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Completed

NCT Number: NCT04599660

Study in Low Risk Gastrointestinal Stromal Tumor (GISTs)

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

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Key information

Conditions

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero-Universitaria Di Bologna, Bologna, BO, Italy

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment of Low Risk GISTs according clinical practice (includes drugs, surgery or any other received treatments)

Other

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

Primary outcomes

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

    Time frame: Change from diagnosis (baseline)

    Collection of retrospectively imaging characteristics

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

    Time frame: At 1 year

    Collection of retrospectively imaging characteristics.

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

    Time frame: At 2 years

    Collection of retrospectively imaging characteristics.

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

    Time frame: At 3 years

    Collection of retrospectively imaging characteristics.

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

    Time frame: At 5 years

    Collection of retrospectively imaging characteristics.

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

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

    Onset of other neoplasm will be recoreded

Secondary outcomes

  1. To assess baseline clinical and disease-specific factors with possible impact on survival analyses.

    Time frame: Every 3 months (Month 3, Month 6, Month 9...) up to 5 years

    Collection of clinical symptoms, pathological and molecular characteristics at disease presentation/diagnosis

  2. Recurrence-free survival (RFS)

    Time frame: Every 3 months (Month 3, Month 6, Month 9...) up to 5 years

    Time elapsed form the treatment (any) start and the onset of recurrence

  3. Post-recurrence progression-free survival (PR-PFS)

    Time frame: Every 3 months (Month 3, Month 6, Month 9...) up to 5 years

    Time elapsed form the onset of 1st progression to a further progression

  4. Disease-Specific survival (DSS)

    Time frame: at 5 years

    Time elapsed for the diagnosis to the death of disease

  5. Overall survival (OS).

    Time frame: at 5 years

    Time elapsed for the diagnosis to the death for any cause

Sponsors and collaborators

Lead sponsor

Italian Sarcoma Group

Network

Registry information

Official study title

Follow-up in Low Risk Gastrointestinal Stromal Tumors (GISTs) - Retrospective Analysis of Clinical Features and Outcomes

Acronym: RetroGIST

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Oct 23, 2020
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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