Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007618
Status:
COMPLETED
Last Update Posted:
2011-02-03
First Post:
2000-12-29
Brief Title:
The Identification of Prognostic Factors of Late Stage Disease Particularly Those That Are Modifiable That Might Explain the Worsened Prognosis With Colorectal Cancer Among Veterans
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 707D - Colorectal Cancer-Risk Factors for Advanced Disease
Status:
COMPLETED
Status Verified Date:
2011-02
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 the second leading cause of cancer death in the United States each year Approximately one million veterans aged 50 and older will develop colorectal cancer over the remainder of their lives and nearly 433000 will die from it Because most cancers are diagnosed after local or regional spread nearly half of all patients diagnosed with colorectal cancer will die On a national basis the relative five year survival with colorectal cancer was estimated at approximately 40 among veterans substantially lower than SEER estimates in the general population of 617 colon and 593 rectum Colorectal cancer is preventable through screening however and if diagnosed in an early stage Dukes A and B is curable
This is the first study to examine factors that might explain the worsened prognosis for veterans with colorectal cancer If modifiable factors such as physician and patient delay in diagnosis or poverty explain the increased mortality among veterans educational programs and interventions that improve the process of care associated with screening and diagnosis can be instituted
This is the first study to examine factors that might explain the worsened prognosis for veterans with colorectal cancer If modifiable factors such as physician and patient delay in diagnosis or poverty explain the increased mortality among veterans educational programs and interventions that improve the process of care associated with screening and diagnosis can be instituted
Detailed Description:
Primary Objectives To identify prognostic factors of late stage disease particularly those that are modifiable that might explain the worsened prognosis with colorectal cancer among veterans and that also might be responsive to intervention Interventions directed at these factors could lead to a decreased mortality among veterans
Secondary Objectives To compare outcomes among veterans with similar non-veterans who are participating in the NCI-funded study Population Study of Colon Cancer in Blacks and Whites that is in-progress at the University of North Carolina at Chapel Hill
Primary Outcomes The primary outcomes are stage of disease and delay of diagnosis Delay of diagnosis is determined by length of time between symptom onset and medical consultation patient delay and length of time between first seeking medical consultation and diagnosis physician or system delay Stage of disease will be used as a proxy for survival
Intervention NA
Study Abstract Colorectal cancer is the second leading cause of cancer death in the United States each year Approximately one million veterans aged 50 and older will develop colorectal cancer over the remainder of their lives and nearly 433000 will die from it Because most cancers are diagnosed after local or regional spread nearly half of all patients diagnosed with colorectal cancer will die On a national basis the relative five year survival with colorectal cancer was estimated at approximately 40 among veterans substantially lower than SEER estimates in the general population of 617 colon and 593 rectum Colorectal cancer is preventable through screening however and if diagnosed in an early stage Dukes A and B is curable
This is the first study to examine factors that might explain the worsened prognosis for veterans with colorectal cancer If modifiable factors such as physician and patient delay in diagnosis or poverty explain the increased mortality among veterans educational programs and interventions that improve the process of care associated with screening and diagnosis can be instituted
To-date 659 subjects have been enrolled Study participation involves obtaining demographic pathology and patient contact data on all colorectal cancer patients at the 14 participating sites and conducting a one-time telephone interview Preliminary study data suggests that most veterans with colorectal cancer present with evidence of regional or distant spread of their colorectal cancer No significant difference in stage at presentation among veterans versus the population-based SEER patients is evident Fewer veterans present with localized disease 33 versus 40 and although not statistically significant could suggest a trend toward presentation at a more advanced stage
Results of this study will provide a profile of patients at high-risk of presenting with advanced colorectal cancer This profile may be useful in designing patient and health care system focused interventions to improve stage at diagnosis
Final Results Analyses are underway A Final Report will be submitted to Durham ERIC within 90 days of study end date 033102
Secondary Objectives To compare outcomes among veterans with similar non-veterans who are participating in the NCI-funded study Population Study of Colon Cancer in Blacks and Whites that is in-progress at the University of North Carolina at Chapel Hill
Primary Outcomes The primary outcomes are stage of disease and delay of diagnosis Delay of diagnosis is determined by length of time between symptom onset and medical consultation patient delay and length of time between first seeking medical consultation and diagnosis physician or system delay Stage of disease will be used as a proxy for survival
Intervention NA
Study Abstract Colorectal cancer is the second leading cause of cancer death in the United States each year Approximately one million veterans aged 50 and older will develop colorectal cancer over the remainder of their lives and nearly 433000 will die from it Because most cancers are diagnosed after local or regional spread nearly half of all patients diagnosed with colorectal cancer will die On a national basis the relative five year survival with colorectal cancer was estimated at approximately 40 among veterans substantially lower than SEER estimates in the general population of 617 colon and 593 rectum Colorectal cancer is preventable through screening however and if diagnosed in an early stage Dukes A and B is curable
This is the first study to examine factors that might explain the worsened prognosis for veterans with colorectal cancer If modifiable factors such as physician and patient delay in diagnosis or poverty explain the increased mortality among veterans educational programs and interventions that improve the process of care associated with screening and diagnosis can be instituted
To-date 659 subjects have been enrolled Study participation involves obtaining demographic pathology and patient contact data on all colorectal cancer patients at the 14 participating sites and conducting a one-time telephone interview Preliminary study data suggests that most veterans with colorectal cancer present with evidence of regional or distant spread of their colorectal cancer No significant difference in stage at presentation among veterans versus the population-based SEER patients is evident Fewer veterans present with localized disease 33 versus 40 and although not statistically significant could suggest a trend toward presentation at a more advanced stage
Results of this study will provide a profile of patients at high-risk of presenting with advanced colorectal cancer This profile may be useful in designing patient and health care system focused interventions to improve stage at diagnosis
Final Results Analyses are underway A Final Report will be submitted to Durham ERIC within 90 days of study end date 033102
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