CompletedNot Applicable

Study in Low Risk Gastrointestinal Stromal Tumor (GISTs)

Italy700 participantsStarted 2020-11-25

Plain-language summary

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

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * \>18 years at diagnosis * primary GIST removed by surgery or endoscopic procedures * availability of medical data needed for the study * very-low and low risk GIST defined as: * largest size of \< 3 cm (for all sites of origin) * gastric GIST with ≤ 5/50 High Power Fields (HPF) mitoses and ≤ 10 cm in the largest size * gastric GIST with \> 5/50 HPF mitoses and ≤ 5 cm in the largest size * intestinal GIST with ≤ 5/50 HPF mitoses and ≤ 5 cm in the largest size Exclusion Criteria: * Metastases at diagnosis. * Previous treatment with imatinib

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To describe the most relevant features of follow-up in very-low and low risk GIST patients

Timeframe: Change from diagnosis (baseline)

To describe the most relevant features of follow-up in very-low and low risk GIST patients

Timeframe: At 1 year

To describe the most relevant features of follow-up in very-low and low risk GIST patients

Timeframe: At 2 years

To describe the most relevant features of follow-up in very-low and low risk GIST patients

Timeframe: At 3 years

To describe the most relevant features of follow-up in very-low and low risk GIST patients

Timeframe: At 5 years

To evaluate the onset of other neoplasms in very-low and low risk GIST patients

Timeframe: Chage from baseline (time of diagnosis) at 5 years

Trial details

NCT IDNCT04599660

SponsorItalian Sarcoma Group

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2021-12-30

View on ClinicalTrials.gov More GIST trials

Plain-language summary

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

To describe the most relevant features of follow-up in very-low and low risk GIST patients

Timeframe: Change from diagnosis (baseline)

To describe the most relevant features of follow-up in very-low and low risk GIST patients

Timeframe: At 1 year

To describe the most relevant features of follow-up in very-low and low risk GIST patients

Timeframe: At 2 years

To describe the most relevant features of follow-up in very-low and low risk GIST patients

Timeframe: At 3 years

To describe the most relevant features of follow-up in very-low and low risk GIST patients

Timeframe: At 5 years

To evaluate the onset of other neoplasms in very-low and low risk GIST patients

Timeframe: Chage from baseline (time of diagnosis) at 5 years