An observational study in Colorectal Cancer, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-14.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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:
a) Compare proportions among elderly patients to those of the comparator group of "young" subjects (age ≥ 18 and \<65 years) (added by amendment n°3 accepted 18/02/2014) b)To 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 n°3 - 02/2014) with a colorectal cancer followed in one of the participating centers.
Data collection:
Number of subjects needed: 696 (553 elderly patients and 143 "young" patients) Number of centers : 7 (added by amendment n°3 - 02/2014)
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 707 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Population: all patients aged 18 years or more with a colorectal cancer followed in one of the participating centers (amendment n°3 - 02/2014)
Patient aged of of 18 years and older (modified by amendment n°3 - 02/2014)
For a diagnosed colorectal cancer (CRC) irrespective of the stage
Exclusion Criteria:
None
patients aged 65 years old or older : no intervention
Other: No intervention
patients aged 18-64 years (added by amendment n°3 -02/2014) : no intervention
Other: No intervention
Inclusion in at least one Clinical trial (amendment n°3 -02/2014)
Time frame: At the end of recruiting period (nov. 2012 - nov. 2016)
Eligibility to participate in in at least one Clinical trial (amendment n°3 -02/2014)
Time frame: Four years
Invitation to participate in in at least one Clinical trial (amendment n°3 -02/2014)
Time frame: Four years
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris