NCT02884375|Recruiting
Elderly CAncer Patient
ELCAPA
Elderly Cancer Patient: ELCAPA Cohort Survey
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ELCAPA
Elderly Cancer Patient: ELCAPA Cohort Survey
Sponsor study identifier
observational
3,000
1 country
1
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The management of older patients with cancer has become a major public health concern in Western countries because of the aging of the population and steady increase in cancer incidence with advancing age. Cancer treatment of aged patients is complex due to comorbidities, polypharmacy and functional status. The heterogeneity of the older population in terms of comorbidities and functional status may explain the difficulty in establishing management recommendations. Study hypothesis is that a geriatric consultation using Geriatric Assessment (GA) can evaluate patient's resource and strengths, in order to help oncologist to define the most effective treatment. The GA developed by geriatricians and recommended by the International Society of Geriatric Oncology (SIOG), is a multidimensional assessment of general health status; comorbidities; functional status; nutritional, cognitive, psychological, and social parameters; and medications. The GA uses validated geriatric scales to produce an inventory of problems, which can then serve to develop an individualized geriatric intervention plan; it may be an important step in selecting elderly patients for cancer screening and treatment. The objectives are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
August 18, 2016
Actual (reported)August 31, 2016
Actual (reported)November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Difference between initial oncologist treatment proposal and final treatment selected after geriatric assessment
through multidisciplinary meeting decision, an average of 2 weeks after GA (+/-1 week).
Chemotherapy toxicities using Common Terminology Criteria for Adverse Events
through chemotherapy treatment completion, an average of 6-months after inclusion (+/- 3 months) (according to curative or palliative and chemotherapy protocols).
Feasibility of the planned Chemotherapy treatment (delivery of the planned number of cycles determined based on tumor site and metastatic status)
through chemotherapy treatment completion, an average of 6-months after inclusion (+/- 3 months) (according to curative ou palliative and chemotherapy protocols).
Overall mortality
Year 1 and 5 years follow-up
Patients aged 70 years or older, who had diagnosis of cancer in participating sites (including hematologic malignancies), and referred to a geriatrician for geriatric assessment (GA)
GA includes an evaluation of nine domains according to international recommendations : * functional status (six-item Activities of Daily Living (ADL) score, Instrumental Activities of Daily Living (IADL)) * mobility (timed get-up-and-go test, one-leg standing balance test, history of fall) * nutritional status (French National Authority of Health guidelines, weight loss body mass index (BMI), Mini Nutritional Assessment, albumin ) * cognitive status (Mini-Mental State Examination (MMSE), history of dementia, confusion) * mood (Mini-Geriatric Depression Scale (Mini-GDS), symptoms of anxiety, depression (DSM V)) * comorbidities (CIRS G) * polypharmacy (number of medications) * social environment (primary caregiver, support at home, friends , family, living alone) * urinary and/or fecal incontinence
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All patients aged 70 years or older, who had diagnosis of cancer (including hematologic malignancies), and referred to a getrician for GA in participating sites
Henri Mondor Hospital
Créteil, 94010, France
Couderc AL, Martinez-Tapia C, Mathoulin-Pelissier S, Laurent M, Bringuier M, Gay P, Caillet P, Bertona J, Greillier L, Canovas J, Soubeyran P, Rostoft S, Canoui-Poitrine F, Paillaud E. Using the Geriatric Core Dataset (G-CODE) to predict mortality in older patients with cancer: development and external validation. Br J Cancer. 2026 Oct 12. doi: 10.1038/s41416-026-03641-5. Online ahead of print.
de Salins V, Martinez-Tapia C, Gay P, Morel A, Bringuier M, Boudou-Rouquette P, Corsin L, Aregui A, Canovas J, Rautou PE, Soubeyran P, Bellera C, Canoui-Poitrine F, Paillaud E, Poisson J. The Fibrosis-4 score is associated with overall mortality and severe haematological toxicity in older patients with cancer: Analysis of two prospective cohort studies. Int J Cancer. 2025 Dec 15;157(12):2506-2520. doi: 10.1002/ijc.70071. Epub 2025 Aug 6.
PHILIPPE CAILLET, MD
Assistance Publique - Hôpitaux de Paris
ELENA PAILLAUD, MD-PhD
Assistance Publique - Hôpitaux de Paris
FLORENCE CANOUI-POITRINE, MD-PhD
Assistance Publique - Hôpitaux de Paris
First Submitted
August 18, 2016
First Posted
August 31, 2016
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2027
EstimatedContact the study team to confirm eligibility.
Frasca M, Martinez-Tapia C, Jean C, Chanteclair A, Galvin A, Bergua V, Hagege M, Caillet P, Laurent M, Brain E, Mathoulin-Pelissier S, Paillaud E, Canoui-Poitrine F. Serious Health-Related Suffering Impairs Treatments and Survival in Older Patients With Cancer. J Pain Symptom Manage. 2024 Nov;68(5):506-515.e5. doi: 10.1016/j.jpainsymman.2024.08.002. Epub 2024 Aug 13.
Gonzalez Serrano A, Laurent M, Barnay T, Martinez-Tapia C, Audureau E, Boudou-Rouquette P, Aparicio T, Rollot-Trad F, Soubeyran P, Bellera C, Caillet P, Paillaud E, Canoui-Poitrine F. A Two-Step Frailty Assessment Strategy in Older Patients With Solid Tumors: A Decision Curve Analysis. J Clin Oncol. 2023 Feb 1;41(4):826-834. doi: 10.1200/JCO.22.01118. Epub 2022 Oct 28.
Martinez-Tapia C, Diot T, Oubaya N, Paillaud E, Poisson J, Gisselbrecht M, Morisset L, Caillet P, Baudin A, Pamoukdjian F, Broussier A, Bastuji-Garin S, Laurent M, Canoui-Poitrine F. The obesity paradox for mid- and long-term mortality in older cancer patients: a prospective multicenter cohort study. Am J Clin Nutr. 2021 Jan;113(1):129-141. doi: 10.1093/ajcn/nqaa238. Epub 2020 Sep 5.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 31, 2016
Record last verified: 2016-08
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