Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05720910 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Streamlined Geriatric and Oncological Evaluation Based On IC Technology

Study acronym: FRONE
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 35 words
    • Secondary endpoints: details revised at 3 of 14 entries
    • Publications: details revised at 1 of 1 entry
  2. Trial status changed: Recruiting → Active, Not Recruiting
    • Primary completion moved earlier from Apr 2027 to Oct 2026
    • Study sites: 10 to 11
    • Study completion date: Apr 2027 to Apr 14, 2027
    v4
  3. Study sites: 8 to 10v3
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 7 more changesShow less
    • Primary completion date: Aug 2025 to Apr 2027
    • Start date changed from estimate of Apr 2023 to Oct 15, 2024
    • Study sites: 0 to 8
    • Study completion date: Jan 2026 to Apr 2027
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 1 of 14 entries
    • Study description expanded, about 1 word
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Institut Bergonié
40 trials monitored
See 1 trial at risk
Breast Cancer
5,418 trials monitored
See 296 trials at risk
Lung Cancer
4,790 trials monitored
See 263 trials at risk
Colorectal Cancer
3,394 trials monitored
See 159 trials at risk
and 1 more disease
The primary objective of GERONTE STUDY is to evaluate the effectiveness of the GERONTE, ICT-based, integrated care pathway to improve patient 6-month quality of life, in France. Study design is a stepped wedge randomised controlled trial. Clusters will be participating hospitals, comprising eight investigating sites in total (Figure 2). This is a stepped wedge of cross-over type. Patients included at each "step" are different individuals. The first "step" is a reference measurement where none of the clusters will implement the intervention. The investigating sites will be randomly drawn to determine the order in which they will implement the intervention, by "steps" of two months. The primary endpoint is the Quality of Life assessed by the EORTC QLQ-C30 (version 3.0) questionnaire at 6 months after GERONTE implementation. It has 3 sub-scores that will be analysed independently, with alpha risk adjustment.
Trial Details
NCT Number NCT05720910
Lead Sponsor Institut Bergonié
Collaborators: EUCLID Clinical Trial Platform, University of Bordeaux
Conditions
(from sponsor)		 Breast Cancer, Comorbidities and Coexisting Conditions, Lung Cancer, Colorectal Cancer, Prostate Cancer
Related terms Breast Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Prostatic Neoplasms
Enrollment 720 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov