OncologySONGAlpNCT03349229
Geriatric Oncology Follow-up in the Alpine Valley
An observational study of Oncology and Aging, run by University Hospital, Grenoble at 1 site in France.
Trial summary
As the french population is ageing, the question of medical care in elderly cancer patients is fundamental. A third of all cancer patients are 70 years or older. This population has specific challenges: autonomy maintenance, treatments efficacy with limited side effects. Read more about this study
- Who is it for?
- Ages 70 years and older
- How many people
- 4,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2017to 1 Apr 2021
- How long will I take part?
- 48 Months
- 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 patients that are recruited for this study are people over 70 years old, recently diagnosed with cancer. They are the patients in the hospitals that usually treat cancer patients. They have to be evaluated by a geriatrician, either after a clinical evaluation, or after they passed an Oncodage G8 test. This test has been validated in France in 2014, then in the international community (Soubeyran et al.). Ths protocole is for all cancer patients, and any cancer localisation. Even if the treatment is only palliative care, the patients can be in the study. The patients have to live in the following countys: Isère, Haute Savoie, Savoie. The participants need to have a geriatric follow up in one of the centers that participates to the SONGAlp study, between January 2013 and December 2017.
Who may be able to join
- Patients over 70 years old
- Patients diagnosed with cancer (any histologic types)
- Patients amongst the UCOGAlp followup, which includes all patients in the 8 centers that participate
Who cannot join
- Patients under 70 years old
- Patients with no cancer
- Patients that are not amongst the UCOGAlp followup
Trial locations and contacts
1 site in 1 country.
Isabelle MARTY contact
France1 site, 1 recruiting
- Recruiting
CHU Grenoble Alpes
La Tronche, 38700
Gaëtan GAVAZZI, PHD, +33476767575, ggavazzi@chu-grenoble.fr
About this study
Official title: Description and Evaluation of Care Practices Amongst Geriatric Oncology Unit in the Alpine Valley, in the Follow-up of Cancer Patients.
As the french population is ageing, the question of medical care in elderly cancer patients is fundamental. A third of all cancer patients are 70 years or older. This population has specific challenges: autonomy maintenance, treatments efficacy with limited side effects.
As a result of a call to projects, the Geriatric Oncology unit of the French Alps (UCOGAlp) has been selected by the National Institute of Cancer (INCa). It includes 15 centres in the Alpine area. This unit has been evaluated patients since 2011, giving them a full geriatric evaluation and trying to establish adapted cares.
Read more
In order to evaluate the impact of those evaluation on patients' health, the investigators have developped a geriatric follow-up after 1 month (D30) and 4 months (D120).
The investigators want to develop a common data base to these centres, in order to evaluate the care practices that were developped, and demonstrate the benefit for the patient on the dependence level and the overall survival.
Read the detailed description
There is a fundamental question nowadays about elderly cancer patients and how investigators can take care of them best. As the French National Institute for cancer stated, a third of all cancers are diagnosed for people over 70 years old. There are specificities for those patients: autonomy maintenance, treatments efficacy with minimum side effects.
This is why the Alpine Unit for Geriatric Oncology (UCOGAlp) was opened, and answered to a national call to projects. It includes 15 hospitals upon the East side of the Rhone-Alpes state. Since 2012, this unit evaluates, according to geriatric oncology validated tests, cancer patients that are 70 years old and older, so they can benefit from an adequate care plan. The need for a geriatric evaluation is determined by the Oncodage test (G8), or on clinical data.
The investigators wanted to see the impact of those initial evaluations, and so the centres developed follow-ups at day 30 and day 120. Investigators want to create a database that gathers the informations from the centres, to evaluate the care practices that were developed, and prove the benefit of such care for the patients, also on physical dependence and overall survival. This will allow new research paths in the field of geriatric oncology.
This study is an observational descriptive one, multicenter, using prospective data for the geriatric oncology as defined by the UCOGAlp.
It is asking the question of registering care practices in several centres of the Alpine valley that have a geriatric consultation, for elderly cancer patients.
The main outcome is the number of follow-ups of patients at 4 months (D120). The secondary outcomes are the adequation between the treatment that is suggested by a committee, the geriatrician's opinion, and the given treatment, the risk factors associated with dependence, and the overall survival.
The patients that are 70 years and older, recently diagnosed with cancer, are included in the study. They have an initial evaluation of their diseases, the autonomy level, a few biological data (hemoglobin, albumen, renal function), other diseases of the patient (and if they have any effect on his autonomy), the treatment that is chosen by specialists. Then there are the follow-ups with the same questions at D30 and D120. The investigators also want to collect data on overall survival after a 2-year follow-up.
The investigators want the analyze from this data to be the start of many projects in geriatric oncology, whether it is for survival or decision of treatment.
- Keywords
- care practices, geriatry, oncology
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of care practices in geriatric oncology
Change in number of geriatric follow ups at D30 and D120
Measured: 4 months
Secondary outcomes (2)
Dependence of the patients
According to a scale of autonomy that is validated , the Instrumental Activities of Daily Living (ranges from 0 to 8/8, o being no abilities to use any instruments and 8 being able to use all kind), and the Activities of Daily Living (0 to 6/6, 0 is being completely depending on others for every day activities like eating or bathing, 6 is being completely autonomous).
Measured: 4 months
Overall survival according to care decisions
We evaluate the mortality for all causes amongst the patients, with subgroups according to the treatment choices
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start1 Apr 2017
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- 4,000 participants (estimated)
- Target duration
- 48 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaëtan GAVAZZI, PHD, Principal investigator, CHU Grenoble AlpesPascale GUILLEM, PHD, Study director, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349229
- Sponsor's protocol ID
- 38RC16.058
- Other IDs
- 2017-A00434-49
- Acronym
- SONGAlp
- Status last verified
- Nov 2020
- First submitted
- 13 Oct 2017
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description and Evaluation of Care Practices Amongst Geriatric Oncology Unit in the Alpine Valley, in the Follow-up of Cancer Patients.
- ClinicalTrials.gov ID
- NCT03349229
- Acronym / sponsor ID
- SONGAlp / 38RC16.058
- Keywords
- care practices, geriatry, oncology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 21 Nov 2017 (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.
As the french population is ageing, the question of medical care in elderly cancer patients is fundamental. A third of all cancer patients are 70 years or older. This population has specific challenges: autonomy maintenance, treatments efficacy with limited side effects.
As a result of a call to projects, the Geriatric Oncology unit of the French Alps (UCOGAlp) has been selected by the National Institute of Cancer (INCa). It includes 15 centres in the Alpine area. This unit has been evaluated patients since 2011, giving them a full geriatric evaluation and trying to establish adapted cares.
In order to evaluate the impact of those evaluation on patients' health, the investigators have developped a geriatric follow-up after 1 month (D30) and 4 months (D120).
The investigators want to develop a common data base to these centres, in order to evaluate the care practices that were developped, and demonstrate the benefit for the patient on the dependence level and the overall survival.
Detailed description
There is a fundamental question nowadays about elderly cancer patients and how investigators can take care of them best. As the French National Institute for cancer stated, a third of all cancers are diagnosed for people over 70 years old. There are specificities for those patients: autonomy maintenance, treatments efficacy with minimum side effects.
This is why the Alpine Unit for Geriatric Oncology (UCOGAlp) was opened, and answered to a national call to projects. It includes 15 hospitals upon the East side of the Rhone-Alpes state. Since 2012, this unit evaluates, according to geriatric oncology validated tests, cancer patients that are 70 years old and older, so they can benefit from an adequate care plan. The need for a geriatric evaluation is determined by the Oncodage test (G8), or on clinical data.
The investigators wanted to see the impact of those initial evaluations, and so the centres developed follow-ups at day 30 and day 120. Investigators want to create a database that gathers the informations from the centres, to evaluate the care practices that were developed, and prove the benefit of such care for the patients, also on physical dependence and overall survival. This will allow new research paths in the field of geriatric oncology.
This study is an observational descriptive one, multicenter, using prospective data for the geriatric oncology as defined by the UCOGAlp.
It is asking the question of registering care practices in several centres of the Alpine valley that have a geriatric consultation, for elderly cancer patients.
The main outcome is the number of follow-ups of patients at 4 months (D120). The secondary outcomes are the adequation between the treatment that is suggested by a committee, the geriatrician's opinion, and the given treatment, the risk factors associated with dependence, and the overall survival.
The patients that are 70 years and older, recently diagnosed with cancer, are included in the study. They have an initial evaluation of their diseases, the autonomy level, a few biological data (hemoglobin, albumen, renal function), other diseases of the patient (and if they have any effect on his autonomy), the treatment that is chosen by specialists. Then there are the follow-ups with the same questions at D30 and D120. The investigators also want to collect data on overall survival after a 2-year follow-up.
The investigators want the analyze from this data to be the start of many projects in geriatric oncology, whether it is for survival or decision of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 48 Months
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The patients that are recruited for this study are people over 70 years old, recently diagnosed with cancer. They are the patients in the hospitals that usually treat cancer patients. They have to be evaluated by a geriatrician, either after a clinical evaluation, or after they passed an Oncodage G8 test. This test has been validated in France in 2014, then in the international community (Soubeyran et al.). Ths protocole is for all cancer patients, and any cancer localisation. Even if the treatment is only palliative care, the patients can be in the study. The patients have to live in the following countys: Isère, Haute Savoie, Savoie. The participants need to have a geriatric follow up in one of the centers that participates to the SONGAlp study, between January 2013 and December 2017.
Key inclusion criteria (3 listed)
- Patients over 70 years old
- Patients diagnosed with cancer (any histologic types)
- Patients amongst the UCOGAlp followup, which includes all patients in the 8 centers that participate
Key exclusion criteria (3 listed)
- Patients under 70 years old
- Patients with no cancer
- Patients that are not amongst the UCOGAlp followup
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of care practices in geriatric oncology
Time frame: 4 months
Change in number of geriatric follow ups at D30 and D120
2 secondary outcomes
Dependence of the patients
Time frame: 4 months
Overall survival according to care decisions
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
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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.
Isabelle MARTY contact
Gaëtan GAVAZZI, PHD principal investigator
CHU Grenoble Alpes
Pascale GUILLEM, PHD study director
CHU Grenoble Alpes
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 Oncology and Aging, run by University Hospital, Grenoble 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 3 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 13 Nov 2020. 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?
Contact Gaëtan GAVAZZI, PHD (+33476767575, ggavazzi@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of care practices in geriatric oncology (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2020.