CancerG-CODENCT03976531
Geriatric Core Dataset (G-CODE) for Clinical Research in Elderly Cancer Patients
An observational study of Cancer, run by Institut Bergonié at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2015to 1 Jan 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The panel of experts (cancer specialists, clinical research associates, nurses) was in charge of assessing the the relevance and approppriateness of the selected tools to include in the Geriatric Core Data Set (G-Code).
- cancer specialists (medical oncologists, surgeons, radiation oncologists, geriatricians, disease-oriented oncologists, clinical oncologists)
- clinical research associates
- nurses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multidisciplinary Development of the Geriatric Core Dataset for Clinical Research in Older Patients With Cancer: A French Initiative With International Survey
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.
Read the detailed description
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.
- Conditions
- Cancer
- Keywords
- cancer, elderly, randomized trial, consensus
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elderly cancer patients included in randomized controlled trials | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Experts Who Considered That the Question "Do You Live Alone ?" Should be Retained in the G-CODE
Measured: Day 1
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
Measured: Day 1
Number of Experts Who Considered That the Tool "ADL (Activities of Daily Living)" Should be Retained in the G-CODE
Measured: Day 1
Number of Experts Who Considered That the Tool "4-IADL (Instrumental Activities of Daily Living)" Should be Retained in the G-CODE
Measured: Day 1
Number of Experts Who Considered That the Test "Timed Up and Go" Should be Retained in the G-CODE
Measured: Day 1
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
Measured: Day 1
Number of Experts Who Considered That the Item "One Cognitive Scale (Mini-Cog)" Should be Retained in the G-CODE
Measured: Day 1
Number of Experts Who Considered That the Item "Char Lson Comorbidity Index" Should be Retained in the G-CODE
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start1 Jan 2015
- Primary completion1 Jan 2017
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- Plate-forme PACAN (Elderly and Cancer Platform), European Georges Pompidou Hospital, Hospital Ambroise Paré Paris, Institut Curie, Centre Leon Berard, Institut Claudius Regaud, Saint-Louis Hospital, Paris, France, Hospital Avicenne, Göteborg University, Oslo University Hospital, City of Hope Medical Center
- Responsible party
- Sponsor
- Investigators
- Simone Mathoulin-Pélissier, MD/PhD, Principal investigator, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976531
- Sponsor's protocol ID
- IB2017-GCODE
- Acronym
- G-CODE
- Status last verified
- Dec 2020
- First submitted
- 23 May 2019
- Last updated
- 20 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Paillaud E, Soubeyran P, Caillet P, Cudennec T, Brain E, Terret C, Etchepare F, Mourey L, Aparicio T, Pamoukdjian F, Audisio RA, Rostoft S, Hurria A, Bellera C, Mathoulin-Pelissier S; G-CODE collaborators. Multidisciplinary development of the Geriatric Core Dataset for clinical research in older patients with cancer: A French initiative with international survey. Eur J Cancer. 2018 Nov;103:61-68. doi: 10.1016/j.ejca.2018.07.137. Epub 2018 Sep 11.
PubMed 30212804
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Development of the Geriatric Core Dataset for Clinical Research in Older Patients With Cancer: A French Initiative With International Survey
- ClinicalTrials.gov ID
- NCT03976531
- Acronym / sponsor ID
- G-CODE / IB2017-GCODE
- Conditions
- Cancer
- Keywords
- cancer, elderly, randomized trial, consensus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- Plate-forme PACAN (Elderly and Cancer Platform), European Georges Pompidou Hospital, Hospital Ambroise Paré Paris, Institut Curie, Centre Leon Berard, Institut Claudius Regaud, Saint-Louis Hospital, Paris, France, Hospital Avicenne, Göteborg University, Oslo University Hospital, City of Hope Medical Center
- Study start
- 1 Jan 2015
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 6 Jun 2019 (actual)
- Results
- Posted 20 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly cancer patients included in randomized controlled trials | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The panel of experts (cancer specialists, clinical research associates, nurses) was in charge of assessing the the relevance and approppriateness of the selected tools to include in the Geriatric Core Data Set (G-Code).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Experts Who Considered That the Question "Do You Live Alone ?" Should be Retained in the G-CODE
Time frame: Day 1
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
Number of Experts Who Considered That the Tool "ADL (Activities of Daily Living)" Should be Retained in the G-CODE
Time frame: Day 1
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
Number of Experts Who Considered That the Test "Timed Up and Go" Should be Retained in the G-CODE
Time frame: Day 1
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
Number of Experts Who Considered That the Item "One Cognitive Scale (Mini-Cog)" Should be Retained in the G-CODE
Time frame: Day 1
Number of Experts Who Considered That the Item "Char Lson Comorbidity Index" Should be Retained in the G-CODE
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30212804Paillaud E, Soubeyran P, Caillet P, Cudennec T, Brain E, Terret C, Etchepare F, Mourey L, Aparicio T, Pamoukdjian F, Audisio RA, Rostoft S, Hurria A, Bellera C, Mathoulin-Pelissier S; G-CODE collaborators. Multidisciplinary development of the Geriatric Core Dataset for clinical research in older patients with cancer: A French initiative with international survey. Eur J Cancer. 2018 Nov;103:61-68. doi: 10.1016/j.ejca.2018.07.137. Epub 2018 Sep 11.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone Mathoulin-Pélissier, MD/PhD principal investigator
Institut Bergonié
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Institut Bergonié at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Experts Who Considered That the Question "Do You Live Alone ?" Should be Retained in the G-CODE (time frame: Day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03976531, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.