Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032344
Status:
COMPLETED
Last Update Posted:
2018-08-31
First Post:
2002-03-18
Brief Title:
Long-term Follow-up Study Designed to Evaluate the Relative Risk of Two Colonoscopy Schedules for Patients With Small Polyps
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 380 - Prospective Evaluation of Risk Factors for Large 1 CM Colonic Adenomas in Asymptomatic Subjects
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Colorectal cancer is a leading cause of cancer death in the United States Mortality remains high because most colorectal cancers are detected after there has been regional or distant spread precluding curative surgical resection With this in mind screening strategies have been recommended for asymptomatic individuals which hope to reduce mortality from colon cancer by detecting and removing premalignant adenomatous polyps or early malignant lesions Screening of asymptomatic individuals over age 50 with sigmoidoscopy and fecal occult blood tests has been advocated by the American Cancer Society However current screening will identify only 50 of patients who have adenomatous polyps More sensitive tests for polyp detection like colonoscopy are costly require extensive resources and are unlikely to be used for screening large populations Ideal screening would identify patients with the highest risk of cancer and target more sensitive screening tests at this population The identification of low cost easily collectible risk factors which can be used to target patients for the more sensitive screening tests is the primary purpose of this study Since a major segment of the veteran population is over the age of 50 there will be a substantial impact in reduction of both mortality and morbidity due to colon cancer and attendant cost savings to the VA for treatment if such risk factors can be identified
Phase I is a cross-sectional study designed to identify risk factors for large 1 cm adenomatous polyps Approximately 3200 asymptomatic subjects age 50-75 have completed risk factor assessment medical and dietary histories and have undergone complete colonoscopy examination This will identify for comparison purposes a polyp-free control group and is the first large prospective study to include such a group Data at colonoscopy will characterize the prevalence size and distribution of adenomatous polyps This will permit an assessment of sensitivity of sigmoidoscopy in this population In addition tissue from normal rectal mucosa will be analyzed for evidence of cell proliferation activity The primary focus of Phase I is a risk factor analysis A multivariate analysis will be performed to determine the relationship of historical and environmental factors as well as cell proliferation activity with the presence of adenomatous polyps A cohort consisting of a subgroup of polyp patients large and small and matched polyp-free controls will be tracked longitudinally to determine polyp occurrencerecurrence rates
Phase II of the study is a long-term follow-up study designed to evaluate the relative risk of two repeat colonoscopies
Phase III is an extension in follow-up of an additional five years a total of ten years in all to include all study patients The primary focus will be on documenting long-term mortality and medical outcomes as well as occurrencereoccurrence of neoplasia with special emphasis on ten-year cancer rates
Phase I is a cross-sectional study designed to identify risk factors for large 1 cm adenomatous polyps Approximately 3200 asymptomatic subjects age 50-75 have completed risk factor assessment medical and dietary histories and have undergone complete colonoscopy examination This will identify for comparison purposes a polyp-free control group and is the first large prospective study to include such a group Data at colonoscopy will characterize the prevalence size and distribution of adenomatous polyps This will permit an assessment of sensitivity of sigmoidoscopy in this population In addition tissue from normal rectal mucosa will be analyzed for evidence of cell proliferation activity The primary focus of Phase I is a risk factor analysis A multivariate analysis will be performed to determine the relationship of historical and environmental factors as well as cell proliferation activity with the presence of adenomatous polyps A cohort consisting of a subgroup of polyp patients large and small and matched polyp-free controls will be tracked longitudinally to determine polyp occurrencerecurrence rates
Phase II of the study is a long-term follow-up study designed to evaluate the relative risk of two repeat colonoscopies
Phase III is an extension in follow-up of an additional five years a total of ten years in all to include all study patients The primary focus will be on documenting long-term mortality and medical outcomes as well as occurrencereoccurrence of neoplasia with special emphasis on ten-year cancer rates
Detailed Description:
Primary Hypothesis Risk factors can be determined for large 1 cm adenomas precursor lesions for colorectal cancer
Secondary Hypothesis Determine long-term rates for development or recurrence of polyps determine sensitivityspecificity of current colon cancer screening strategies determine relationship of dietary factors and biomarkers of cell proliferation determine the efficacy and safety of long-term 5 years repeat colonoscopy in patients with small polyps
Intervention Phase I All patients undergo full colonoscopy Phase II Randomization to repeat colonoscopy at 2-3 years and 5 years after baseline or repeat colonoscopy at 5 years only Phase III Ten-year follow-up on all Phase I patients for medical outcomes Repeat colonoscopy at 10 years on polyp-free patients Phase I aged 50-64
Primary Outcomes Presence of risk factors and adenomatous polyps including prevalence descriptive characteristics and long-term occurrencerecurrence rates
Study Abstract Phase I is a cross-sectional study designed to identify risk factors for large 1 cm adenomatous polyps Approximately 3200 asymptomatic subjects age 50-75 have completed risk factor assessment medical and dietary histories and have undergone complete colonoscopy examination This will identify for comparison purposes a polyp-free control group and is the first large prospective study to include such a group Data at colonoscopy will characterize the prevalence size and distribution of adenomatous polyps This will permit an assessment of sensitivity of sigmoidoscopy in this population In addition tissue from normal rectal mucosa will be analyzed for evidence of cell proliferation activity The primary focus of Phase I is a risk factor analysis A multivariate analysis will be performed to determine the relationship of historical and environmental factors as well as cell proliferation activity with the presence of adenomatous polyps A cohort consisting of a subgroup of polyp patients large and small and matched polyp-free controls will be tracked longitudinally to determine polyp occurrencerecurrence rates
Phase II of the study is a long-term follow-up study designed to evaluate the relative risk of two repeat colonoscopy schedules for patients with small polyps identified in Phase I of the study Recruitment is complete with 615 patients eligible of the target 808 assigned at random to either repeat colonoscopy at 2-3 years and 5 years or to repeat colonoscopy at 5 years only This phase will also provide preliminary longitudinal risk factor information related to occurrencerecurrence of polyps
Phase III was a 5-year extension of follow-up period All Phase I patients were to be reconsented to provide medical outcome data for a period of 10 years from baseline exam Phase I patients polyp-free aged 50-64 will be offered repeat colonoscopy at 10 years to evaluate long-term risk
Results Phase I 3121 patients had complete colonoscopy which revealed high rates of neoplasia 375 had one or more neoplastic lesions 105 had advanced neoplasia including 30 cases of invasive cancer 1 There were 37 of patients with no lesions in the rectum or sigmoid colon who had advanced neoplasia elsewhere in the colon 32 of all patients with advanced neoplasia would not be detected with an exam of the rectum or sigmoid colon distal 62 of patients with proximal advanced neoplasia would not be detected with an exam of the rectum and sigmoid colon There were few serious complications 03
The one-time fecal occult blood test FOBT was evaluated as a diagnostic test for advanced neoplasia A positive FOBT indicated an increased likelihood 3-4x of advanced neoplasia However one-time FOBT failed to detect 75 of patients with advanced neoplasia
The primary analysis of risk factors Phase I found positive associations for advanced neoplasia for history of a first degree relative with colorectal cancer OR 166 95 CI 116-235 current smoking OR 185 95 CI 133-258 and current moderate to heavy alcohol use OR 102 95 CI 101-103 Inverse associations were found for cereal fiber intake OR 095 95 CI 091-099 vitamin D intake OR 094 95 CI 090-099 and use of NSAIDs OR 066 95 CI 048-091 Results appeared in JAMA 20032902959-2967
Phase III is completed with patients completing their scheduled follow-ups A major manuscript on the sensitivityspecificity of digital rectal exam appeared in Annals of Internal Medicine January 2005 The Phase II results manuscript appeared in Gastroenterology in October 2007
Secondary Hypothesis Determine long-term rates for development or recurrence of polyps determine sensitivityspecificity of current colon cancer screening strategies determine relationship of dietary factors and biomarkers of cell proliferation determine the efficacy and safety of long-term 5 years repeat colonoscopy in patients with small polyps
Intervention Phase I All patients undergo full colonoscopy Phase II Randomization to repeat colonoscopy at 2-3 years and 5 years after baseline or repeat colonoscopy at 5 years only Phase III Ten-year follow-up on all Phase I patients for medical outcomes Repeat colonoscopy at 10 years on polyp-free patients Phase I aged 50-64
Primary Outcomes Presence of risk factors and adenomatous polyps including prevalence descriptive characteristics and long-term occurrencerecurrence rates
Study Abstract Phase I is a cross-sectional study designed to identify risk factors for large 1 cm adenomatous polyps Approximately 3200 asymptomatic subjects age 50-75 have completed risk factor assessment medical and dietary histories and have undergone complete colonoscopy examination This will identify for comparison purposes a polyp-free control group and is the first large prospective study to include such a group Data at colonoscopy will characterize the prevalence size and distribution of adenomatous polyps This will permit an assessment of sensitivity of sigmoidoscopy in this population In addition tissue from normal rectal mucosa will be analyzed for evidence of cell proliferation activity The primary focus of Phase I is a risk factor analysis A multivariate analysis will be performed to determine the relationship of historical and environmental factors as well as cell proliferation activity with the presence of adenomatous polyps A cohort consisting of a subgroup of polyp patients large and small and matched polyp-free controls will be tracked longitudinally to determine polyp occurrencerecurrence rates
Phase II of the study is a long-term follow-up study designed to evaluate the relative risk of two repeat colonoscopy schedules for patients with small polyps identified in Phase I of the study Recruitment is complete with 615 patients eligible of the target 808 assigned at random to either repeat colonoscopy at 2-3 years and 5 years or to repeat colonoscopy at 5 years only This phase will also provide preliminary longitudinal risk factor information related to occurrencerecurrence of polyps
Phase III was a 5-year extension of follow-up period All Phase I patients were to be reconsented to provide medical outcome data for a period of 10 years from baseline exam Phase I patients polyp-free aged 50-64 will be offered repeat colonoscopy at 10 years to evaluate long-term risk
Results Phase I 3121 patients had complete colonoscopy which revealed high rates of neoplasia 375 had one or more neoplastic lesions 105 had advanced neoplasia including 30 cases of invasive cancer 1 There were 37 of patients with no lesions in the rectum or sigmoid colon who had advanced neoplasia elsewhere in the colon 32 of all patients with advanced neoplasia would not be detected with an exam of the rectum or sigmoid colon distal 62 of patients with proximal advanced neoplasia would not be detected with an exam of the rectum and sigmoid colon There were few serious complications 03
The one-time fecal occult blood test FOBT was evaluated as a diagnostic test for advanced neoplasia A positive FOBT indicated an increased likelihood 3-4x of advanced neoplasia However one-time FOBT failed to detect 75 of patients with advanced neoplasia
The primary analysis of risk factors Phase I found positive associations for advanced neoplasia for history of a first degree relative with colorectal cancer OR 166 95 CI 116-235 current smoking OR 185 95 CI 133-258 and current moderate to heavy alcohol use OR 102 95 CI 101-103 Inverse associations were found for cereal fiber intake OR 095 95 CI 091-099 vitamin D intake OR 094 95 CI 090-099 and use of NSAIDs OR 066 95 CI 048-091 Results appeared in JAMA 20032902959-2967
Phase III is completed with patients completing their scheduled follow-ups A major manuscript on the sensitivityspecificity of digital rectal exam appeared in Annals of Internal Medicine January 2005 The Phase II results manuscript appeared in Gastroenterology in October 2007
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None