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

NCT03976531 | Completed Results

• 1 other identifier: IB2017-GCODE
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Cancer

Keywords

cancer; elderly; randomized trial; consensus

Outcome Measures

Primary Outcomes (8)

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

  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

  Day 1

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

  Day 1

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

  Day 1

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

  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

  Day 1

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

  Day 1

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

  Day 1

Study Arms (1)

Elderly cancer patients included in randomized controlled trials

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Study Sites (1)

Institut Bergonié, Comprehensive Cancer Center

Bordeaux, France

Location

Related Publications (1)

• 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.

  PMID: 30212804 RESULT

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Pr S Mathoulin-Pélissier
• Organization: Institut Bergonié

s.mathoulin@bordeaux.unicancer.fr

33 5 56 33 33 33

Study Officials

• Simone Mathoulin-Pélissier, MD/PhD

  Institut Bergonié

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: June 6, 2019
• Study Start: January 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 20, 2021
• Results First Posted: January 20, 2021

Record last verified: 2020-12

Locations

FR (1)