Indolent Non Follicular Lymphomas Prognostic Project

Fondazione Italiana Linfomi - ETS

Status: Completed

Conditions: Indolent B-Cell Lymphomas

Treatments: Other: Any treatment, watch and wait policy included

Study type: Observational

Funder types: Other

Identifiers

NCT02904577

NF2010

Details and patient eligibility

About

Prospective collection of data of possible prognostic relevance in patients with indolent non - follicular B-CELL Lymphomas.

Full description

The present study is designed as a prospective collection of information potentially useful to predict the prognosis of newly diagnosed patients with non-follicular low grade B-cell lymphoma.

The study is aimed to verify whether a prognostic collection of data would allow the development of a more accurate prognostic assessment for non-follicular low grade B-cell lymphomas.

Enrollment: 370 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with histologically confirmed diagnosis of non-follicular low grade B-cell lymphoma

   • Splenic MZL (bone marrow histology and/or spleen tissue)
   • Extranodal MZL of MALT (tissue biopsy)
   • Nodal MZL (lymph node biopsy)
   • Lymphocytic lymphoma (lymph node biopsy)
   • Lymphoplasmacytic lymphoma (bone marrow histology or lymph node biopsy)
   • CD5-negative low grade B-cell lymphoma (bone marrow histology)

2. Age over 18

3. Written informed consent

Exclusion criteria

1. None

Trial design

370 participants in 1 patient group

Training and validation cohort

Description:

One cohort: from this cohort 2/3 of patients will be randomly separated after registration in training sample, to develop a prognostic model, and 1/3 in test sample, to validate the prognostic score obtained from the prognostic model. The training cohort aims to develop a prognostic model and a resulting score, on the basis of clinical, biochemical and blood count parameters, in patients with non-follicular indolent lymphomas. Intervention: any treatment, watch and wait policy included The validation cohort is aims to assess the prognostic score on a collected set of data in parallel but independently of the "sample training". Intervention: any treatment, watch and wait policy included

Treatment:

Other: Any treatment, watch and wait policy included