Study of Prognosis of Follicular Lymphoma Through a Prospective Collection of Data (F2-study)

NCT01250223 | Completed

• 1 other identifier: F2-study
• Study Type: observational
• Target: 1,093
• Locations: 8 countries
• Sites: 51

Brief Summary

The F2-study is a complement of the previous studies of the Follicular Lymphoma Prognostic Factors Project which permitted the development of the Follicular Lymphoma International Prognostic Index (FLIPI). The F2-study is designed as a prospective collection of information potentially useful to predict the prognosis of newly diagnosed Follicular Lymphoma patients, and its purposes are to validate the FLIPI and to verify whether a prognostic collection of data would allow the development of a more accurate prognostic index.

Conditions

Lymphoma, Follicular

Keywords

Lymphoma, Follicular; Prognosis; Progression-Free Survival; Outcome; International Cooperation; Data Collection; Prospective studies; Rare Diseases

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  5-year

Secondary Outcomes (3)

• Overall Survival (OS)

  5-year

• Event Free Survival (EFS)

  5-year

• Treatment Free Survival

  5-year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Previously-untreated patients with de novo diagnosis of Follicular Lymphoma according to World Health Organization (WHO) classification (grade 1,2,3a,3b)

You may qualify if:

• Patients with newly diagnosed follicular lymphoma
• Patients with histologically confirmed diagnosis of follicular lymphoma according to WHO classification (any grade)
• Age over 18
• Written informed consent

You may not qualify if:

• None

Sponsors & Collaborators

• Associazione Angela Serra per la ricerca sul cancro: lead
• Fondazione Italiana Linfomi - ETS: collaborator
• The International Non-Hodgkin Lymphoma Prognostic Factor Project: collaborator

Study Sites (51)

Northwestern University Feinberg School of Medicine - Department of Hematology/Oncology

Chicago, Illinois, 60611, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68022, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Academia Nacional de Medicina - Oncohematology Department, Instituto de Investigaciones Hematologicas

Buenos Aires, Argentina

Location

Centro de Internacion e Investigacion Clinica "Angelica Ocampo" - Hematologia

Buenos Aires, Argentina

Location

Charles University General Hospital - Ist Dept Medicine

Prague, Czechia

Location

Centre Hospitalier Universitaire - Hématologie

Besançon, France

Location

Institut Bergonié Comprehensive Cancer Center

Bordeaux, France

Location

Centre Jean Bernard, Clinique Victor Hugo

Le Mans, France

Location

Centre Hospitalier Univeristaire - Hématologie clinique

Nantes, France

Location

Hopital caremeau - Service de Medecine Interne B

Nîmes, France

Location

CHRU Bretonneau - Oncologie medicale

Tours, France

Location

Presidio Spedali Civili

Brescia, BS, 25123, Italy

Location

Azienda Ospedaliera S. Croce e Carle

Cuneo, CN, 12100, Italy

Location

Azienda O.U. Vittorio Emanuele-Ferrarotto-S. Bambino

Catania, CT, 95124, Italy

Location

Azienda Ospedaliera Pugliese-Ciaccio

Catanzaro, CZ, 88100, Italy

Location

Ospedale Casa Sollievo della Sofferenza IRCCS

San Giovanni Rotondo, FG, 71013, Italy

Location

Ospedale unico Versilia USL 12 - Divisione di Medicina II, DH Oncoematologico

Lido di Camaiore, Lucca, Italy

Location

Ospedale San Vincenzo - Ematologia e Immunologia

Taormina, Messina, Italy

Location

Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte

Messina, ME, 98158, Italy

Location

Istituto Clinico Humanitas

Milan, MI, 20089, Italy

Location

Istituto Scientifico Universitario San Raffaele

Milan, MI, 20132, Italy

Location

Istituto Europeo di Oncologia

Milan, MI, 20142, Italy

Location

Ospedale Madonna delle Grazie

Matera, Mount, 75100, Italy

Location

Dipartimento di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Univ. di Modena e Reggio Emilia - Ematologia

Modena, MO, 41100, Italy

Location

Dipartimento di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Univ. di Modena e Reggio Emilia - Medicina Interna

Modena, MO, 41100, Italy

Location

Dipartimento di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Univ. di Modena e Reggio Emilia - Oncologia II

Modena, MO, 41100, Italy

Location

Casa di Cura La Maddalena

Palermo, Pa, 90100, Italy

Location

Ospedale civile Guglielmo da Saliceto - Medicina Oncologica ed Ematologica

Piacenza, PC, Italy

Location

Ospedale Santo Spirito, USL di Pescara - Dipartimento di Oncologia

Pescara, PE, Italy

Location

Policlinico Monteluce - Divisione di Clinica Medica

Perugia, PG, Italy

Location

Azienda Ospedaliera Universitaria Pisana - UO di Ematologia

Pisa, PI, Italy

Location

Fondazione IRCCS Policlinico San Matteo - Clinica Ematologica

Pavia, PV, Italy

Location

Azienda Ospedaliera S. Carlo - Oncologia Medica

Potenza, PZ, Italy

Location

Azienda Ospedaliera Bianchi-Melacrino-Morelli

Reggio Calabria, RC, 89100, Italy

Location

Arcispedale S. Maria Nuova

Reggio Emilia, RE, 42100, Italy

Location

Ospedale E. Morelli - Divisione di Medicina Generale, Ematologia

Sondalo, Sondrio, Italy

Location

Azienda Ospedaliera Universitaria San Giovanni Battista

Torino, TO, 10126, Italy

Location

Policlinico Universitario a gestione diretta - Divisione di Ematologia

Udine, UD, Italy

Location

Ospedale Civile SS. Giovanni e Paolo - UO di Ematologia

Venezia, VE, Italy

Location

Azienda Ospedaliera Maggiore della Carità

Novara, 28100, Italy

Location

Azienda Ospedaliera Sant'Andrea - UOC Ematologia

Roma, Italy

Location

Ospedale Sant'Eugenio - Ematologia

Roma, Italy

Location

Università la Sapienza, Dip. di Biotecnologie Cellulari ed Ematologia, Sez. Ematologia

Roma, Italy

Location

Hospital Universitari Germans Trias i Pujol - Institut Català d'Oncologia

Badalona, Spain

Location

Hospital Clinic - Institut d'Hematologia i Oncologia

Barcelona, Spain

Location

Hospital Universitario Vall de Hebron - Servei d'Hematologia Clinica

Barcelona, Spain

Location

Institu Catala d'Oncologia - Servei d'Hematologia

Girona, Spain

Location

Hospital Clinico Universitario

Valencia, Spain

Location

Ospedale S. Giovanni

Bellinzona, Canton Ticino, 6500, Switzerland

Location

Barths and The London NHS Trust

London, EC1A 7BE, United Kingdom

Location

Related Publications (4)

• Federico M, Bellei M, Pro B, Lopez-Guillermo A, Marcheselli L, Trneny M, Soubeyran P, MCLaughlin P, Pileri S, Solal-Céligny P on behalf of the F2 study. Revalidation of FLIPI in patients with Follicular Lymphoma (FL) registered in the F2 study and treated upfront with immunochemotherapy. J Clin Oncol 25(18s), 2007. Abstr 8008.

  RESULT

• Federico M, Bellei M, Marcheselli L, Luminari S, Lopez-Guillermo A, Vitolo U, Pro B, Martelli M, Soubeyran P, Cortelazzo S, Martinelli G, Pileri S, McLaughlin P, Solal-Céligny P on behalf of International Follicular Lymphoma Prognostic factor Project (IFLPFP) F2-study group. F2 prognostic index. Ann Oncol 19(suppl 4):101-102, 2008. Abstr 058.

  RESULT

• Federico M, Bellei M, Marcheselli L, Luminari S, Lopez-Guillermo A, Vitolo U, Pro B, Pileri S, Pulsoni A, Soubeyran P, Cortelazzo S, Martinelli G, Martelli M, Rigacci L, Arcaini L, Di Raimondo F, Merli F, Sabattini E, McLaughlin P, Solal-Celigny P. Follicular lymphoma international prognostic index 2: a new prognostic index for follicular lymphoma developed by the international follicular lymphoma prognostic factor project. J Clin Oncol. 2009 Sep 20;27(27):4555-62. doi: 10.1200/JCO.2008.21.3991. Epub 2009 Aug 3.

  PMID: 19652063 RESULT

• Solal-Celigny P, Bellei M, Marcheselli L, Pesce EA, Pileri S, McLaughlin P, Luminari S, Pro B, Montoto S, Ferreri AJ, Deconinck E, Milpied N, Gordon LI, Federico M. Watchful waiting in low-tumor burden follicular lymphoma in the rituximab era: results of an F2-study database. J Clin Oncol. 2012 Nov 1;30(31):3848-53. doi: 10.1200/JCO.2010.33.4474. Epub 2012 Sep 24.

  PMID: 23008294 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Formalin-fixed tissue for central diagnostic pathology review

MeSH Terms

Conditions

Lymphoma, Follicular; Rare Diseases

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Massimo Federico, MD

  Dip. Oncologia, Ematologia e Patologie dell'Apparato Respiratorio - Università di Modena e Reggio Emilia, Modena, Italy

  STUDY CHAIR

• Philippe Solal-Céligny, MD

  Centre Jean Bernard, Le Mans, France

  STUDY CHAIR

• Armando Lopez-Guillermo, MD

  Institut d'Hematologia i Oncologia, Hospital Clinic, Barcelona, Spain

  STUDY CHAIR

• Peter McLaughlin, MD

  UT MD Anderson Cancer Ctr, Houston, TX, USA

  STUDY CHAIR

• Umberto Vitolo, MD

  Azienda Universitaria Ospedaliera San Giovanni Battista, Torino, Italy

  STUDY CHAIR

• Stefano A. Pileri, MD

  Instituto Seragnoli, Unità Operativa di Emolinfopatologia, Università di Bologna, Bologna, Italy

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2010
• First Posted: November 30, 2010
• Study Start: February 1, 2003
• Primary Completion: May 1, 2008
• Study Completion: December 1, 2016
• Last Updated: July 9, 2020

Record last verified: 2020-07

Locations

IT (32); FR (6); US (3); CZ (1); GB (1); AR (2); ES (5); CH (1)