Elderly Cancer PatIents, Safety and qualiTy of Life Under immunOtheraPies
NCT ID: NCT03673332
Last Updated: 2026-01-22
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE4
Total Enrollment
40 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-10-16
Study Completion Date
2024-10-29
Brief Summary
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The co-primary objectives will be to assess the safety and quality of life under treatment.
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Detailed Description
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The co-primary objectives will be to assess the safety and quality of life under treatment. Secondary objectives will be evaluations of geriatric data modifications under treatment, efficacy (progression-free survival and overall survival), correlation between toxicity and efficacy, and comparison of the safety profiles between various immunotherapy regimens.
Another secondary objective will be the comparison between patients and clinicians symptom reporting. The investigators will also perform a pharmacokinetics analysis on PD1-monoclonal antibodies to improve the understanding of PD-1 inhibitors pharmacokinetics for the elderly population.
Finally, toxicity and efficacy will be compared to immunological parameters such as the description of tumor infiltrating lymphocytes, markers of immunosenescence and inflammation.
Another secondary objective will be the comparison between patients and clinicians symptom reporting. The investigators will also perform a pharmacokinetics analysis on PD1-monoclonal antibodies to improve the understanding of PD-1 inhibitors pharmacokinetics for the elderly population.
Finally, toxicity and efficacy will be compared to immunological parameters such as the description of tumor infiltrating lymphocytes, markers of immunosenescence and inflammation.
Conditions
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Advanced or Metastatic Melanoma
Advanced or Metastatic NSCLC
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
This is a national prospective phase 4, multi-centre, single arm, open-label cohort study to evaluate the safety and efficacy of immune checkpoint inhibitors-based therapies in elderly patients with advanced or metastatic melanoma or NSCLC.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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treatment including immune checkpoint inhibitors
All patients included in this study will receive approved immune-checkpoint inhibitors therapies, such as CTLA-4, PD-1, and PD-L1 inhibitors.
Group Type
EXPERIMENTAL
immune-checkpoint inhibitors therapies
Intervention Type
DRUG
All patients included in this study will receive approved immune-checkpoint inhibitors therapies, such as CTLA-4, PD-1, and PD-L1 inhibitors.
Interventions
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immune-checkpoint inhibitors therapies
All patients included in this study will receive approved immune-checkpoint inhibitors therapies, such as CTLA-4, PD-1, and PD-L1 inhibitors.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Patients eligible to start a treatment including immune checkpoint inhibitors (Nivolumab, Ipilimumab, Pembrolizumab, and so on…)
* Diagnosis of advanced or metastatic melanoma or NSCLC (All treatment lines will be allowed)
* Age ≥ 70 years
* Having personally signed and dated informed consent
* Patient affiliated to the ''National security'' regimen or beneficiary of this regimen
* Diagnosis of advanced or metastatic melanoma or NSCLC (All treatment lines will be allowed)
* Age ≥ 70 years
* Having personally signed and dated informed consent
* Patient affiliated to the ''National security'' regimen or beneficiary of this regimen
Exclusion Criteria
* Immune checkpoint inhibitor therapy initiated before study enrolment
* Concomitant participation in other investigational clinical trials involving an immune checkpoint inhibitor
* Immune checkpoint inhibitor treatment in a context of other solid tumours
* Immune checkpoint inhibitor treatment in a context of haematological malignancies
* Being unable or unwilling to comply with the requirements of the protocol, as assessed by the investigator
* Patient in urgency situation, adult under legal protection, or unable to give his consent
* Concomitant participation in other investigational clinical trials involving an immune checkpoint inhibitor
* Immune checkpoint inhibitor treatment in a context of other solid tumours
* Immune checkpoint inhibitor treatment in a context of haematological malignancies
* Being unable or unwilling to comply with the requirements of the protocol, as assessed by the investigator
* Patient in urgency situation, adult under legal protection, or unable to give his consent
Minimum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Société Francophone d'Onco-Gériatrie
OTHER
Sponsor Role
collaborator
Institut Paoli-Calmettes
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Renaud Sabatier, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Paoli-Calmettes
Locations
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Assistance Publique des Hôpitaux de Marseille
Marseille, Bouches Du Rhône, France
Site Status
Institut Paoli-Calmettes
Marseille, Bouches-du Rhône, France
Site Status
Institut BERGONIE
Bordeaux, , France
Site Status
CENTRE Francois Baclesse
Caen, , France
Site Status
Centre Georges François Leclerc
Dijon, , France
Site Status
Institut Du Cancer de Montpellier
Montpellier, , France
Site Status
Institut Curie
Paris, , France
Site Status
Institut De Cancérologie de l'Ouest
Saint-Herblain, , France
Site Status
IUCT-Oncopole Institut Claudius Rigaud
Toulouse, , France
Site Status
Countries
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France
References
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Balducci L, Extermann M. Management of cancer in the older person: a practical approach. Oncologist. 2000;5(3):224-37. doi: 10.1634/theoncologist.5-3-224.
Reference Type
BACKGROUND
Basch E, Iasonos A, McDonough T, Barz A, Culkin A, Kris MG, Scher HI, Schrag D. Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study. Lancet Oncol. 2006 Nov;7(11):903-9. doi: 10.1016/S1470-2045(06)70910-X.
Reference Type
BACKGROUND
Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E, Barlesi F, Kohlhaufl M, Arrieta O, Burgio MA, Fayette J, Lena H, Poddubskaya E, Gerber DE, Gettinger SN, Rudin CM, Rizvi N, Crino L, Blumenschein GR Jr, Antonia SJ, Dorange C, Harbison CT, Graf Finckenstein F, Brahmer JR. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. doi: 10.1056/NEJMoa1507643. Epub 2015 Sep 27.
Reference Type
BACKGROUND
Brahmer JR, Tykodi SS, Chow LQ, Hwu WJ, Topalian SL, Hwu P, Drake CG, Camacho LH, Kauh J, Odunsi K, Pitot HC, Hamid O, Bhatia S, Martins R, Eaton K, Chen S, Salay TM, Alaparthy S, Grosso JF, Korman AJ, Parker SM, Agrawal S, Goldberg SM, Pardoll DM, Gupta A, Wigginton JM. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med. 2012 Jun 28;366(26):2455-65. doi: 10.1056/NEJMoa1200694. Epub 2012 Jun 2.
Reference Type
BACKGROUND
Brahmer J, Reckamp KL, Baas P, Crino L, Eberhardt WE, Poddubskaya E, Antonia S, Pluzanski A, Vokes EE, Holgado E, Waterhouse D, Ready N, Gainor J, Aren Frontera O, Havel L, Steins M, Garassino MC, Aerts JG, Domine M, Paz-Ares L, Reck M, Baudelet C, Harbison CT, Lestini B, Spigel DR. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Jul 9;373(2):123-35. doi: 10.1056/NEJMoa1504627. Epub 2015 May 31.
Reference Type
BACKGROUND
Cella D, Grunwald V, Nathan P, Doan J, Dastani H, Taylor F, Bennett B, DeRosa M, Berry S, Broglio K, Berghorn E, Motzer RJ. Quality of life in patients with advanced renal cell carcinoma given nivolumab versus everolimus in CheckMate 025: a randomised, open-label, phase 3 trial. Lancet Oncol. 2016 Jul;17(7):994-1003. doi: 10.1016/S1470-2045(16)30125-5. Epub 2016 Jun 6. Erratum In: Lancet Oncol. 2016 Jul;17(7):e270. doi: 10.1016/S1470-2045(16)30232-7.
Reference Type
BACKGROUND
Champiat S, Dercle L, Ammari S, Massard C, Hollebecque A, Postel-Vinay S, Chaput N, Eggermont A, Marabelle A, Soria JC, Ferte C. Hyperprogressive Disease Is a New Pattern of Progression in Cancer Patients Treated by Anti-PD-1/PD-L1. Clin Cancer Res. 2017 Apr 15;23(8):1920-1928. doi: 10.1158/1078-0432.CCR-16-1741. Epub 2016 Nov 8.
Reference Type
BACKGROUND
Daste A, Domblides C, Gross-Goupil M, Chakiba C, Quivy A, Cochin V, de Mones E, Larmonier N, Soubeyran P, Ravaud A. Immune checkpoint inhibitors and elderly people: A review. Eur J Cancer. 2017 Sep;82:155-166. doi: 10.1016/j.ejca.2017.05.044. Epub 2017 Jul 6.
Reference Type
BACKGROUND
Du-Thanh A, Lesage C, Ferreira E, Dereure O, Guillot B. [Innovative therapies for metastatic melanoma in elderly patients]. Ann Dermatol Venereol. 2015 Oct;142(10):549-56. doi: 10.1016/j.annder.2015.03.022. Epub 2015 May 16. French.
Reference Type
BACKGROUND
Extermann M. Measurement and impact of comorbidity in older cancer patients. Crit Rev Oncol Hematol. 2000 Sep;35(3):181-200. doi: 10.1016/s1040-8428(00)00090-1.
Reference Type
BACKGROUND
Fitzsimmons D, Gilbert J, Howse F, Young T, Arrarras JI, Bredart A, Hawker S, George S, Aapro M, Johnson CD. A systematic review of the use and validation of health-related quality of life instruments in older cancer patients. Eur J Cancer. 2009 Jan;45(1):19-32. doi: 10.1016/j.ejca.2008.07.036. Epub 2008 Sep 25.
Reference Type
BACKGROUND
Greenhalgh J. The applications of PROs in clinical practice: what are they, do they work, and why? Qual Life Res. 2009 Feb;18(1):115-23. doi: 10.1007/s11136-008-9430-6. Epub 2008 Dec 23.
Reference Type
BACKGROUND
Helissey C, Vicier C, Champiat S. The development of immunotherapy in older adults: New treatments, new toxicities? J Geriatr Oncol. 2016 Sep;7(5):325-33. doi: 10.1016/j.jgo.2016.05.007. Epub 2016 Jun 16.
Reference Type
BACKGROUND
Hjermstad MJ, Fayers PM, Bjordal K, Kaasa S. Using reference data on quality of life--the importance of adjusting for age and gender, exemplified by the EORTC QLQ-C30 (+3). Eur J Cancer. 1998 Aug;34(9):1381-9. doi: 10.1016/s0959-8049(98)00136-1.
Reference Type
BACKGROUND
Hua C, Boussemart L, Mateus C, Routier E, Boutros C, Cazenave H, Viollet R, Thomas M, Roy S, Benannoune N, Tomasic G, Soria JC, Champiat S, Texier M, Lanoy E, Robert C. Association of Vitiligo With Tumor Response in Patients With Metastatic Melanoma Treated With Pembrolizumab. JAMA Dermatol. 2016 Jan;152(1):45-51. doi: 10.1001/jamadermatol.2015.2707.
Reference Type
BACKGROUND
Ishida Y, Agata Y, Shibahara K, Honjo T. Induced expression of PD-1, a novel member of the immunoglobulin gene superfamily, upon programmed cell death. EMBO J. 1992 Nov;11(11):3887-95. doi: 10.1002/j.1460-2075.1992.tb05481.x.
Reference Type
BACKGROUND
Khoja L, Day D, Wei-Wu Chen T, Siu LL, Hansen AR. Tumour- and class-specific patterns of immune-related adverse events of immune checkpoint inhibitors: a systematic review. Ann Oncol. 2017 Oct 1;28(10):2377-2385. doi: 10.1093/annonc/mdx286.
Reference Type
BACKGROUND
Lafage-Pochitaloff M, Costello R, Couez D, Simonetti J, Mannoni P, Mawas C, Olive D. Human CD28 and CTLA-4 Ig superfamily genes are located on chromosome 2 at bands q33-q34. Immunogenetics. 1990;31(3):198-201. doi: 10.1007/BF00211556.
Reference Type
BACKGROUND
Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Cowey CL, Lao CD, Schadendorf D, Dummer R, Smylie M, Rutkowski P, Ferrucci PF, Hill A, Wagstaff J, Carlino MS, Haanen JB, Maio M, Marquez-Rodas I, McArthur GA, Ascierto PA, Long GV, Callahan MK, Postow MA, Grossmann K, Sznol M, Dreno B, Bastholt L, Yang A, Rollin LM, Horak C, Hodi FS, Wolchok JD. Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma. N Engl J Med. 2015 Jul 2;373(1):23-34. doi: 10.1056/NEJMoa1504030. Epub 2015 May 31. Erratum In: N Engl J Med. 2018 Nov 29;379(22):2185. doi: 10.1056/NEJMx180040.
Reference Type
BACKGROUND
Manoussakis MN, Tzioufas AG, Silis MP, Pange PJ, Goudevenos J, Moutsopoulos HM. High prevalence of anti-cardiolipin and other autoantibodies in a healthy elderly population. Clin Exp Immunol. 1987 Sep;69(3):557-65.
Reference Type
BACKGROUND
Michelson H, Bolund C, Brandberg Y. Multiple chronic health problems are negatively associated with health related quality of life (HRQoL) irrespective of age. Qual Life Res. 2000;9(10):1093-104. doi: 10.1023/a:1016654621784.
Reference Type
BACKGROUND
Motzer RJ, Escudier B, McDermott DF, George S, Hammers HJ, Srinivas S, Tykodi SS, Sosman JA, Procopio G, Plimack ER, Castellano D, Choueiri TK, Gurney H, Donskov F, Bono P, Wagstaff J, Gauler TC, Ueda T, Tomita Y, Schutz FA, Kollmannsberger C, Larkin J, Ravaud A, Simon JS, Xu LA, Waxman IM, Sharma P; CheckMate 025 Investigators. Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015 Nov 5;373(19):1803-13. doi: 10.1056/NEJMoa1510665. Epub 2015 Sep 25.
Reference Type
BACKGROUND
Naidoo J, Page DB, Li BT, Connell LC, Schindler K, Lacouture ME, Postow MA, Wolchok JD. Toxicities of the anti-PD-1 and anti-PD-L1 immune checkpoint antibodies. Ann Oncol. 2015 Dec;26(12):2375-91. doi: 10.1093/annonc/mdv383. Epub 2015 Sep 14. Erratum In: Ann Oncol. 2016 Jul;27(7):1362. doi: 10.1093/annonc/mdw141.
Reference Type
BACKGROUND
Nghiem PT, Bhatia S, Lipson EJ, Kudchadkar RR, Miller NJ, Annamalai L, Berry S, Chartash EK, Daud A, Fling SP, Friedlander PA, Kluger HM, Kohrt HE, Lundgren L, Margolin K, Mitchell A, Olencki T, Pardoll DM, Reddy SA, Shantha EM, Sharfman WH, Sharon E, Shemanski LR, Shinohara MM, Sunshine JC, Taube JM, Thompson JA, Townson SM, Yearley JH, Topalian SL, Cheever MA. PD-1 Blockade with Pembrolizumab in Advanced Merkel-Cell Carcinoma. N Engl J Med. 2016 Jun 30;374(26):2542-52. doi: 10.1056/NEJMoa1603702. Epub 2016 Apr 19.
Reference Type
BACKGROUND
Reck M, Rodriguez-Abreu D, Robinson AG, Hui R, Csoszi T, Fulop A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O'Brien M, Rao S, Hotta K, Leiby MA, Lubiniecki GM, Shentu Y, Rangwala R, Brahmer JR; KEYNOTE-024 Investigators. Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2016 Nov 10;375(19):1823-1833. doi: 10.1056/NEJMoa1606774. Epub 2016 Oct 8.
Reference Type
BACKGROUND
Rittmeyer A, Barlesi F, Waterkamp D, Park K, Ciardiello F, von Pawel J, Gadgeel SM, Hida T, Kowalski DM, Dols MC, Cortinovis DL, Leach J, Polikoff J, Barrios C, Kabbinavar F, Frontera OA, De Marinis F, Turna H, Lee JS, Ballinger M, Kowanetz M, He P, Chen DS, Sandler A, Gandara DR; OAK Study Group. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet. 2017 Jan 21;389(10066):255-265. doi: 10.1016/S0140-6736(16)32517-X. Epub 2016 Dec 13.
Reference Type
BACKGROUND
Robert C, Karaszewska B, Schachter J, Rutkowski P, Mackiewicz A, Stroiakovski D, Lichinitser M, Dummer R, Grange F, Mortier L, Chiarion-Sileni V, Drucis K, Krajsova I, Hauschild A, Lorigan P, Wolter P, Long GV, Flaherty K, Nathan P, Ribas A, Martin AM, Sun P, Crist W, Legos J, Rubin SD, Little SM, Schadendorf D. Improved overall survival in melanoma with combined dabrafenib and trametinib. N Engl J Med. 2015 Jan 1;372(1):30-9. doi: 10.1056/NEJMoa1412690. Epub 2014 Nov 16.
Reference Type
BACKGROUND
Robert C, Thomas L, Bondarenko I, O'Day S, Weber J, Garbe C, Lebbe C, Baurain JF, Testori A, Grob JJ, Davidson N, Richards J, Maio M, Hauschild A, Miller WH Jr, Gascon P, Lotem M, Harmankaya K, Ibrahim R, Francis S, Chen TT, Humphrey R, Hoos A, Wolchok JD. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med. 2011 Jun 30;364(26):2517-26. doi: 10.1056/NEJMoa1104621. Epub 2011 Jun 5.
Reference Type
BACKGROUND
Solana R, Tarazona R, Gayoso I, Lesur O, Dupuis G, Fulop T. Innate immunosenescence: effect of aging on cells and receptors of the innate immune system in humans. Semin Immunol. 2012 Oct;24(5):331-41. doi: 10.1016/j.smim.2012.04.008. Epub 2012 May 4.
Reference Type
BACKGROUND
Wheelwright S, Darlington AS, Fitzsimmons D, Fayers P, Arraras JI, Bonnetain F, Brain E, Bredart A, Chie WC, Giesinger J, Hammerlid E, O'Connor SJ, Oerlemans S, Pallis A, Reed M, Singhal N, Vassiliou V, Young T, Johnson C. International validation of the EORTC QLQ-ELD14 questionnaire for assessment of health-related quality of life elderly patients with cancer. Br J Cancer. 2013 Aug 20;109(4):852-8. doi: 10.1038/bjc.2013.407. Epub 2013 Jul 18.
Reference Type
BACKGROUND
Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
Reference Type
BACKGROUND
Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
Reference Type
BACKGROUND
Bandeen-Roche K, Xue QL, Ferrucci L, Walston J, Guralnik JM, Chaves P, Zeger SL, Fried LP. Phenotype of frailty: characterization in the women's health and aging studies. J Gerontol A Biol Sci Med Sci. 2006 Mar;61(3):262-6. doi: 10.1093/gerona/61.3.262.
Reference Type
BACKGROUND
Davis HS, MacPherson K, Merry HR, Wentzel C, Rockwood K. Reliability and validity of questions about exercise in the Canadian Study of Health and Aging. Int Psychogeriatr. 2001;13 Supp 1:177-82. doi: 10.1017/s1041610202008128.
Reference Type
BACKGROUND
Cornali C, Franzoni S, Frisoni GB, Trabucchi M. Anorexia as an independent predictor of mortality. J Am Geriatr Soc. 2005 Feb;53(2):354-5. doi: 10.1111/j.1532-5415.2005.53126_4.x. No abstract available.
Reference Type
BACKGROUND
Cheng ST, Chan AC. Comparative performance of long and short forms of the Geriatric Depression Scale in mildly demented Chinese. Int J Geriatr Psychiatry. 2005 Dec;20(12):1131-7. doi: 10.1002/gps.1405.
Reference Type
BACKGROUND
Clement JP, Nassif RF, Leger JM, Marchan F. [Development and contribution to the validation of a brief French version of the Yesavage Geriatric Depression Scale]. Encephale. 1997 Mar-Apr;23(2):91-9. French.
Reference Type
BACKGROUND
Quan H, Li B, Couris CM, Fushimi K, Graham P, Hider P, Januel JM, Sundararajan V. Updating and validating the Charlson comorbidity index and score for risk adjustment in hospital discharge abstracts using data from 6 countries. Am J Epidemiol. 2011 Mar 15;173(6):676-82. doi: 10.1093/aje/kwq433. Epub 2011 Feb 17.
Reference Type
BACKGROUND
Borson S, Scanlan JM, Chen P, Ganguli M. The Mini-Cog as a screen for dementia: validation in a population-based sample. J Am Geriatr Soc. 2003 Oct;51(10):1451-4. doi: 10.1046/j.1532-5415.2003.51465.x.
Reference Type
BACKGROUND
Borson S, Scanlan J, Brush M, Vitaliano P, Dokmak A. The mini-cog: a cognitive 'vital signs' measure for dementia screening in multi-lingual elderly. Int J Geriatr Psychiatry. 2000 Nov;15(11):1021-7. doi: 10.1002/1099-1166(200011)15:113.0.co;2-6.
Reference Type
BACKGROUND
Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.
Reference Type
BACKGROUND
Barberger-Gateau P, Dartigues JF, Letenneur L. Four Instrumental Activities of Daily Living Score as a predictor of one-year incident dementia. Age Ageing. 1993 Nov;22(6):457-63. doi: 10.1093/ageing/22.6.457.
Reference Type
BACKGROUND
KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.
Reference Type
BACKGROUND
Other Identifiers
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2018-002092-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EPITOP-01-IPC 2017-049
Identifier Type: -
Identifier Source: org_study_id
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