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

Symptoms and General Pathology

Inflammation

Inflammatory Bowel Diseases

screening every 3rd month: (home monitoring: FC and DA)

screening On demand: (home monitoring: FC and DA)

Home monitoring is a supportive treatment. Patients are randomized to screen themselves on demand

At Home Screening procedure On demand

Home monitoring is a supportive treatment. Patients are randomized to screen themselves every 3 months

At Home Screening procedure every 3 months

Pia Munkholm, Professor

This study is a side protocol/extension of 10 years of ClinicalTrials.gov ID: NCT02492555. The purpose of this study is to determine if the IBD patients doing home monitoring (screening themselves on demand (OD) or every 3 months) have relative reduced rates of colectomies, resections, mortalities and cancer after 11 years of web monitoring. The IBD patients are self-monitoring by web apps consisting of a short disease activity questionnaire (DA) and fecal calprotectin (FC) on any smart phone.

This study is a side protocol/extension of 10 years of ClinicalTrials.gov ID: NCT02492555. Among 2.500 IBD patients the investigators have consecutively from the Gastroenterology out-patient clinic at North Zealand University Hospital recruited in total 120 in the study.

At the out-patient consultation IBD patients has been informed about the project and the IBD eHealth nurse has ensured that no exclusion criteria was met by the patients.

Inclusion criteria:

IBD patients in remission, SCCAI ≤ 2 (Simple Clinical Colitis Activity Index )) or HBI \< 5 (Harvey \& Bradshaw Activity Index ) or in mild to moderate disease activity ( SCCAI 3-4, HBI \< 16) IBD patients who can read, speak and understand Danish. IBD patients that can take advantage of the Internet and wireless network. 18 years or older.

Exclusion criteria:

IBD patients with severe disease activity HB \> 16 SCCAI ≥ 5 IBD patients with social, medical or psychological issues of a more complex character. IBD patients with particularly complex issues such as drug and alcohol problems, severe mental / psychiatric disorders and / or serious social impact.IBD patients who cannot attend due language barrier or cognitive disorder. Age less than 18.

When the patient has agreed to participate in the study, randomized to either OD or 3. Months (This has been done ClinicalTrials.gov ID: NCT02492555)

Patients log in to www.noh.constant-care.dk at least once every 3rd months throughout the project period of 11 years in total (2015-2026). When the patient log in to the telemedicine platform the following scorings must be filled out:

1. - Disease activity (DA), respectively SCCAI or HBI.
2. - Quality of life assessment, s-IBDQ
3. - FACIT (Fatigue score)
4. - MARS ( Medical Adherence Rating Scale)
5. - FC, fecal calprotectin mg / kg measured by the patient's own SMART phone, rapid home test.

If the patients prefer to send the fecal samples for test, it will be analyzed in the ehealth gastro lab. at the hospital with a SMART phone as well.

The results of the scoring systems will appear to the health care professionals and patients in a traffic light manner (red, yellow and green).

If the patient experiences a recurrence of the disease, it moves from green to either yellow or red area in the traffic graph, and patient will further be instructed to contact Gastro medical clinic project nurse for an early consultation and decision on further treatment initiative. This will also be indicated at the patient's website. If alarm symptoms occurs patients are instructed to contact the project nurse. Thus patients are treated in accordance to national and international guideline. By screening of the inflammation burden (web algorithm), the decision is moving forward.

Patients logging in on demand, indicate disease activity, quality of life and FC at the start, and subsequently when needed and at the end of the study (after 11 years from inclusion).

At relapse, disease activity score and FC is settled and repeated no later than 7 days here after. When the patient has reached remission (green) a new DA and FC test should be performed to verify the remission.

The purpose of this study is to determine if the IBD patients doing home monitoring have relative reduced rates of colectomies, resections, mortalities and cancer after 11 years of web monitoring. Relative reduced rates of colectomies etc. means - relative to standard care but also if there is a difference between the two web screening procedures on these endpoints.

120 IBD patients has been randomized to screen for disease activity and FC either OD or every 3 months. 60 patients in each group

Are Rates of Colectomies, Resections, Mortalities and Cancer Reduced by Home Monitoring of IBD Patients ?

Are Rates of Colectomies, Resections, Mortalities and Cancer Reduced by Home Monitoring of IBD Patients Tightly on Demand or Every 3 Months by Fecal Calprotectin and Disease Activity?

Both AUC total, but also as a red \>600 mg/kg, yellow (200-600 mg/kg) and green (below 200mg/kg ) AUC will be performed from the individualized curves

Both AUC total, but also as a red \>5, yellow (2-4) and green (\< 2 ) AUC will be performed from the individualized curves

Both AUC total, but also as a red \>16 , yellow (6-16) and green (≤5) AUC will be performed from the individualized curves

Based on epidemiology four figures have been developed to describe disease-course of IBD. These figures have been used in a retrospective study (Maagaard et al. 2016) to measure change in Disease course.The four figures depicting different types of disease courses is described as follows:

1. Mild IBD with indolent course
2. Mild IBD with aggressive course
3. Chronic IBD with continuous course
4. Chronic IBD with intermittent course The patients have to choose one figure representing their disease course type the best at inclusion and 11 years later

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
Are Rates of Colectomies, Resections, Mortalities and Cancer Reduced by Home Monitoring of IBD Patients ?	NCT03038984	Inflammatory Bo...	At Home Screeni... At Home Screeni...	18 Years -	Nordsjaellands Hospital

Spots Global Cancer Trial Database for fecal calprotectin