Cancer and / or Hematological MalignancyChimioAgeNCT03960593
Cohort of Patients Over 70 Years of Age With Cancer and / or Hematological Malignancy
An observational study of Cancer and / or Hematological Malignancy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Cancer and / or Hematological Malignancy
- What is being tested?
- Evaluation of the influence of geriatric factors
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2018to 6 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Patients refusing to participate in the research project
- Patients under guardianship or curatorship
- Patients who are not beneficiaries of a social security scheme
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille, 13354
Anne-Laure Couderc, 04.91.74.45.30, anne-laure.couderc@ap-hm.fr
Kahena AMICHI, promotion.interne@ap-hm.fr
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Cancer and / or Hematological Malignancy
- Being tested
- Evaluation of the influence of geriatric factors
- Medical subject headings
- Neoplasms, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the influence of geriatric factorsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Evaluation of the influence of geriatric factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geriatric Assessment (EGS) on Geriatric HDJ
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
Measured: 3-6 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start6 Nov 2018
- Primary completion1 Jan 2019
- Study completion6 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer and / or Hematological MalignancyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960593
- Sponsor's protocol ID
- 2018-56
- Acronym
- ChimioAge
- Status last verified
- May 2019
- First submitted
- 21 May 2019
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Couderc AL, Ninove L, Nouguerede E, Rey D, Rebroin M, Daumas A, Tomasini P, Greillier L, Salas S, Duffaud F, Dahan L, Duluc M, Garcia ME, Pluvy J, Chaleat S, Farnault L, Venton G, Fourie T, Nurtop E, de Lamballerie X, Villani P, Charrel R, Correard F. Acceptance, efficacy, and safety of COVID-19 vaccination in older patients with cancer. J Geriatr Oncol. 2022 Jul;13(6):850-855. doi: 10.1016/j.jgo.2022.05.002. Epub 2022 May 16.
PubMed 35589542
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03960593
- Acronym / sponsor ID
- ChimioAge / 2018-56
- Conditions
- Cancer and / or Hematological Malignancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 6 May 2024 (estimated)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with cancer and / or hematological | – | Other: Evaluation of the influence of geriatric factorsThe 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients refusing to participate in the research project
- Patients under guardianship or curatorship
- Patients who are not beneficiaries of a social security scheme
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of the influence of geriatric factorsFollow-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. | Other | Patients with cancer and / or hematological |
Primary outcome
Geriatric Assessment (EGS) on Geriatric HDJ
Time frame: 3-6 moths
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
- Derived from this study: PubMed 35589542Couderc AL, Ninove L, Nouguerede E, Rey D, Rebroin M, Daumas A, Tomasini P, Greillier L, Salas S, Duffaud F, Dahan L, Duluc M, Garcia ME, Pluvy J, Chaleat S, Farnault L, Venton G, Fourie T, Nurtop E, de Lamballerie X, Villani P, Charrel R, Correard F. Acceptance, efficacy, and safety of COVID-19 vaccination in older patients with cancer. J Geriatr Oncol. 2022 Jul;13(6):850-855. doi: 10.1016/j.jgo.2022.05.002. Epub 2022 May 16.
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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.
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 and / or Hematological Malignancy, run by Assistance Publique Hopitaux De Marseille 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?
The sponsor lists 4 inclusion and 3 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 23 May 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geriatric Assessment (EGS) on Geriatric HDJ (time frame: 3-6 moths). 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 NCT03960593, 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 23 May 2019.