NCT05298293Not yet recruiting
Electronic MonitorIng of Events for dIffuse Large b Cell LYmphoma
Evaluation of a Web Application on Event Reporting for Patients With B Lymphoma on First Line Treatment
Source: ClinicalTrials.gov · Last updated 5 Apr 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Diffuse large B cell lymphoma is the most common malignant lymphoid hemopathy. More than half of the patients will be cured with an RCHOP-type immunochemotherapy protocol (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone). Monitoring of adverse effects, risk of relapse and quality of life are essential in overall management. Patients are the best candidates to report them. Managing these events should improve quality of life and reduce costs. The aim of this study is to assess the feasibility of monitoring these events by a web application (Oncolaxy©) and to compare it with a control population in the context of a randomized pilot study including 80 patients per arm with diffuse large cell B lymphoma in first-line treatment with R-CHOP.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 7 Mar 2022
- Start date
- 1 Jul 2022
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Weprom
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT05298293
What you commit to
- Study type: Interventional
- Planned participants: 160
- From 1 Jul 2022 to the primary completion date, 1 Dec 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patient is being treated for another cancer and has not been cured
- Patient with dementia, mental disorders or psychological pathology which could compromise patient informed consent and/or the observance of the study protocol
Other
- Patient with symptomatic brain metastases,
- Patient deprived of their liberty, under guardianship or trusteeship
- Patient cannot submit to the protocol for psychological, social, familial or geographical reasons
- Patient is pregnant or breastfeeding
Who the study is looking for
- Patient with untreated large B cell lymphoma requiring a first line treatment by RCHOP or R-mini-CHOP
- Patient aged 18 years or older at the time of signing Informed Consent Form
- Additional Intrathecal or/and intravenous treatment with Methotrexate allowed, if indicated
- Eastern Cooperative Oncology Group (ECOG) Performance Status \< 3
- Patient with internet access (or has someone at home who can help send patients' symptoms or complete the form)
- Patient enrolled in social security
- Patient has given his written consent ahead of any specific protocol procedure
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Polyclinique Bordeaux Nord Aquitaine Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Clinique Victor Hugo/Centre Jean Bernard/ILC Coordinator of this site? Confirm its status | Le Mans | France | Unknown status |
| Hôpital Privée du Confluent Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Centre Hospitalier de St Nazaire Coordinator of this site? Confirm its status | Saint-Nazaire | France | Unknown status |
| Centre de radiothérapie de Robertsau Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.