Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Biennial, without diet restriction, 1 stool sample. Positive cut-off level: 75 ng/ml.

Immunochemical fecal occult blood test

Colonoscopy

Antoni Castells, MD

Enrique Quintero, MD

Aims:

1. To compare the efficacy of biennial immunochemical fecal occult blood test (iFOBT) versus colonoscopy every 10 years for the reduction of colorectal cancer-related mortality at 10 years in average-risk population.
2. To determine the compliance and complications associated with both strategies.

Methods: Multicenter, randomized, controlled study in 8 Spanish regions (Aragón, Canarias, Catalunya, Euskadi, Galicia, Madrid, Murcia and Valencia).

Study groups:

* Group I: iFOBT (OC Sensor®) in one stool sample, followed by colonoscopy when a positive result.
* Group II: colonoscopy.

Sample-size calculation: 27,749 subjects in each study group (total: 55,498).

Colorectal Cancer Screening in Average-risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy

Colorectal Cancer Screening in Average-risk Population: a Multicenter, Randomized Control Trial Comparing Immunochemical Fecal Occult Blood Testing Versus Colonoscopy.

Grupo Cooperativo para el Cribado del Cancer Colorrectal en España.

Gastrointestinal Oncology Group of the Spanish Gastroenterological Association

Fundacion Cientifica de la Asociacion Española contra el Cancer

Instituto de Salud Carlos III

Hospital Clinic of Barcelona

Co-principal investigator

Patients randomized to this arm will receive language-concordant patient navigation from a trained navigator, over the phone and via text and email, to assist patients to complete colonoscopy to screen for colorectal cancer.

Participants randomized to this arm will receive an educational brochure about the importance of colonoscopy to screen for colorectal cancer.

Patients will receive navigation from a trained lay navigator at a community-based nonprofit organization that supports access to high quality healthcare. The patient navigator will work with patients to schedule their colonoscopy and identify, explore, and overcome barriers. They will educate patients about the colonoscopy procedure and preparation, provide resources, and coach and motivate patients.

Patient Navigation

Usual Care Control

Allison M Cole, MD, MPH

This study aims to test the effectiveness of a patient navigation program for increasing colonoscopy completion for colorectal cancer screening, among rural populations. The study will partner with geographically disparate primary care organizations to recruit patients aged 45-75 to the study. The patient navigation program will be delivered through a community organization. This project is critical in advancing our knowledge of the effectiveness of patient navigation for increasing colonoscopy in this patient population as well as for understanding factors that can support long term implementation and sustainability of effective interventions.

Colorectal cancer (CRC) is a leading cause of cancer death in the United States and its burden is greater in rural and low-income communities. Failure to complete recommended colonoscopy contributes to later-stage CRC diagnosis and worse CRC outcomes, which means timely and successful colonoscopy is a key opportunity to reduce CRC mortality. Using a Type 1 Hybrid Implementation-Effectiveness design, we will randomize 480-600 subjects from 6-8 primary care clinical organizations in a randomized controlled trial (RCT) to accomplish the following:

* Test the effectiveness of a patient navigation program delivered by a community-based organization, for increasing colonoscopy completion rates for colorectal cancer screening among rural patients.
* Assess implementation and sustainability of the patient navigation program from the perspectives of both community and clinical stakeholders.

Colonoscopy Outreach for Rural Communities Aim 2

National Cancer Institute (NCI)

University of Washington

Associate Professor, School of Medicine

Blood and Lymph Conditions

Nutritional and Metabolic Diseases

Anemia, Iron-Deficiency

Iron Deficiencies

Anemia

Hematologic Diseases

Metabolic Diseases

Iron Metabolism Disorders

Anemia, Hypochromic

Micronutrients

All Drugs and Chemicals

Iron

In case of a positive immunochemical fecal occult blood test result, colonoscopy will be the first examination

In case of a negative immunochemical fecal occult blood test result, upper endoscopy will be the first examination

Participants will be provided with a single immunochemical fecal occult blood test. Participants will introduce a small sample of feces inside and bring the test to the hospital

A colonoscopy (procedure performed using a scope design to examine the large bowel) will be offered to the participants

An upper endoscopy (procedure performed using a scope to examine the upper digestive tract) will be offered to the participants

Upper endoscopy

Marta Carrillo, MD, PhD

ENRIQUE QUINTERO, MD. PhD.

Antonio Z Gimeno García, MD PhD

Zaida Adrián de Ganzo, MD PhD

David N Pérez, MD PhD

Marta Carrillo Palau, MD PhD

Enrique Quintero, MD, PhD

Prospective study to test whether the immunochemical fecal occult blood test (FIT) for colorectal cancer (CRC) helps to prioritize patients with iron deficiency anemia for colonoscopy.

This is a multicenter (two centers), prospective study to test the accuracy of FIT for CRC detection in patients with severe IDA and its potential value for prioritizing colonoscopy.

An appointment with a gastroenterologist will be scheduled for patients with IDA referred for upper gastrointestinal endoscopy or colonoscopy. The gastroenterologist will check the inclusion and exclusion criteria. Eligible patients will sign the informed consent to carry out the following procedures:

1. Blood analysis to rule out celiac disease (anti-transglutaminase IgA antibodies and IgA).
2. A quantitative fecal immunological test (FIT: OC-Sensor ®) will be provided.
3. An appointment for colonoscopy and gastroscopy will be provided after completion of the FIT in all patients. During gastroscopy, duodenal biopsies from the second portion of the duodenum and duodenal bulb will be taken to rule out celiac disease. Biopsies from the stomach will be also taken to assess helicobacter pylori infection.
4. In patients with severe anemia colonoscopy and upper endoscopy will be prioritized (\<20 days) (primary outcome).
5. Patients with colonoscopy and gastroscopy without significant lesions, will be scheduled for the performance of a capsule endoscopy.
6. Endoscopists will be blind for the FIT results.
7. the following information will be collected: consumption of acetylsalicylic acid, non steroidal anti inflammatory drugs, oral anticoagulants, corticosteroids and proton pump inhibitors (PPI). In the case of patients receiving treatment with PPIs, they will be removed 15 days before the completion of the FIT and not resumed until the performance of the upper endoscopy.

The hypothesis of the study is that one-time FIT is a useful tool for increasing the efficiency of colonoscopy and can be used to prioritize outpatient colonoscopy in patients with IDA. In order to calculate the sample size required for the study, the investigators have assumed that FIT is positive in 25% of cases with iron deficiency anemia and 20% of them would have an advanced colorectal neoplasia at colonoscopy whereas only 10% of advanced colorectal neoplasias would be found in the remaining 75% patients with a negative FIT. Considering a type I error (alpha) of 5%, a power of 80% and a percentage of losses of 15%, 550 patients will be necessary to include. The investigators estimate that approximately 15% of these patients (n=83) will have severe anemia.

Usefulness of Fecal Immunochemical Test in Iron Deficiency Anemia (IDAFIT)

Usefulness of Fecal Immunochemical Test in the Diagnosis Algorithm of Iron Deficiency Anemia.

In order to calculate the positive predictive value, the number of patients with events (colorectal cancers) will be divided among the number of positive immunochemical fecal tests

In order to calculate the positive predictive value, the number of patients with a significant lesion (i.e. colorectal cancer, advanced adenoma, inflammatory bowel disease, angiodysplasia, gastric cancer, watermelon stomach, gastric/duodenal ulcer, ampulloma, erosive gastritis/duodenitis) will be divided among the number of positive immunochemical fecal tests.

In order to calculate the negative predictive value, the number of patients without a significant lesion will be divided among patients with a negative immunochemical fecal test

Hospital Universitario de Canarias

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Chrysarobin

Annual FIT and colonoscopy in case of a positive test. Fecal occult blood testing: annual FIT (two rounds) without diet restriction, one stool sample. Positive cut-off = 10 μg Hemoglobin/g feces.

Colonoscopy will be performed in case of a positive FIT.

FIT and colonoscopy in case of a positive test. Annual interval (2 rounds), without diet restriction, 1 stool sample. Positive cut-off 10 mcg Hemoglobin/g feces.

annual FIT and colonoscopy in case of a positive test

colonoscopy with sedation

This is a multicenter, controlled, randomized phase III study to compare participation rate with two screening rounds of fecal occult blood test (FIT) versus one-time screening colonoscopy in first degree relatives (FDR) of patients diagnosed of colorectal cancer (CRC).

The hypothesis of the study is that annual FIT uptake and colonoscopy when a positive test is higher than that of straightforward colonoscopy. Assuming an uptake of 0.50 for colonoscopy and 0.60 for FIT, a Type I error (alpha) of 5% and a power of 90%, 538 FDRs will be necessary to include in each group.

This is a multicenter, controlled, randomized phase III study to compare participation rate with two screening rounds of FIT versus one-time screening colonoscopy in FDR of patients diagnosed of CRC.

The recruitment process will be programmed through the index case, that will be interviewed to obtain their CRC family history. FDR will be contacted in order to make an appointment in the High-risk CRC Clinic of the participant centers. Randomization will be performed before signing the informed consent to avoid selection bias. A researcher will be responsible to provide detailed information about the study and getting the informed consent. In case of willingness to participate in the study, the FDR will be randomized to one of the following arms: A) One-time colonoscopy; B) annual FIT for two screening rounds and a colonoscopy in case of a positive FIT (cut-off = 10 μg Hemoglobin/g feces). Screening uptake will be defined as the percentage of FDR who participate at least in one of the two FIT screening round in the FIT group or who undergo colonoscopy in the other group. Screening uptake will be calculated under the assumption of intention to screen analysis.

The hypothesis of the study is that annual FIT uptake and colonoscopy when a positive test is higher than that of straightforward colonoscopy. Assuming an uptake of 0.50 for colonoscopy and 0.60 for FIT, a Type I error (alpha) of 5% and a power of 90%, 538 FDRs will be necessary to include in each group.

Participants were randomized to either colonoscopy or faecal occult blood test

Uptake to Colorectal Cancer Screening in Familial-risk Population

Uptake to Colorectal Cancer Screening in Familiar-risk Population: A Randomized Controlled Trial Comparing Immunochemical Fecal Occult Blood Test With Colonoscopy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Colorectal Cancer Screening in Average-risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy	NCT00906997	Colorectal Canc... Colorectal Neop...	Immunochemical ... Colonoscopy	50 Years - 69 Years	Hospital Clinic of Barcelona
Colonoscopy Outreach for Rural Communities Aim 2	NCT05453630	Colorectal Canc...	Patient Navigat... Usual Care Cont...	45 Years - 915 Months	University of Washington
Usefulness of Fecal Immunochemical Test in Iron Deficiency Anemia (IDAFIT)	NCT02792023	Colorectal Canc...	Immunochemical ... Colonoscopy Upper endoscopy	18 Years -	Hospital Universitario de Canarias
Colonoscopy Outreach for Rural Communities Aim 2	NCT05453630	Colorectal Canc...	Patient Navigat... Usual Care Cont...	45 Years - 915 Months	University of Washington
Uptake to Colorectal Cancer Screening in Familial-risk Population	NCT02567045	Colorectal Canc... Screening Uptak...	annual FIT and ... colonoscopy wit...	18 Years - 40 Years	Hospital Universitario de Canarias

Spots Global Cancer Trial Database for immunochemical fecal occult blood test