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Inclusion of Elderly Patients With Colorectal Cancer in Clinical Trials (SAGE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01754636
First Posted: December 21, 2012
Last Update Posted: April 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose

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 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.


Condition Intervention
Colorectal Cancer Other: No intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Elderly Patients With Colorectal Cancer in Clinical Trials: Factors Associated With Non Inclusion

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Inclusion in at least one Clinical trial (amendment n°3 -02/2014) [ Time Frame: At the end of recruiting period (nov. 2012 - nov. 2016) ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 707
Actual Study Start Date: November 2012
Study Completion Date: November 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Elderly patients
patients aged 65 years old or older : no intervention
Other: No intervention
"Young" patients
patients aged 18-64 years (added by amendment n°3 -02/2014) : no intervention
Other: No intervention

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Population: all patients aged 18 years or more with a colorectal cancer followed in one of the participating centers (amendment n°3 - 02/2014)
Criteria

Inclusion Criteria:

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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754636


Locations
France
Henri Mondor Hospital
Creteil, Val de Marne, France, 94010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01754636     History of Changes
Other Study ID Numbers: NI 11006
First Submitted: December 18, 2012
First Posted: December 21, 2012
Last Update Posted: April 14, 2017
Last Verified: April 2017

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Colorectal neoplasms
Elderly
Randomized clinical trials
Inclusion.

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases