This is a multi-institutional retrospective study in order to identify the most relevant and advisable features of follow-up, and to explore its impact on principal clinical outcomes. Moreover, a dedicated effort will be pursued to identify the peculiar characteristics (if any) of patients that experienced recurrence of the disease. The study will collect data about patients affected by primary GIST at very-low and low risk of recurrence/progression, referred to participating Institutions between January 2000 and February 2020
In the field of soft tissue sarcomas, Gastrointestinal Stromal Tumors (GIST) represents a really peculiar neoplasm for its biological and clinical properties. Surgery (if feasible) is the main therapeutic approach for all the patients with localized disease, while a pharmacological adjuvant treatment is reserved to those with a relevant risk of recurrence/progression. After tumor removal, clinical and radiological follow-up is of central importance to early intercept recurrence and to evaluate the most correct subsequent therapeutic approach. In particular, for the group of patients with GIST at very-low and low risk of recurrence/progression, the evidences to support a specific follow-up program and its features are poor. On the basis of the aforementioned considerations, we propose a multi-institutional retrospective study in order to identify the most relevant and advisable features of follow-up, and to explore its impact on principal clinical outcomes. Moreover, a dedicated effort will be pursued to identify the peculiar characteristics (if any) of patients that experienced recurrence of the disease. The study will collect data about patients affected by primary GIST at very-low and low risk of recurrence/progression, referred to participating Institutions between January 2000 and February 2020
Study Type
OBSERVATIONAL
Enrollment
700
This observational study collects all the treatments received by the patients according clinical practices or experimental trials and therefore includes drug/biological/surgical and any other applicable treatments
Azienda Ospedaliero-Universitaria Di Bologna
Bologna, BO, Italy
Nuovo Ospedale di Prato
Prato, Firenze, Italy
Istituto Europeo di Oncologia
Milan, MI, Italy
To describe the most relevant features of follow-up in very-low and low risk GIST patients
Collection of retrospectively imaging characteristics
Time frame: Change from diagnosis (baseline)
To describe the most relevant features of follow-up in very-low and low risk GIST patients
Collection of retrospectively imaging characteristics.
Time frame: At 1 year
To describe the most relevant features of follow-up in very-low and low risk GIST patients
Collection of retrospectively imaging characteristics.
Time frame: At 2 years
To describe the most relevant features of follow-up in very-low and low risk GIST patients
Collection of retrospectively imaging characteristics.
Time frame: At 3 years
To describe the most relevant features of follow-up in very-low and low risk GIST patients
Collection of retrospectively imaging characteristics.
Time frame: At 5 years
To evaluate the onset of other neoplasms in very-low and low risk GIST patients
Onset of other neoplasm will be recoreded
Time frame: Chage from baseline (time of diagnosis) at 5 years
To assess baseline clinical and disease-specific factors with possible impact on survival analyses.
Collection of clinical symptoms, pathological and molecular characteristics at disease presentation/diagnosis
Time frame: Every 3 months (Month 3, Month 6, Month 9...) up to 5 years
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Istituto Clinico Humanitas
Rozzano, MI, Italy
Azienda Ospedaliera Universitaria Paolo Giaccone
Palermo, PA, Italy
Centro di Riferimento Oncologico - Unit of Medical Oncology
Aviano, Pordenone, Italy
Policlinico Universitario Campus Biomedico
Roma, RM, Italy
Fondazione del Piemonte per l'Oncologia IRCC Candiolo
Candiolo, Torino, Italy
Ospedale San Giovanni Bosco
Torino, TO, Italy
Policlinico S.Orsola Malpighi - Unit of Medical Oncology
Bologna, Italy
...and 3 more locations
Recurrence-free survival (RFS)
Time elapsed form the treatment (any) start and the onset of recurrence
Time frame: Every 3 months (Month 3, Month 6, Month 9...) up to 5 years
Post-recurrence progression-free survival (PR-PFS)
Time elapsed form the onset of 1st progression to a further progression
Time frame: Every 3 months (Month 3, Month 6, Month 9...) up to 5 years
Disease-Specific survival (DSS)
Time elapsed for the diagnosis to the death of disease
Time frame: at 5 years
Overall survival (OS).
Time elapsed for the diagnosis to the death for any cause
Time frame: at 5 years