NCT03976531: G-CODE

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

Completed Results posted Last updated 20 January 2021

What this trial tests

trial in Cancer in 42 participants. Completed in 1 January 2017.

Timeline

1 January 2015

Primary endpoint
1 January 2017

1 January 2017

Quick facts

Lead sponsor	Institut Bergonié
Status	Completed
Study type	OBSERVATIONAL
Enrollment	42
Start date	1 January 2015
Primary completion	1 January 2017
Estimated completion	1 January 2017
Sites	1 location across France

Conditions studied

• Cancer — all drugs for Cancer →

Sponsor

Institut Bergonié — full company profile →

Who can join

18 and older, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
National Panel of Experts	42

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 Primary · Day 1

Group	Value	95% CI
National Panel of Experts	42

Number of Experts Who Considered That the Tool "ADL (Activities of Daily Living)" Should be Retained in the G-CODE Primary · Day 1

Group	Value	95% CI
National Panel of Experts	42

Number of Experts Who Considered That the Tool "4-IADL (Instrumental Activities of Daily Living)" Should be Retained in the G-CODE Primary · Day 1

Group	Value	95% CI
National Panel of Experts	42

Number of Experts Who Considered That the Test "Timed Up and Go" Should be Retained in the G-CODE Primary · Day 1

Group	Value	95% CI
National Panel of Experts	42

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 Primary · Day 1

Group	Value	95% CI
National Panel of Experts	42

Number of Experts Who Considered That the Item "One Cognitive Scale (Mini-Cog)" Should be Retained in the G-CODE Primary · Day 1

Group	Value	95% CI
National Panel of Experts	42

Number of Experts Who Considered That the Item "Char Lson Comorbidity Index" Should be Retained in the G-CODE Primary · Day 1

Group	Value	95% CI
National Panel of Experts	42

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.