2023-504342-55-00CompletedPhase 2/3
Interventional Platform Study Investigating the Impact of Digital Health Solutions on Health Outcomes and Health-Care Resource Utilization in Participants Receiving Systemic Treatment in Clinical Practice (ORIGAMA)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 27 Feb 2024
Brief summary (registry, in English)
Cohort A • To demonstrate superiority of the Roche digital patient monitoring (DPM) atezolizumab Module on symptom interference Cohort B • To evaluate the feasibility of combining the Roche DPM Atezolizumab Module and Atezolizumab subcutaneous (SC) administered in the at home treatment setting
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 90 (actual)
- First submitted
- 12 Dec 2023
- Start date
- 2 Feb 2023
- Lead sponsor
- F. Hoffmann-La Roche AG
- EU CT number
- 2023-504342-55-00
- EudraCT number
- 2021-001415-90
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 90
- 13 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Cohort A Concomitant anti-cancer therapy at the time of starting atezolizumab (IV) regimen on the index date which is not part of a locally approved combination therapy with atezolizumab as per summary of product characteristics (SmPC) or local regulatory documents
Other illness
- Participants with any physical or cognitive condition that, according to clinical judgment, would prevent the participant from using the Digital Health Solution (DHS)
- Participants not proficient with any of the available DHS language translations or with psychiatric/neurologic disorders or any condition that may impact the participant's ability to use the DHS
- Cohort B History of malignancy within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
Lab values
- Cohort B Participants known to have a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene
Other
- Participants currently enrolled in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study
Who the study is looking for
- Participant has an email address, access to an internet-capable device, and access to an internet connection
- Cohort A Participants must have a histologically confirmed diagnosis via local labs
- Cohort A Eastern cooperative oncology group (ECOG) performance status of 0, 1, or 2 Cohort B ECOG Performance Status of 0 or 1
- Cohort A Life expectancy >= 12 weeks
- Cohort B Participants must have a complete resection of a histologically or cytologically confirmed Stage IIB-IIIB (T3-N2) non-small cell lung carcinoma (NSCLC)
- Cohort B Programmed cell death-ligand 1 (PD-L1) positive as documented through local testing performed per manufacturer’s recommendations and requirements of a representative tumor tissue specimen. An appropriate CE marked or In-Vitro Diagnostics Device approved test should be used for local testing of PD-L1.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz | Graz | Austria | Completed |
| Landeskrankenanstalten-Betriebsgesellschaft Kabeg | Klagenfurt Am Woerthersee | Austria | Completed |
| Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg | Aschaffenburg | Germany | Completed |
| Klinik Dr. Hancken GmbH | Stade | Germany | Completed |
| Praxisnetzwerk Hämatologie und internistische Onkologie | Troisdorf | Germany | Completed |
| Helios Universitaetsklinikum Wuppertal | Wuppertal | Germany | Completed |
| Hospital Clinic de Barcelona | Barcelona | Spain | Completed |
| Hospital del Mar | Barcelona | Spain | Completed |
| Hospital Universitario de Jaén | Jaén | Spain | Completed |
| Hospital Universitario Regional de Málaga | Málaga | Spain | Completed |
| Hospital Son Llatzer | Palma | Spain | Completed |
| Hospital General Universitario de Valencia | Valencia | Spain | Completed |
| Hospital Unviersitario Miguel Servet | Zaragoza | Spain | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.