NCT03349229

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

4 years

First QC Date

October 13, 2017

Last Update Submit

November 12, 2020

Conditions

Keywords

care practicesgeriatryoncology

Outcome Measures

Primary Outcomes (1)

  • Evaluation of care practices in geriatric oncology

    Change in number of geriatric follow ups at D30 and D120

    4 months

Secondary Outcomes (2)

  • Dependence of the patients

    4 months

  • Overall survival according to care decisions

    2 years

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Patients under 70 years old
  • Patients with no cancer
  • Patients that are not amongst the UCOGAlp followup

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Grenoble Alpes

La Tronche, 38700, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Gaëtan GAVAZZI, PHD

    CHU Grenoble Alpes

    PRINCIPAL INVESTIGATOR
  • Pascale GUILLEM, PHD

    CHU Grenoble Alpes

    STUDY DIRECTOR

Central Study Contacts

Gaëtan GAVAZZI, PHD

CONTACT

Isabelle MARTY

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
48 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2017

First Posted

November 21, 2017

Study Start

April 1, 2017

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations