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NCT Number: NCT03976531

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Bergonié, Comprehensive Cancer Center

Bordeaux, France

About this study

Although cancer is prevalent in the older segment of the population, older adults with cancer remain underrepresented in cancer clinical trials that establish new standards of care. As a result, robust data on the benefit/risk balance are lacking for many treatment strategies in these patients.

Ageing is a heterogeneous process that stresses the clinical need to identify comorbid conditions and ageing-related physiologic changes, both well-known factors increasing the risk of treatment side-effects and poor outcomes.

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.

In 2011, after a workshop on clinical trial methodology in older adults with cancer, the Elderly Task Force of the European Organization for Research and Treatment of Cancer (EORTC) recommended the use of a standardised minimum data set (minDS) for assessing the global health and functional status of older populations. This minDS consisted of the G8 screening tool, the Instrumental Activities of Daily Living Following a consensus approach, a panel of 14 geriatricians from oncology clinics identified seven domains of importance in geriatric assessment. Based on the international recommendations, geriatricians selected the mostly commonly used tools/items for geriatric assessment by domain. The Geriatric Core Dataset (G-CODE) was progressively developed according to RAND appropriateness ratings and feedback during three successive Delphi rounds. The face validity of the G-CODE was assessed with two large panels of health professionals (55 national and 42 international experts) involved both in clinical practice and cancer trials.

Who can participate

Only the study team can determine whether someone qualifies for participation.

  • cancer specialists (medical oncologists, surgeons, radiation oncologists, geriatricians, disease-oriented oncologists, clinical oncologists)
  • clinical research associates
  • nurses.

Treatment and study plan

Primary outcomes

  1. Number of Experts Who Considered That the Question "Do You Live Alone ?" Should be Retained in the G-CODE

    Time frame: Day 1

  2. Number of Experts Who Considered That the Question "do You Have a Person or Caregiver Able to Provide Care and Support" Should be Retained in the G-CODE

    Time frame: Day 1

  3. Number of Experts Who Considered That the Tool "ADL (Activities of Daily Living)" Should be Retained in the G-CODE

    Time frame: Day 1

  4. Number of Experts Who Considered That the Tool "4-IADL (Instrumental Activities of Daily Living)" Should be Retained in the G-CODE

    Time frame: Day 1

  5. Number of Experts Who Considered That the Test "Timed Up and Go" Should be Retained in the G-CODE

    Time frame: Day 1

  6. Number of Experts Who Considered That the Items "Weight Loss During the Past 6 Months and Body Mass Index (BMI)" Should be Retained in the G-CODE

    Time frame: Day 1

  7. Number of Experts Who Considered That the Item "One Cognitive Scale (Mini-Cog)" Should be Retained in the G-CODE

    Time frame: Day 1

  8. Number of Experts Who Considered That the Item "Char Lson Comorbidity Index" Should be Retained in the G-CODE

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Collaborators

  • Centre Leon Berard
  • City of Hope Medical Center
  • European Georges Pompidou Hospital
  • Göteborg University
  • Hospital Ambroise Paré Paris
  • Hospital Avicenne
  • Institut Claudius Regaud
  • Institut Curie
  • Oslo University Hospital
  • Plate-forme PACAN (Elderly and Cancer Platform)
  • Saint-Louis Hospital, Paris, France

Registry information

Official study title

Multidisciplinary Development of the Geriatric Core Dataset for Clinical Research in Older Patients With Cancer: A French Initiative With International Survey

Acronym: G-CODE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 6, 2019
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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