- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03960593
Cohort of Patients Over 70 Years of Age With Cancer and / or Hematological Malignancy (ChimioAge)
Cohort of Patients> 70 Years Old With Cancer and / or Hematological Malignancy Treated With Chemotherapy and / or Immunotherapy and / or Targeted Therapy and / or New Generation Hormone Therapy After Oncogeriatric Evaluation and Therapeutic Revision on Public Assistance -Hospitals From Marseille
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aging of the French population is associated with a constant increase in the number of cancers in people over 75 years of age (1/3 of cancers diagnosed in patients ≥ 75 years).
Oncogeriatrics is a combination of two specialties, oncology and geriatrics. This practice aims to ensure that all elderly cancer patients are treated according to their condition through a multidisciplinary and multiprofessional approach. The improvement of the care of elderly people with cancer has been measured in Measure 23.4 of the 2009-2013 Cancer Plan. This objective is pursued through action 2.16 of the 2014-2019 Cancer Plan aimed at meeting the specific needs of elderly people with cancer, notably by relying on the organizational set-up of UCOGs (Coordination Units in Onco-Geriatrics). for an improvement of the management practices of this population and a structuring of clinical research in oncogeriatrics.
However, 85% of people over 75 have at least one pathology and more than 7 different molecules are delivered on average at least three times a year. Polypharmacy is a factor of frailty and the risk of functional decline is established from two prescribed drugs. Polypharmacy can be problematic in elderly patients with cancer who are treated with chemotherapy.
In our institution, we wanted to combine a review of therapies with this geriatric evaluation in elderly patients with cancer or haematological diseases managed by a systemic oncological treatment. In this context, during the evaluation sessions in day hospital (HDJ) of oncogeriatrics on the Assistance Publique-Hopitaux de Marseille (AP-HM), a medical assessment and a cross analysis between the usual treatments of patients (herbal medicine) and self-medication) and chemotherapy and / or immunotherapy and / or targeted therapy and / or new generation hormone therapy are routinely performed. The main objective of this work is to evaluate the influence of the therapeutic revisions associated with the EGS data on the unplanned hospitalization rate at 3 months and then the secondary objective of the impact on the course of treatment oncology, to become patients and their survival. For this purpose, we want to conduct a pilot observational cohort study, monocentric, prospective, descriptive for patients convened in oncogeriatric HDJ and each patient is followed for 6 months.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Marseille, France, 13354
- Recruiting
- Assistance Publique Hopitaux de Marseille
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Contact:
- Anne-Laure Couderc
- Phone Number: 04.91.74.45.30
- Email: anne-laure.couderc@ap-hm.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subjects over the age of 70 with an Oncoding score less than or equal to 14
- Patients receiving social security benefits
- suffering from cancerous pathology whatever the stage / grade and the associated comorbidities treated by chemotherapy and / or targeted therapy and / or immunotherapy and / or new generation hormone therapy
- Having read, understood and signed the non-opposition form
Exclusion Criteria:
- Patients refusing to participate in the research project
- Patients under guardianship or curatorship
- Patients who are not beneficiaries of a social security scheme
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with cancer and / or hematological
The population of the study will be all patients over 70 years of age with oncogeriatric HDJ cancer prior to initiation of oncologic therapy such as chemotherapy (oral or intravenous) and / or targeted therapy and / or immunotherapy and / or hormone therapy.
new generation.
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Follow-up of patients> 70 years old with cancer pathologies to evaluate the influence of geriatric factors associated with a review of therapies on their care pathways and health conditions.
We will be particularly interested in the main objective, the unplanned hospitalization rate at 3 months in patients> 70 years old with cancer treated in oncogeriatric HDJ before the initiation of oncological treatment such as chemotherapy (oral or intravenous) and / or targeted therapy and / or immunotherapy and / or new generation hormone therapy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geriatric Assessment (EGS) on Geriatric HDJ
Time Frame: 3-6 moths
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Inclusion in HDJ and geriatric frailty collection (EGS) by the geriatrician in HDJ.
Evaluation by pharmacist and collection in HDJ of the usual treatment, phytotherapy, future oncological treatment administered.
Geriatric and pharmaceutical report in 24 hours sent to the treating physician and oncologist
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3-6 moths
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-56
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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