Geriatric Core Dataset (G-CODE) for Clinical Research in Elderly Cancer Patients

NCT03976531 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2021-01-20

Study results available
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Summary

Older adults with cancer remain underrepresented in cancer clinical trials that establish new standards of care. Geriatric assessment (GA) is defined by geriatricians as a multidimensional interdisciplinary assessment of the general health stat us of the older patient, reviewing the medical, psychosocial, functional and environmental domains. For each domain, several tools are available, but consensus is lacking on which tool to use and the optimal cut-offs or threshold scores. The literature supports the prognostic value of the GA and its utility in weighing the benefits and risks of cancer treatments in older adults. However, GA has not been implemented in routine oncology practice or in cancer clinical trials.

The objective of this project is to develop a set of geriatric data, the Geriatric Core Dataset (G-CODE), to be collected in cancer trials of older patients. The methods rely on a consensus process involving international experts in the field of oncology and geriatrics.

Conditions

Sponsors & Collaborators

  • Plate-forme PACAN (Elderly and Cancer Platform)

    collaborator OTHER
  • European Georges Pompidou Hospital

    collaborator OTHER
  • Hospital Ambroise Paré Paris

    collaborator OTHER
  • Institut Curie

    collaborator OTHER
  • Centre Leon Berard

    collaborator OTHER
  • Institut Claudius Regaud

    collaborator OTHER
  • Saint-Louis Hospital, Paris, France

    collaborator OTHER
  • Hospital Avicenne

    collaborator OTHER
  • Göteborg University

    collaborator OTHER
  • Oslo University Hospital

    collaborator OTHER
  • City of Hope Comprehensive Cancer Center

    collaborator OTHER
  • Institut Bergonié

    lead OTHER

Principal Investigators

  • Simone Mathoulin-Pélissier, MD/PhD · Institut Bergonié

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2017-01-01
Completion
2017-01-01

Countries

  • France

Study Locations

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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 NCT03976531 on ClinicalTrials.gov