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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01754636
First received: December 18, 2012
Last updated: October 29, 2013
Last verified: October 2013
  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. 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 65 years or more 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: 751 Number of centers : 6

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 Randomized controlled Trial [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Eligibility to participate in in at least one Randomized controlled Trial [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • Invitation to participate in in at least one Randomized controlled Trial [ Time Frame: Two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 751
Study Start Date: January 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Elderly patients
65 years old or older, with colorectal cancer
Other: No intervention

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Population: all patients aged 65 years or more with a colorectal cancer followed in one of the participating centers.

Criteria

Inclusion Criteria:

Patient aged of 65 years and older

For a diagnosed colorectal cancer (CRC) irrespective of the stage

Exclusion Criteria:

None

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754636

Contacts
Contact: Florence Canoui-Poitrine, MD, PhD (0) 1.49.81.36.95 ext +33 florence.canouï-poitrine@hmn.aphp.fr
Contact: Laetitia Gregoire (0)1 49 81 41 64 ext +33 laetitia.gregoire@hmn.aphp.fr

Locations
France
Henri Mondor Hospital Recruiting
Creteil, Val de Marne, France, 94010
Contact: Florence Canoui-poitrine, MD, PhD    (0) 1.49.81.36.95 ext +33    florence.canouï-poitrine@hmn.aphp.fr   
Contact: Laetitia Gregoire    (0)1 49 81 41 64 ext +33    laetitia.gregoire@hmn.aphp.fr   
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
Study First Received: December 18, 2012
Last Updated: October 29, 2013
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on July 31, 2014