Study for an innovative approach for the monitoring of patients with gastrointestinal stromal tumour treated with imatinib

Phase 1

• Conditions: Patients with gastrointestinal stromal tumour; MedDRA version: 20.0Level: LLTClassification code 10062427Term: Gastrointestinal stromal tumorSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2017-002437-36-IT
• Lead Sponsor: CENTRO DI RIFERIMENTO ONCOLOGICO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-07
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Histologically or cytologically confirmed diagnosis of metastatic GIST eligible for imatinib treatment according to the routine clinical practice criteria; Age =18; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with adequate liver, renal and bone marrow functions; Life expectancy > 3 months; Just for patients already on-treatment with imatinib, the therapy must be initiated more than 3 months prior to the first sample collection (to reach a stable blood drug concentration); Signed informed consent and local Ethical Committee (EC) approval availability; All patients in fertile age must have been under contraceptive treatment;
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

Pregnancy status; Refusal of informed consent; non-collaborative and/or unreliable patients; Patients who could not attend periodic clinical check-ups.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified