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

Pilot study to evaluate the feasibility of an innovative approach to monitor patients with gastrointestinal stromal tumour treated with imatinib - Innovative approach to monitor GIST patients treated with imatinib

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002437-36-IT

Enrollment

Registered

2021-09-07

Start date

2017-12-05

Completion date

Unknown

Last updated

2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with gastrointestinal stromal tumour MedDRA version: 20.0 Level: LLT Classification code 10062427 Term: Gastrointestinal stromal tumor System Organ Class: 100000004864

Interventions

Trade Name: GLIVEC - 100 MG 120 CAPSULE RIGIDE USO ORALE Product Name: imatinib Product Code: [035372059] Pharmaceutical Form: Capsule, hard

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 2 YEARS;Main Objective: This pilot study primarily aims to verify the feasibility of practicing the combined approach on GIST patients treated with imatinib, evaluating: 1. The proportion of patients successfully monitored according to the protocol among the enrolled patients; 2. The time required for Cmin determination with conventional and new strategies for a simplified sample collection (DBS and microcapillary tubes); 3. The time required for giving the clinicians the results of the combined analysis (Cmin and ctDNA).;Secondary Objective: • To evaluate the possibility to early detect tumour progression through ctDNA analysis in patients’ plasma samples in course of treatment. • To verify the possible correlation between imatinib exposure and response (TTP), overall and by tumour mutational subtype; • To validate a point-of-care-testing (POCT) TDM (electrochemical biosensors and molecularly imprinted polymers); ;Primary end point(s): 1. Number of patients successfully monitored according to the protocol among the enrolled patients 2. The time required for TDM with conventional and new strategies for a simplified sample collection (DBS and microcapillary tubes) 3. The time required for giving the clinicians the results of the combined analysis (TDM and liquid biopsy)	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 2 YEARS;Main Objective: This pilot study primarily aims to verify the feasibility of practicing the combined approach on GIST patients treated with imatinib, evaluating: 1. The proportion of patients successfully monitored according to the protocol among the enrolled patients; 2. The time required for Cmin determination with conventional and new strategies for a simplified sample collection (DBS and microcapillary tubes); 3. The time required for giving the clinicians the results of the combined analysis (Cmin and ctDNA).;Secondary Objective: • To evaluate the possibility to early detect tumour progression through ctDNA analysis in patients’ plasma samples in course of treatment. • To verify the possible correlation between imatinib exposure and response (TTP), overall and by tumour mutational subtype; • To validate a point-of-care-testing (POCT) TDM (electrochemical biosensors and molecularly imprinted polymers); ;Primary end point(s): 1. Number of patients successfully monitored according to the protocol among the enrolled patients 2. The time required for TDM with conventional and new strategies for a simplified sample collection (DBS and microcapillary tubes) 3. The time required for giving the clinicians the results of the combined analysis (TDM and liquid biopsy)

—

Secondary

Measure	Time frame
Secondary end point(s): To evaluate the possibility to early detect tumour progression through ctDNA analysis in patients’ plasma samples in course of treatment; To verify the possible correlation between imatinib exposure and response (TTP), overall and by tumour mutational subtype; To validate a point-of-care-testing (POCT) TDM ;Timepoint(s) of evaluation of this end point: 2 years	—

Countries

Italy, Netherlands, United States

Contacts

Public ContactDirezione Scientifica

Centro di Riferimento Oncologico (CRO) IRCCS Aviano

dirscienti@cro.it0434 659282

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026