Completed
ACRIN6664

The National CT Colonography Trial

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What is being tested

CT Colonography

Procedure
Who is being recruted

Colorectal Cancer

Over 50 Years

See all eligibility criteria

How is the trial designed

Screening Study

Interventional
Study Start: February 2005

See protocol details

Summary

Principal SponsorAmerican College of Radiology Imaging Network
Last updated: December 22, 2020
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2005Actual date on which the first participant was enrolled.

RATIONALE: New diagnostic procedures such as computed tomographic colonography may improve the ability to detect colorectal cancer and may provide a less invasive method of detection. PURPOSE: This clinical trial is studying how well computed tomographic colonography works in screening healthy participants for colorectal cancer. OBJECTIVES: Primary * Compare the sensitivity of computed tomographic colonography (CTC) vs colonoscopy for detecting significantly large lesions (≥ 10 mm in diameter) in asymptomatic participants, in terms of specificity, area under the ROC curve, and predictive values for detecting clinically significant colorectal neoplasia. Secondary * Determine the interobserver variation in accuracy of interpreting CTC examinations of these participants, including any benefits of a primary 3-dimensional read and/or independent second interpretations. * Determine the effects of different colon preparations on the accuracy of CTC in these participants. * Compare participant acceptance and willingness to have a repeat examination by CTC vs colonoscopy. * Determine the accuracy of CTC in detecting flat lesions in the colon of these participants. OUTLINE: This is a multicenter study. Participants receive an oral laxative, oral bisacodyl, and three doses of oral barium sulphate 24 hours before imaging. After cathartic cleansing, participants undergo computed tomographic colonography followed by colonoscopy. Participants are followed up for approximately 4 weeks. PROJECTED ACCRUAL: A total of 2,607 participants will be accrued for this study.

Official TitleThe National CT Colonography Trial: Multicenter Assessment of Accuracy for Detection of Large Adenomas and Cancers in a Healthy Screening Population 
Principal SponsorAmerican College of Radiology Imaging Network
Last updated: December 22, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
2600 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Screening Study
Screening studies test new methods to find diseases or risk factors early—before any symptoms appear. This helps catch health issues sooner, when they may be easier to treat.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 50 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Colorectal Cancer
Criteria

1. Inclusion Criteria * Male or female outpatients * Aged 50 years or older * Scheduled for screening colonoscopy * Participant's signed informed consent 2. Exclusion Criteria * Symptoms of disease of the lower gastrointestinal tract, including * Melanotic stools or/and hematochezia on more than one occasion in the previous six months * Lower abdominal pain that would normally require a medical evaluation * Inflammatory bowel disease and/or familial polyposis syndrome * Serious medical conditions that would increase the risk associated with colonoscopy or are so severe that screening would have no benefit * Pregnancy * Previous colonoscopy within the past five years * Anemia (hemoglobin less than 10 gm/dl) * Positive fecal occult blood test (FOBT)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
CT colonography conducted during the same assessment as colonoscopy.
Study Objectives
Primary Objectives

Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas \>=10mm (as measured at pathology) RS-: No Advanced adenomas \>=10mm found by colonoscopy (as measured at pathology)

Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas \>=9mm (as measured at pathology) RS-: No Advanced adenomas \>=9mm found by colonoscopy (as measured at pathology)

Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas \>=8mm (as measured at pathology) RS-: No Advanced adenomas \>=8mm found by colonoscopy (as measured at pathology)

Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas \>=7mm (as measured at pathology) RS-: No Advanced adenomas \>=7mm found by colonoscopy (as measured at pathology)

Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas \>=6mm (as measured at pathology) RS-: No Advanced adenomas \>=16mm found by colonoscopy (as measured at pathology)

Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas \>=5mm (as measured at pathology) RS-: No Advanced adenomas \>=5mm found by colonoscopy (as measured at pathology)
Secondary Objectives

Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"

Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"

Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"

Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"

Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"

Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"

Evaluate interobserver variability in Sensitivity (P(T+\|D+)) and 95% CI) when interpreting CTC examinations Each study was randomly assigned to be read independently using either a primary 2D search method (conventional 2D image display with 3D endoluminal problem solving), or a primary 3D search method (including the capability of displaying multiplanar 2D) and without prior knowledge of the colonoscopy results. A second trained radiologist of similar skill was assigned to read the images using the other modality Readers were then classified as high performing or not high performing

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 14 locations
Suspended
Mayo Clinic ScottsdaleScottsdale, United StatesSee the location
Suspended
Moores UCSD Cancer CenterLa Jolla, United States
Suspended
Jonsson Comprehensive Cancer Center at UCLALos Angeles, United States
Suspended
Veterans Affairs Medical Center - San FranciscoSan Francisco, United States
Completed14 Study Centers