NCT05746858Not yet recruiting
Predictive Biomarkers Including miRNA-based Tumor Signatures in Diffuse Large B Cell Lymphoma (R/R DLBCL) (MIMOSA)
Deciphering the Biology of Relapsed/Refractory Diffuse Large B Cell Lymphoma (R/R DLBCL) Subtypes: Identification of Predictive Biomarkers Including miRNA-based Tumor Signatures to Optimize Sequential Treatment Decisions. (MIMOSA)
Source: ClinicalTrials.gov · Last updated 28 Feb 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this study is to identify biomarkers that will predict outcome to standard and targeted therapies in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The specific aims of the present project are: 1. To explore associations between expression of target antigens on surface of neoplastic cells of DLBCL patients and response to target therapies 2. To identify specific miRNA signatures as predictors of response to upfront and salvage immune-chemotherapies in DLBCL patients. 3. To refine the diagnosis and molecular profiling of DLBCL, and to provide biological information of prognostic relevance in the setting of innovative treatments of patients with DLBCL.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 17 Feb 2023
- Start date
- 1 Apr 2023
- Primary completion date
- 31 Mar 2025
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT05746858
What you commit to
- Study type: Observational
- Planned participants: 300
- From 1 Apr 2023 to the primary completion date, 31 Mar 2025
- 3 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.
Prior treatment
- Patients with concomitant active solid tumors or others clinical conditions that can compromise chemotherapy treatment or negatively influence the prognosis;
Other illness
- No measurable and/or evaluable disease;
- Known history of HIV seropositive status. HIV testing will be performed at screening
Age
- Age ≤ 18 years;
Other
- Diagnosis of follicular lymphoma grade 3b, lymphoblastic lymphoma, Burkitt lymphoma or primary mediastinal lymphoma;
- Ineligible for first-line and/or salvage chemo-immunotherapies;
Who the study is looking for
- Diagnosis of DLBCL and RR-DLBCL;
- Age\>18 years;
- Eligibility for first-line and/or salvage chemo-immunotherapies as above specified;
- Measurable and/or evaluable disease (at least one bi-dimensionally measurable lesion on imaging scan defined as \>1.5 cm in its longest dimension);
- No concomitant active cancers or others life-threatening conditions that can compromise chemotherapy treatment;
- Available FFPE and fresh tumor tissue (excisional biopsy, Tru-cut microhistology);
- Informed consent to treatment and use of biologic materials for studies related to the present proposal.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituto Nazionale Tumori - Fondazione "G.Pascale", IRCCS Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Fonadazione Policlinico Universitario A. Gemelli Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Istituti Fisioterapici Ospitalieri -Istituto Regina Elena Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.