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Inclusion of Elderly Patients With Colorectal Cancer in Clinical Trials

NCT01754636 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 707

Last updated 2017-04-14

No results posted yet for this study

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 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.

Conditions

Interventions

OTHER

No intervention

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01754636 on ClinicalTrials.gov