Neoplasms

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Treatment will be administered on an outpatient basis. FOLFIRI is administered by IV infusion every 2 weeks. The dose should be based on the patient's actual baseline body weight; the dose will be recalculated if there is a weight change of \> 10% from baseline.

SOM 230 will be administered as an intramuscular dose determined by the dosing schema, every 28 days.

Participants will be given one LAR dose injected into the muscle of the buttocks by a study nurse about once every 28 days until unacceptable toxicity or progression of the disease.

SOM230C LAR

FOLFIRI Infusion

Richard Kim, M.D.

This is a single-arm, open-label, phase I study of combination therapy with SOM 230 and FOLFIRI. We will utilize a sequential dose-escalation design to define the maximum tolerated dose (MTD) of SOM 230 when combined with standard doses of FOLFIRI.

The goal of this clinical research study is to learn if the study drug SOM 230, also known as Pasireotide long-acting release (LAR), in addition to standard therapy of FOLFIRI (5FU, leucovorin, and irrinotecan) can shrink or slow the growth of gastrointestinal malignancies. The safety of this drug in combination with standard chemotherapy (FOLFIRI) will also be studied. The participant's physical state, changes in the size of the tumor, and laboratory findings taken while on-study will help us decide if Pasireotide LAR is safe and effective.

Phase I Trial of Combination of FOLFIRI and SOM 230

Phase I Trial of Combination of FOLFIRI and SOM 230 in Advanced Gastrointestinal Malignancies

To determine the maximum tolerated dose (using a standard 3+3 design), of SOM 230 and FOLFIRI.

Evaluate the frequency of toxicities by type and severity, and dose of study drug according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.

Evaluate the frequency of tumor response by dose cohort according to the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.

Novartis

H. Lee Moffitt Cancer Center and Research Institute

Symptoms and General Pathology

Rare Diseases

Recurrence

Gastrointestinal Stromal Tumors

Disease Attributes

Imatinib Mesylate

The series comprises 77 patients, of which 29 (37.7%) were located in the jejunum or ileum (JI-GIST).

The series comprises 77 patients, of which 48 (62.3%) were located in the stomach (G-GIST).

Introduction: Gastrointestinal Stromal Tumors (GISTs) located in the jejunum or ileum (JI-GIST) are considered of worse prognosis compared to other locations. It has been suggested that this dogma should be revised. The aim of this study is to describe the characteristics of jejunoileal GISTs and its prognosis; and to compare them with gastric GISTs in the era of imatinib.

Patients and methods: We retrospectively reviewed the clinical histories of all the patients diagnosed with GISTs between January 2000 and November 2016. Clinical and pathological data, as well recurrence, metastatic, disease-free survival (DFS) as overall (OS) rates of patients with JI-GIST or gastric GIST (G-GIST) were collected and compared.

Jejunoileal vs Gastric GIST in the Era of Imatinib.

Characteristics and Prognosis of Jejunoileal Gastrointestinal Stromal Tumors (GISTs) in the Era of Imatinib. A Comparative Retrospective Study With Gastric GISTs.

Number of patients with a molecular analysis positive for KIT mutation

Number of patients with a molecular analysis positive for PDGFRA mutation

Number of patients with immunohistochemical expression of CD117

Number of patients with immunohistochemical expression of DOG1

Number of patients with recurrence after treatment with tyrosinkin inhibitors.

Number of patients deceased during follow-up.

Location of the tumor (gastric o jejunoileal)

Hospital Universitario Virgen de la Arrixaca

Principal Investigator

Nutritional and Metabolic Diseases

Crohn Disease

Diarrhea

Intestinal Diseases

Celiac Disease

Inflammatory Bowel Diseases

Gastroenteritis

Signs and Symptoms, Digestive

Syndrome

Malabsorption Syndromes

Metabolic Diseases

Chronic Graft Versus Host Disease

Xavier DRAY, MD PhD

Romain LEENHARDT, MD

Patients participating to this study will provide images and videos of capsule endoscopy to train, tune and evaluate technological bricks of artificial intelligence solutions, in order to improve diagnostic performances of the procedure, while reducing reading time by physicians.

Capsule endoscopy is a minimally-invasive diagnostic procedure based on the ingestion (or endoscopic delivery) of a miniaturized biocompatible, camera. Capsules capture tenths of thousands images of the digestive tract. Reading the captured images and reporting is long, tedious, and at risk of errors when the reader's attention is disturbed. Artificial intelligence is expected to alleviate these limitations, by both improving diagnostic performances of capsule endoscopy while reducing reading time.

Any patient in whom a capsule endoscopy examination is performed as part of routine care will be invited to participate to the study. Their de-identified images and videos will be extracted, thus allowing the creation of several databases for training, tuning and testing technological bricks of artificial intelligence. Basic clinical data will be collected (age, gender, indication for capsule endoscopy, type of device, ingestion or delivery of capsule). Images and videos will be characterized centrally and consensually by a panel of 3 expert readers, according to their level of relevance in relation to the type and indication of capsule endoscopy.

The various, developed technological bricks will aim to automatically detect and characterize anatomical landmarks and abnormal findings, and to quote the intestine cleanliness.

Assessment of diagnostic performance and reading time will be performed within a few months or up to five years, for each technological brick, individually and then combined, according to their stepwise development.

Development of New Diagnostic Tools in Capsule Endoscopy

Sensitivity in detection of lesions of intermediate to high relevance as identified centrally and consensually by a panel of 3 expert readers (AI vs standard reading)

Other diagnostic performance (specificity, positive and negative predictive values, accuracy) in detection of lesions of intermediate to high relevance as identified centrally and consensually by a panel of 3 expert readers (AI vs standard reading)

Time needed for detection of lesions of intermediate to high relevance as identified centrally and consensually by a panel of 3 expert readers (AI vs standard reading)

Diagnostic performances in positioning anatomical landmarks (1st gastric, small bowl and colonic images) as identified centrally and consensually by a panel of 3 expert readers (AI vs standard reading)

Diagnostic performances in quoting small bowel and colonic quality of preparation, as compared toed centrally and consensually quoted by a panel of 3 expert readers

Assistance Publique - Hôpitaux de Paris

Ulcer

Small Intestine Cancer

A wireless capsule is ingested by the patient. It moves passively along with the peristaltic movements to capture images of the small intestine. The images are processed and recorded by data recorder worn on a belt. The recorded images are downloaded and analyzed by the computer software.

Small Bowel Capsule Endosocopy

Neeraj Singla, MBBS, MD, DM

Examination of the small bowel has been considered a challenge for several anatomical (i.e. distance from external orifices, length) and physiological (i.e. active peristalsis) reasons. Conventional techniques of endoscopy are limited by length while radiologic examinations, such as barium studies, are insensitive for evaluating small bowel pathology. An ingestible miniature camera device capable of obtaining images of the whole small intestine was developed due to a need for the exploration of this "final frontier". The purpose of this article is to review and share our institution's results using small bowel capsule endoscopy, with special reference to the existing literature.

1. INTRODUCTION

   Examination of the small bowel (SB) has been considered a challenge for several anatomical (i.e. distance from external orifices, length) and physiological (i.e. active peristalsis) reasons. Conventional techniques of endoscopy are limited by length while radiologic examinations, such as barium studies, are insensitive for the evaluation of pathology in the SB. An ingestible miniature camera device capable of obtaining images of the whole small intestine was developed due to a need for the exploration of this "final frontier". Video capsule endoscopy (CE) is a breakthrough in medical history for noninvasive imaging of the entire small intestine. It was first introduced in 2000, and since then more than 700 studies have been published, which is indicative of its ease and the widespread acceptance of this new diagnostic tool. A wide range of uses for CE has been reported in the literature, but the majority of the studies have aimed to evaluate the cause of obscure gastrointestinal bleeding (OGIB).
2. RATIONALE The purpose of this article is to review and share our institution's experience using small bowel CE, with special reference to the existing literature. Most published reports on capsule endoscopy are limited to small group of patients.
3. STUDY OBJECTIVES 3A. Primary Objective- To study the indications and diagnostic yield of capsule endoscopy.

3B. Secondary Objective- To study the gastric emptying time, small bowel transit time and findings visualized with capsule endoscopy.

4. STUDY POPULATION This observational retrospective study will be conducted in AIG Hospitals, Hyderabad. All patients who underwent capsule endoscopy till 30 June, 2021 will be enrolled in the study.

5. DESIGN AND DURATION OF THE STUDY- It will be a retrospective observational study.

6. METHODOLOGY

6a. SUBJECT RECRUITMENT - All patients who underwent capsule endoscopy in our hospital till 30 June, 2021 will be enrolled in the study.

6b. RANDOMIZATION AND BLINDING- N/A

6c. STUDY METHODS- This observational study will be conducted after obtaining ethical clearance from institutional human ethical committee. All patients who underwent capsule endoscopy till date will be enrolled in the study.

6d. STUDY PROCEDURE- The data will be entered in Microsoft excel sheet and analysed ' 6e. METHODS OF ASSESSMENT- The following variables will be noted. A. Age of the patient B. Indications of the procedure C. Pre-Existing illness D. Gastric Emptying time E. Small Bowel transit time F. Capsule Retention G. Findings visualized on capsule endoscopy study

6e. STOPPING OR DISCONTINUATION CRITERIA- N/A

7. SAMPLE SIZE CALCULATION- The sample size will include all patients who underwent capsule endosocopy till 30th June 2021 in AIG hospitals Hyderabad.

8. STATISTICAL ANALYSIS- Data will be expressed as median and percentile values (5th, 25th, 75th and 95th percentiles). The upper limit of normal will be defined as the 95th percentile of expected values. P≤0.05 will be considered statistically significant.

9. ETHICAL JUSTIFICATION OF THE STUDY Small Bowel Capsule endoscopy is a safe and effective procedure for diagnosis of small bowel disorders. It is especially helpful in finding the cause for obscure gastro-intestinal bleed. There is lack of large studies on diagnostic yield and other visualized findings. This study aims to share our institution's results using small bowel CE, with special reference to the existing literature.

Small Bowel Capsule Endoscopy: Experience From a Single Large Tertiary Care Centre

The study will help find the various indications for doing capsule endoscopy for small bowel diseases.

The study will help in knowing the various findings visualized on capsule endoscopy.

he study will help find the diagnostic yield of capsule endoscopy for various small bowel diseases.

Asian Institute of Gastroenterology, India

Diseases and Abnormalities at or Before Birth

Adenocarcinoma

Lynch Syndrome II

Colorectal Neoplasms

Colorectal Neoplasms, Hereditary Nonpolyposis

Intestinal Neoplasms

Neoplastic Syndromes, Hereditary

Colonic Diseases

Genetic Diseases, Inborn

DNA Repair-Deficiency Disorders

Small Intestinal Adenocarcinoma

Video capsule endoscopy

Giulia Martina Cavestro, MD PhD

Marta Puzzono, MD

Background Lynch syndrome is caused by a pathogenic variant in one of the four Mismatch Repair genes (MMR): MLH1, MSH2/Epcam, MSH6, or PMS2. These pathogenic variants confer a higher risk of developing colorectal and other cancers, including small bowel cancer. The risk of developing a small bowel adenocarcinoma is about 100 times higher compared to individuals without Lynch syndrome, and the lifetime risk of small bowel cancer is estimated at 4,2%.

The diagnosis of a small bowel cancer depends on videocapsule endoscopy (VCE). This device is swalled so that it can record images of the small bowel, which are then stored on a wearable device for about 8 hours. The capsule is then expelled in the feces while the images are transferred to a computer to be analysed. To date, there is conflicting evidence on the efficacy of small bowel cancer screening with VCE

Rationale: this registry study will collect prospective data from patients with LS undergoing VCE

Aim: evaluate the incidence of neoplastic and pre-neoplastic lesions in patients with LS during a VCE-based small bowel cancer screening study

Design: this is a multicentric, observational study that analyzes data from diagnostic techniques already approved. Patients will not undergo diagnostic procedures beyond what would be recommended by clinical practice.

Background Lynch syndrome (LS) is caused by a pathogenic germline defect in one of the mismatch repair genes (MMR), namely MLH1, MSH2/Epcam, MSH6, or PMS2. Such pathogenic defects confer a higher risk of developing not only colorectal cancer but also small bowel cancer (SBC). Patients with LS have a lifetime risk of SMB of 4.2%, with a relative risk of \>100, compared to the general population. Moreover, patients with LS may develop SBC at a younger age, compared to SBC in individuals without LS.

The diagnostic standard for SBC is video capsule endoscopy (VCE). This consists in swallowing a pill with a camera inside. The VCE will record the images through the gastrointestinal tract and send them via Bluetooth to a wearable device for roughly 8 hours The capsule is then expelled with feces while the images are stored in a computer for later revision. Today, the data on the efficacy of a screening program for SBC in patients with LS is controversial.

Rationale This register study will collect prospective data on the VCEs done on patients with LS

Objective To estimate the incidence of neoplasia and preneoplastic lesions of the small bowel in patients with LS via VCE

Design Multicentric observational study with the use of approved diagnostic devices. It will not modify the current standard of care. The study design will not mandate obligatory studies of further procedures besides those that are clinically approved.

Population At least 10 subjects/year by each center (400 patients by study completion)

Controindications to VCE

* Stenosis, obstructions, fistulas (suspected or known)
* Cardiac defibrillators or cardiac pace-makers.
* Dysphagia
* Inability to provide written informed consent.
* Pregnancy (suspected or known).

Risks of VCE VCE retention is the most dreaded adverse events. The risk may vary between 1.5 and 21%.

Allergic reactions may be possible due to the use of sticky electrodes on the skin.

Study duration 10 years from January 2016.

Confounders To date, not known.

Data management All results will remain confidential. Clinical data may become available at scientific meetings or in published articles, but patient anonymity will always be maintained

Statistics The incidence of neoplastic and preneoplastic lesions of the subjects included in the study will be estimated. The sample size was established on the basis of feasibility (10 subjects enrolled each year for each center in 10 years = 400 patients in total). The expected incidence of small bowel injury is approximately 5%. With 400 subjects it is possible to estimate the incidence with an accuracy of 2% estimated with a 95% confidence interval.

Descriptive statistical variables (mean, standard deviation, median, etc.) will be evaluated on the collected data.

Any relationships between these variables will be evaluated using inferential statistics (t-test, chi-squared, logistic regression analysis, multivariate analysis, etc.). Any relationship with a p-value less than 0.05 will be considered significant.

Ethics The investigators declare that the study will be conducted in accordance with the ethical principles deriving from the Declaration of Helsinki and the current legislation on Observational Studies.

Informed consent. All subjects will be informed of the purpose of the study, of the confidentiality of the personal data, and of the fact that this data may be subject to review, for study-related reasons, by authorized person other than the physician.

It will be emphasized that participation is entirely voluntary and that the patient can refuse further participation in the protocol at any time without affecting the patient's subsequent care. Informed consent will be obtained for all subjects included in the study prior to their inclusion in the present study, in accordance with national and local regulations.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase I Trial of Combination of FOLFIRI and SOM 230	NCT01434069	Gastrointestina...	SOM230C LAR FOLFIRI Infusio...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Jejunoileal vs Gastric GIST in the Era of Imatinib.	NCT03923400	Disease-free Su... Overall Surviva... Recurrence		18 Years -	Hospital Universitario Virgen de la Arrixaca
Development of New Diagnostic Tools in Capsule Endoscopy	NCT06152289	Bowel Disease Crohn Disease Celiac Disease Chronic Diarrhe... Tumor		-	Assistance Publique - Hôpitaux de Paris
Development of New Diagnostic Tools in Capsule Endoscopy	NCT06152289	Bowel Disease Crohn Disease Celiac Disease Chronic Diarrhe... Tumor		-	Assistance Publique - Hôpitaux de Paris
Small Bowel Capsule Endoscopy: Experience From a Single Large Tertiary Care Centre	NCT05228379	Small Bowel Dis... Small Bowel Ulc... Capsule Endosco... Small Bowel Tum...	Small Bowel Cap...	6 Years - 87 Years	Asian Institute of Gastroenterology, India
Videocapsule Endoscopy in Lynch Syndrome	NCT05704010	Lynch Syndrome Lynch Syndrome ... Lynch Syndrome ... MLH1 Gene Mutat... MSH2 Gene Mutat... MSH6 Gene Mutat... PMS2 Gene Mutat... Small Bowel Ade...	Video capsule e...	18 Years -	San Raffaele University

Spots Global Cancer Trial Database for small bowel

Every month we try and update this database with for small bowel 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 small bowel

Every month we try and update this database with for small bowel 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 small bowel 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.