work time missed and work and activity impairment) during the past 7 days due to UC. The scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.

AbbVie

Moderate to Severe Ulcerative Colitis

Age, Continuous

Gender

fC is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. A total of 8 participants had fC baseline data available.

Fecal calprotectin (fC) levels at baseline

All enrolled participants with demographic and baseline data available.

The study was terminated due to low enrollment; therefore, safety and efficacy data should be interpreted with caution because of the small number of participants and incomplete data.

Global Medical Information

Enrolled participants with Month 12 data at the time of study termination

Percentage of Patients With Fecal Calprotectin (fC) Level ≤ 150 µg/g After 12 Months of Treatment With Adalimumab

The study was terminated due to low enrollment and data were not collected.

Change From Baseline to Month 12 in Patient's Workability Measured Using the Work Productivity and Activity Impairment:Ulcerative Colitis (WPAI:UC) Questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
FIT and Fecal Calprotectin in Patients With Chronic Lower GI Symptoms	NCT05514561	Colorectal Canc... Colorectal Aden... Colitis	Fecal calprotec... Fecal immunoche...	18 Years -	Mahidol University
FIT and Fecal Calprotectin in Patients With Chronic Lower GI Symptoms	NCT05514561	Colorectal Canc... Colorectal Aden... Colitis	Fecal calprotec... Fecal immunoche...	18 Years -	Mahidol University
Usefulness of Calprotectin for Colon Adenoma Screening	NCT01719198	Colon Adenoma		18 Years -	Konkuk University Medical Center
Predictive Factors of Clinical Response to Ustekinumab in Active Crohn's Disease	NCT03351647	Crohn Disease	Evaluation of b...	18 Years - 18 Years	Hospices Civils de Lyon
Fecal Calprotectin Levels, Quality of Life, and Workability in Patients Suffering From Ulcerative Colitis Under Adalimumab Therapy - AdaProQuo	NCT02092389	Moderate to Sev...		18 Years -	AbbVie
Fecal Calprotectin Levels, Quality of Life, and Workability in Patients Suffering From Ulcerative Colitis Under Adalimumab Therapy - AdaProQuo	NCT02092389	Moderate to Sev...		18 Years -	AbbVie

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