Ignite Creation Date:
2024-05-06 @ 1:12 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01754636
Status:
COMPLETED
Last Update Posted:
2017-04-14
First Post:
2012-12-18
Brief Title:
Inclusion of Elderly Patients With Colorectal Cancer in Clinical Trials
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Elderly Patients With Colorectal Cancer in Clinical Trials Factors Associated With Non Inclusion
Status:
COMPLETED
Status Verified Date:
2017-04
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:
SAGE
Brief Summary:
Background Inadequate representation of elderly cancer patients in randomized clinical trials RCTs leading to a lack of external validity thereby an uncertainty regarding benefit-risk balance of cancer treatment in elderly especially chemotherapy
Hypothesis The eligibility criteria explain only a part of the under-representation of elderly patients in trials We make the assumptions that 1 Among the eligible the invitation to participate in a trial and inclusion are inversely related to age 2 Among the eligible there are patients practitioner or organization factors that would explain the non inclusion of elderly patients
Objectives
1 To assess in elderly patients with colorectal cancer the proportions of patients
1 eligible at least to one RCT
2 invited to participate
3 included 2
a Compare proportions among elderly patients to those of the comparator group of young subjects age 18 and 65 years added by amendment n3 accepted 18022014 bTo identify factors associated with the non-invitation and the non-inclusion in RCT
Material and methods
Study design A multicentric prospective cohort survey Population all patients aged 18 years or more added by amendment n3 - 022014 with a colorectal cancer followed in one of the participating centers
Data collection
At baseline Patient characteristics including SOCIO-demographic oncologic and geriatric data will be collected Organization factors eg clinical research team will be collected
Follow-up the patient will be followed for potential invitation and inclusion in one RCT Reasons of non-invitation or non-inclusion will be assessed
Number of subjects needed 696 553 elderly patients and 143 young patients Number of centers 7 added by amendment n3 - 022014
Ethical aspects each patient will give his oral informed consent The International Review Board of Mondor Hospital CPP Ile-de-France IX gave its approval in December 2012
Hypothesis The eligibility criteria explain only a part of the under-representation of elderly patients in trials We make the assumptions that 1 Among the eligible the invitation to participate in a trial and inclusion are inversely related to age 2 Among the eligible there are patients practitioner or organization factors that would explain the non inclusion of elderly patients
Objectives
1 To assess in elderly patients with colorectal cancer the proportions of patients
1 eligible at least to one RCT
2 invited to participate
3 included 2
a Compare proportions among elderly patients to those of the comparator group of young subjects age 18 and 65 years added by amendment n3 accepted 18022014 bTo identify factors associated with the non-invitation and the non-inclusion in RCT
Material and methods
Study design A multicentric prospective cohort survey Population all patients aged 18 years or more added by amendment n3 - 022014 with a colorectal cancer followed in one of the participating centers
Data collection
At baseline Patient characteristics including SOCIO-demographic oncologic and geriatric data will be collected Organization factors eg clinical research team will be collected
Follow-up the patient will be followed for potential invitation and inclusion in one RCT Reasons of non-invitation or non-inclusion will be assessed
Number of subjects needed 696 553 elderly patients and 143 young patients Number of centers 7 added by amendment n3 - 022014
Ethical aspects each patient will give his oral informed consent The International Review Board of Mondor Hospital CPP Ile-de-France IX gave its approval in December 2012
Detailed Description:
None
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