Inclusion of Elderly Patients With Colorectal Cancer in Clinical Trials
NCT ID: NCT01754636
Last Updated: 2017-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
707 participants
OBSERVATIONAL
2012-11-30
2016-11-30
Brief Summary
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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 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:
* At baseline: Patient characteristics (including SOCIO-demographic, oncologic and geriatric data) will be collected. Organization factors (e.g. 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 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Elderly patients
patients aged 65 years old or older : no intervention
No intervention
"Young" patients
patients aged 18-64 years (added by amendment n°3 -02/2014) : no intervention
No intervention
Interventions
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No intervention
Eligibility Criteria
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Inclusion Criteria
For a diagnosed colorectal cancer (CRC) irrespective of the stage
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Locations
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Henri Mondor Hospital
Créteil, Val de Marne, France
Countries
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References
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Aparicio T, Navazesh A, Boutron I, Bouarioua N, Chosidow D, Mion M, Choudat L, Sobhani I, Mentre F, Soule JC. Half of elderly patients routinely treated for colorectal cancer receive a sub-standard treatment. Crit Rev Oncol Hematol. 2009 Sep;71(3):249-57. doi: 10.1016/j.critrevonc.2008.11.006. Epub 2009 Jan 7.
Lewis JH, Kilgore ML, Goldman DP, Trimble EL, Kaplan R, Montello MJ, Housman MG, Escarce JJ. Participation of patients 65 years of age or older in cancer clinical trials. J Clin Oncol. 2003 Apr 1;21(7):1383-9. doi: 10.1200/JCO.2003.08.010.
Canoui-Poitrine F, Lievre A, Dayde F, Lopez-Trabada-Ataz D, Baumgaertner I, Dubreuil O, Brunetti F, Coriat R, Maley K, Pernot S, Tournigand C, Hagege M, Aparicio T, Paillaud E, Bastuji-Garin S. Inclusion of Older Patients with Cancer in Clinical Trials: The SAGE Prospective Multicenter Cohort Survey. Oncologist. 2019 Dec;24(12):e1351-e1359. doi: 10.1634/theoncologist.2019-0166. Epub 2019 Jul 19.
Other Identifiers
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NI 11006
Identifier Type: -
Identifier Source: org_study_id
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