GISTRetroGISTNCT04599660
Study in Low Risk Gastrointestinal Stromal Tumor (GISTs)
An observational study of GIST, run by Italian Sarcoma Group at 13 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- GIST
- What is being tested?
- Treatment of Low Risk GISTs according clinical practice (includes drugs, surgery or any other received treatments)
- How many people
- 700 participants
- Where
- 13 sitesItaly
- Study dates
- 25 Nov 2020to 20 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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 may be able to join
- >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
Who cannot join
- Metastases at diagnosis.
- Previous treatment with imatinib
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Italy13 sites
Centro di Riferimento Oncologico - Unit of Medical Oncology
Aviano, Pordenone, 33081
Azienda Ospedaliero-Universitaria Di Bologna
Bologna, BO, 40139
Policlinico S.Orsola Malpighi - Unit of Medical Oncology
Bologna, 40138
Fondazione del Piemonte per l'Oncologia IRCC Candiolo
Candiolo, Torino, 10060
Azienda Ospedaliera Universitaria Careggi
Florence, 50100
Istituto Europeo di Oncologia
Milan, MI, 20141
Fondazione IRCCS INT Milano
Milan, 20133
Azienda Ospedaliera Universitaria Paolo Giaccone
Palermo, PA, 90127
Nuovo Ospedale di Prato
Prato, Firenze, 59100
Policlinico Universitario Campus Biomedico
Roma, RM, 00128
Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I
Roma, 00144
Istituto Clinico Humanitas
Rozzano, MI, 20089
Ospedale San Giovanni Bosco
Torino, TO
About this study
Official title: Follow-up in Low Risk Gastrointestinal Stromal Tumors (GISTs) - Retrospective Analysis of Clinical Features and Outcomes
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
Read the detailed description
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
- Conditions
- GIST
- Being tested
- Treatment of Low Risk GISTs according clinical practice (includes drugs, surgery or any other received treatments)
- Keywords
- GIST, Gastro Intestinal Stromal Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Low Risk GISTs | This cohort include patients affected by primary GIST at very-low and low risk of recurrence/progression, referred to participating Institutions between January 2000 and February 2020. Receives: Other: Treatment of Low Risk GISTs according clinical practice (includes drugs, surgery or any other received treatments) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the most relevant features of follow-up in very-low and low risk GIST patients
Collection of retrospectively imaging characteristics
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Chage from baseline (time of diagnosis) at 5 years
Secondary outcomes (5)
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
Measured: Every 3 months (Month 3, Month 6, Month 9...) up to 5 years
Recurrence-free survival (RFS)
Time elapsed form the treatment (any) start and the onset of recurrence
Measured: 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
Measured: 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
Measured: at 5 years
Overall survival (OS).
Time elapsed for the diagnosis to the death for any cause
Measured: at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start25 Nov 2020
- Primary completion30 Dec 2021
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for GISTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Italian Sarcoma Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Giovanni Grignani, Study chair, giovanni.grignani@ircc.it
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599660
- Sponsor's protocol ID
- ISG-RetroGIST LR
- Acronym
- RetroGIST
- Status last verified
- Dec 2023
- First submitted
- 15 Oct 2020
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Joensuu H, Hohenberger P, Corless CL. Gastrointestinal stromal tumour. Lancet. 2013 Sep 14;382(9896):973-83. doi: 10.1016/S0140-6736(13)60106-3. Epub 2013 Apr 24.
PubMed 23623056Gold JS, Gonen M, Gutierrez A, Broto JM, Garcia-del-Muro X, Smyrk TC, Maki RG, Singer S, Brennan MF, Antonescu CR, Donohue JH, DeMatteo RP. Development and validation of a prognostic nomogram for recurrence-free survival after complete surgical resection of localised primary gastrointestinal stromal tumour: a retrospective analysis. Lancet Oncol. 2009 Nov;10(11):1045-52. doi: 10.1016/S1470-2045(09)70242-6. Epub 2009 Sep 28.
PubMed 19793678D'Ambrosio L, Palesandro E, Boccone P, Tolomeo F, Miano S, Galizia D, Manca A, Chiara G, Bertotto I, Russo F, Campanella D, Venesio T, Sangiolo D, Pignochino Y, Siatis D, De Simone M, Ferrero A, Pisacane A, Dei Tos AP, Aliberti S, Aglietta M, Grignani G. Impact of a risk-based follow-up in patients affected by gastrointestinal stromal tumour. Eur J Cancer. 2017 Jun;78:122-132. doi: 10.1016/j.ejca.2017.03.025. Epub 2017 Apr 24.
PubMed 28448856Joensuu H, Reichardt P, Eriksson M, Sundby Hall K, Vehtari A. Gastrointestinal stromal tumor: a method for optimizing the timing of CT scans in the follow-up of cancer patients. Radiology. 2014 Apr;271(1):96-103. doi: 10.1148/radiol.13131040. Epub 2013 Nov 18.
PubMed 24475826Rossi S, Miceli R, Messerini L, Bearzi I, Mazzoleni G, Capella C, Arrigoni G, Sonzogni A, Sidoni A, Toffolatti L, Laurino L, Mariani L, Vinaccia V, Gnocchi C, Gronchi A, Casali PG, Dei Tos AP. Natural history of imatinib-naive GISTs: a retrospective analysis of 929 cases with long-term follow-up and development of a survival nomogram based on mitotic index and size as continuous variables. Am J Surg Pathol. 2011 Nov;35(11):1646-56. doi: 10.1097/PAS.0b013e31822d63a7.
PubMed 21997685Casali PG, Abecassis N, Aro HT, Bauer S, Biagini R, Bielack S, Bonvalot S, Boukovinas I, Bovee JVMG, Brodowicz T, Broto JM, Buonadonna A, De Alava E, Dei Tos AP, Del Muro XG, Dileo P, Eriksson M, Fedenko A, Ferraresi V, Ferrari A, Ferrari S, Frezza AM, Gasperoni S, Gelderblom H, Gil T, Grignani G, Gronchi A, Haas RL, Hassan B, Hohenberger P, Issels R, Joensuu H, Jones RL, Judson I, Jutte P, Kaal S, Kasper B, Kopeckova K, Krakorova DA, Le Cesne A, Lugowska I, Merimsky O, Montemurro M, Pantaleo MA, Piana R, Picci P, Piperno-Neumann S, Pousa AL, Reichardt P, Robinson MH, Rutkowski P, Safwat AA, Schoffski P, Sleijfer S, Stacchiotti S, Sundby Hall K, Unk M, Van Coevorden F, van der Graaf WTA, Whelan J, Wardelmann E, Zaikova O, Blay JY; ESMO Guidelines Committee and EURACAN. Gastrointestinal stromal tumours: ESMO-EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018 Oct 1;29(Suppl 4):iv267. doi: 10.1093/annonc/mdy320. No abstract available.
PubMed 30188977
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up in Low Risk Gastrointestinal Stromal Tumors (GISTs) - Retrospective Analysis of Clinical Features and Outcomes
- ClinicalTrials.gov ID
- NCT04599660
- Acronym / sponsor ID
- RetroGIST / ISG-RetroGIST LR
- Conditions
- GIST
- Keywords
- GIST, Gastro Intestinal Stromal Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Italian Sarcoma GroupResearch network
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low Risk GISTs | – | Other: Treatment of Low Risk GISTs according clinical practice (includes drugs, surgery or any other received treatments)This cohort include 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 may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients affected by primary GIST at very-low and low risk of recurrence/progression, referred to participating Institutions between January 2000 and February 2020.
Key inclusion criteria (8 listed)
- >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:
Key exclusion criteria (2 listed)
- Metastases at diagnosis.
- Previous treatment with imatinib
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment of Low Risk GISTs according clinical practice (includes drugs, surgery or any other received treatments)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 | Other | Low Risk GISTs |
Primary outcome
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
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.
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.
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.
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.
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
5 secondary outcomes
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
Recurrence-free survival (RFS)
Time frame: Every 3 months (Month 3, Month 6, Month 9...) up to 5 years
Post-recurrence progression-free survival (PR-PFS)
Time frame: Every 3 months (Month 3, Month 6, Month 9...) up to 5 years
Disease-Specific survival (DSS)
Time frame: at 5 years
Overall survival (OS).
Time frame: at 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Background: PubMed 23623056Joensuu H, Hohenberger P, Corless CL. Gastrointestinal stromal tumour. Lancet. 2013 Sep 14;382(9896):973-83. doi: 10.1016/S0140-6736(13)60106-3. Epub 2013 Apr 24.
- Background: PubMed 19793678Gold JS, Gonen M, Gutierrez A, Broto JM, Garcia-del-Muro X, Smyrk TC, Maki RG, Singer S, Brennan MF, Antonescu CR, Donohue JH, DeMatteo RP. Development and validation of a prognostic nomogram for recurrence-free survival after complete surgical resection of localised primary gastrointestinal stromal tumour: a retrospective analysis. Lancet Oncol. 2009 Nov;10(11):1045-52. doi: 10.1016/S1470-2045(09)70242-6. Epub 2009 Sep 28.
- Background: PubMed 28448856D'Ambrosio L, Palesandro E, Boccone P, Tolomeo F, Miano S, Galizia D, Manca A, Chiara G, Bertotto I, Russo F, Campanella D, Venesio T, Sangiolo D, Pignochino Y, Siatis D, De Simone M, Ferrero A, Pisacane A, Dei Tos AP, Aliberti S, Aglietta M, Grignani G. Impact of a risk-based follow-up in patients affected by gastrointestinal stromal tumour. Eur J Cancer. 2017 Jun;78:122-132. doi: 10.1016/j.ejca.2017.03.025. Epub 2017 Apr 24.
- Background: PubMed 24475826Joensuu H, Reichardt P, Eriksson M, Sundby Hall K, Vehtari A. Gastrointestinal stromal tumor: a method for optimizing the timing of CT scans in the follow-up of cancer patients. Radiology. 2014 Apr;271(1):96-103. doi: 10.1148/radiol.13131040. Epub 2013 Nov 18.
- Background: PubMed 21997685Rossi S, Miceli R, Messerini L, Bearzi I, Mazzoleni G, Capella C, Arrigoni G, Sonzogni A, Sidoni A, Toffolatti L, Laurino L, Mariani L, Vinaccia V, Gnocchi C, Gronchi A, Casali PG, Dei Tos AP. Natural history of imatinib-naive GISTs: a retrospective analysis of 929 cases with long-term follow-up and development of a survival nomogram based on mitotic index and size as continuous variables. Am J Surg Pathol. 2011 Nov;35(11):1646-56. doi: 10.1097/PAS.0b013e31822d63a7.
- Background: PubMed 30188977Casali PG, Abecassis N, Aro HT, Bauer S, Biagini R, Bielack S, Bonvalot S, Boukovinas I, Bovee JVMG, Brodowicz T, Broto JM, Buonadonna A, De Alava E, Dei Tos AP, Del Muro XG, Dileo P, Eriksson M, Fedenko A, Ferraresi V, Ferrari A, Ferrari S, Frezza AM, Gasperoni S, Gelderblom H, Gil T, Grignani G, Gronchi A, Haas RL, Hassan B, Hohenberger P, Issels R, Joensuu H, Jones RL, Judson I, Jutte P, Kaal S, Kasper B, Kopeckova K, Krakorova DA, Le Cesne A, Lugowska I, Merimsky O, Montemurro M, Pantaleo MA, Piana R, Picci P, Piperno-Neumann S, Pousa AL, Reichardt P, Robinson MH, Rutkowski P, Safwat AA, Schoffski P, Sleijfer S, Stacchiotti S, Sundby Hall K, Unk M, Van Coevorden F, van der Graaf WTA, Whelan J, Wardelmann E, Zaikova O, Blay JY; ESMO Guidelines Committee and EURACAN. Gastrointestinal stromal tumours: ESMO-EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018 Oct 1;29(Suppl 4):iv267. doi: 10.1093/annonc/mdy320. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Grignani study chair
giovanni.grignani@ircc.it
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GIST, run by Italian Sarcoma Group at 13 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe the most relevant features of follow-up in very-low and low risk GIST patients (time frame: Change from diagnosis (baseline)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04599660, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.