Follicular Lymphoma Clinical Trial
Official title:
Towards Personalized Medicine for Refractory/Relapsed Follicular Lymphoma Patients: the Cantera/Lupiae Registry
The optimal treatment strategy in patients with early progressive disease is not well known. In recent years, novel insights into the biology of Follicular Lymphoma (FL), and especially the role of the microenvironment, have resulted in the development of multiple novel treatment modalities. These new agents may ultimately improve the outlook for patients with FL with an unfavorable course, but for the development of the optimal therapeutic strategy, knowledge on the clinical and biological determinants of early refractory FL is needed.
Patients with histologically confirmed follicular lymphoma are registered in the study at the
time of the first event after first line treatment. An event is defined as
refractory/relapsed disease documented by biopsy, imaging, or clinical evaluation.
Registration is based on the locally established histological diagnosis, with exclusion of
cases diagnosed on fine needle aspiration cytology, while tru-cut core-needle biopsies are
permitted in the study. Registration will be done on-line on a key restricted accessible
web-database: the Investigator must complete the on-line registration form after obtaining
informed consent dated and signed by the patient.
Investigators are requested to register consecutive cases diagnosed at each participating
Institution (all patients satisfying Inclusion criteria without any further selection). A
patient number (Patient ID) will be assigned strictly sequentially in ascending order as
patient's eligibility is verified. In case a patient's eligibility is not confirmed and the
patient is withdrawn from the study, the patient number will not be reused. The assigned
number will be used as the identification code for the subject.
Every registered case has to undergo histopathology review by a panel of experts. The
reference pathologist will collect and review the pathology material sent by the
participating centers, without knowledge of the clinical outcome of the patient. Both
material obtained at diagnosis, and at relapse will be reviewed. Classification will be
performed according to the World Health Organization recently published.
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