Subepithelial Gastrointestinal TumorsSunnyDay021NCT06324032
SUNNYDAY: SUbepithelialgastroiNtestiNal Tumors Detection,accuracYDiAgnosis,ElastographY and Contrast-enhanced EUS
An observational study of Subepithelial Gastrointestinal Tumors, run by Fondazione del Piemonte per l'Oncologia at 7 sites in Italy.
Trial summary
This will be a longitudinal, prospective, observational multicenter study where the role of EUS-E will be examined in differentiating subepithelial gastrointestinal tumors in 138 patients Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Subepithelial Gastrointestinal Tumors
- What is being tested?
- EUS Elastography (EUS-E)
- Type of treatment
- Surgery or procedure
- How many people
- 138 participants
- Where
- 7 sitesItaly
- Study dates
- 17 Dec 2020to 31 Dec 2025
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: for patients with all types of Gastro Intestinal SETs.
Who may be able to join
- 1. Patients with GI SETs scheduled for EUS-FNB 2 Patients with age > 18 but <85
Who cannot join
- Patients with GI SETs <15mm
- severe coagulopathy defined as abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma
- severe cardiopulmonary diseases and severe chronic kidney disease defined as
- known allergic disposition to SonoVue®
- pregnancy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites, 7 recruiting
- Recruiting
Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
Candiolo, Turin,, 10060
Teresa Staiano, MD, +390119933413, teresa.staiano@ircc.it
- Recruiting
Ospedale Humanitas Mater Domini
Castellanza, Varese
Benedetto Mangiavillano, MD
- Recruiting
Ospedale Santa Maria della Scaletta
Imola, Bologna
Pietro Fusaroli, MD
- Recruiting
AOU Maggiore della Carità
Novara, 28100
Pietro Occhipinti, MD
- Recruiting
Istituto Oncologico Veneto
Padova
Alberto Fantin, MD
- Recruiting
Istituto Clinico Humanitas
Rozzano, Milano
Silvia Carrara, MD
- Recruiting
AOU Città della Salute e della Scienza di Torino, Ospedale Molinette
Turin, 10126
Claudio G. De Angelis, MD
About this study
Official title: EUS-Elastography and Contrast-Enhanced EUS Diagnostic Accuracy in the Differential Diagnosis of Subepithelial Gastrointestinal Tumors: a Multicenter Prospective Observational Study
This will be a longitudinal, prospective, observational multicenter study where the role of EUS-E will be examined in differentiating subepithelial gastrointestinal tumors in 138 patients
Read the detailed description
This will be a longitudinal, prospective, observational multicenter study that will enroll consecutive patients, with gastrointestinal SETs diagnosed by experienced endoscopists at Italian hospitals. This study will be conducted following the Helsinki Declaration after the approval by the ethics review board of all centers and will be recorded on Clinical-Trials.gov. All patients will provide their written informed consent for participating in the study. The EUS-E and CEUS analysis with SonoVue® will be performed during the same procedures. A subsequent diagnostic hypothesis on the nature of SETs will be formulated based on the B-mode, EUS-E, and CE-EUS characteristics.
- Conditions
- Subepithelial Gastrointestinal Tumors
- Being tested
- EUS Elastography (EUS-E)
- Keywords
- subepithelial gastrointestinal tumors, Endoscopic Ultrasound, EUS, SETs, EUS Elastography, surgical resection, histopatological specimens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS Elastography (EUS-E)Procedure or surgery
Also called Endoscopic Ultrasound (EUS), Contrast Enhanced-EUS (CE-EUS)
All procedures will be performed with Olympus echoendoscopes (Olympus Europa SE \& CO. KG, Hamburg, Germany) or Pentax echoendoscopes in combination with dedicated elastography software
| Study group | Role | What they receive |
|---|---|---|
| Patients with subepithelial gastrointestinal tumors | Patients with subepithelial gastrointestinal tumors Receives: Procedure: EUS Elastography (EUS-E) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of EUS-E accuracy qualitative
Evaluation of Endoscopic Ultrasound -Elastography (EUS-E)) accuracy (qualitative elastography) and contrast enhanced endoscopic ultrasound (CE-EUS) in the diagnosis of SETs compared to the histological data provided by the ultrasound-guided biopsy.
the elastographic qualitative pattern will be assessed and described using an elastographic score.
ELASTOGRAPHIC SCORE: three elastographic patterns will be used to define the stiffness of the SETs:
- homogeneously green-pattern (soft)
- mixed-type pattern (mild stiffness)
- blue-predominant elastographic pattern (hard) Strain Ratio (SR) will be calculated by dividing the ROI placed on the normal GI wall at the periphery of the mass (ROI B) by the ROI placed on the lesion itself (ROI A). ROI A will be manually adjusted to cover the tumoral area as much as possible.
Measured: 4 weeks
Evaluation of EUS-E accuracy quantitative
Evaluation of Endoscopic Ultrasound -Elastography (EUS-E) accuracy (quantitative elastography) and contrast enhanced endoscopic ultrasound (CE-EUS) in the diagnosis of SETs compared to the histological data provided by the ultrasound-guided biopsy.
EUS-E compares the strain between the target area and other reference areas, to provide a semi-quantitative analysis of tissue stiffness.
The SR (B/A quotients) will be calculated by the diagnostic US imaging system. The SRs will be measured and recorded 3 times in each procedure; the mean value will be considered as the final result for data analysis(to establish an SR cut-off to differentiate GIST from other SETs). Videos of 5 seconds will be recorded per each measurement.
Measured: 4 weeks
Secondary outcomes (4)
Evaluation of diagnostic accuracy of EUS-biopsy with fine needle biopsy (FNB)
Evaluation of diagnostic accuracy of Endoscopic Ultrasound biopsy (EUS-biopsy) with fine needle biopsy (FNB).
Is obtained by evaluating the Strain Ratio (SR). Strain Ratio (SR) is a value resulting from the ratio between the stiffness of two user-defined areas within an elastogram ,which provides an objective evaluation of the hardness of lesion. Therefore, EUS-E has been applied to diseases of the pancreas, liver, prostate, lymphnodes, and other SETs
Measured: 4 weeks
Evaluation of gene mutations in EUS-guided specimen
Evaluation of genetic mutations in ultrasound-guided endoscopic specimens by analyzing the tissue.
All specimens will undergo histopathological examination, immunohistochemical evaluation, and molecular analysis
Measured: 24 weeks
Correlation of elastographic and contrastographic characteristics of SETs with the pathological risk stratification.
Correlation of elastographic and contrastographic characteristics of SubEpithelial Tumors (SETs) with the pathological risk stratification.
The elasticity of the tissues will be evaluated, which presents itself as a chromatic spectrum of shades and expressed graphically in an elastogram. The green color represents medium stiffness, blue reflects the hardest tissue and red the softest tissue.
Measured: 24 weeks
Complication rate (perforations, bleeding) of the procedure
Complication rate (perforations, bleeding) of the procedure will be obtained by evaluating the number of complications
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start17 Dec 2020
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subepithelial Gastrointestinal TumorsStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teresa Staiano, MD, Principal investigator, FPO-IRCCS di Candiolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324032
- Sponsor's protocol ID
- 021-FPO20
- Acronym
- SunnyDay021
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: contact the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS-Elastography and Contrast-Enhanced EUS Diagnostic Accuracy in the Differential Diagnosis of Subepithelial Gastrointestinal Tumors: a Multicenter Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06324032
- Acronym / sponsor ID
- SunnyDay021 / 021-FPO20
- Conditions
- Subepithelial Gastrointestinal Tumors
- Keywords
- subepithelial gastrointestinal tumors, Endoscopic Ultrasound, EUS, SETs, EUS Elastography, surgical resection, histopatological specimens
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Fondazione del Piemonte per l'OncologiaUniversity, hospital or other
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Mar 2024 (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 will be a longitudinal, prospective, observational multicenter study where the role of EUS-E will be examined in differentiating subepithelial gastrointestinal tumors in 138 patients
Detailed description
This will be a longitudinal, prospective, observational multicenter study that will enroll consecutive patients, with gastrointestinal SETs diagnosed by experienced endoscopists at Italian hospitals. This study will be conducted following the Helsinki Declaration after the approval by the ethics review board of all centers and will be recorded on Clinical-Trials.gov. All patients will provide their written informed consent for participating in the study. The EUS-E and CEUS analysis with SonoVue® will be performed during the same procedures. A subsequent diagnostic hypothesis on the nature of SETs will be formulated based on the B-mode, EUS-E, and CE-EUS characteristics.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with subepithelial gastrointestinal tumors | – | Procedure: EUS Elastography (EUS-E)Patients with subepithelial gastrointestinal tumors |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- for patients with all types of Gastro Intestinal SETs.
Key inclusion criteria (1 listed)
- 1. Patients with GI SETs scheduled for EUS-FNB 2 Patients with age > 18 but <85
Key exclusion criteria (5 listed)
- Patients with GI SETs <15mm
- severe coagulopathy defined as abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma
- severe cardiopulmonary diseases and severe chronic kidney disease defined as
- known allergic disposition to SonoVue®
- pregnancy
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 |
|---|---|---|
| EUS Elastography (EUS-E)Also: Endoscopic Ultrasound (EUS), Contrast Enhanced-EUS (CE-EUS)All procedures will be performed with Olympus echoendoscopes (Olympus Europa SE \& CO. KG, Hamburg, Germany) or Pentax echoendoscopes in combination with dedicated elastography software | Procedure or surgery | Patients with subepithelial gastrointestinal tumors |
Primary outcome
Evaluation of EUS-E accuracy qualitative
Time frame: 4 weeks
Evaluation of Endoscopic Ultrasound -Elastography (EUS-E)) accuracy (qualitative elastography) and contrast enhanced endoscopic ultrasound (CE-EUS) in the diagnosis of SETs compared to the histological data provided by the ultrasound-guided biopsy. the elastographic qualitative pattern will be assessed and described using an elastographic score. ELASTOGRAPHIC SCORE: three elastographic patterns will be used to define the stiffness of the SETs: * homogeneously green-pattern (soft) * mixed-type pattern (mild stiffness) * blue-predominant elastographic pattern (hard) Strain Ratio (SR) will be calculated by dividing the ROI placed on the normal GI wall at the periphery of the mass (ROI B) by the ROI placed on the lesion itself (ROI A). ROI A will be manually adjusted to cover the tumoral area as much as possible.
Evaluation of EUS-E accuracy quantitative
Time frame: 4 weeks
Evaluation of Endoscopic Ultrasound -Elastography (EUS-E) accuracy (quantitative elastography) and contrast enhanced endoscopic ultrasound (CE-EUS) in the diagnosis of SETs compared to the histological data provided by the ultrasound-guided biopsy. EUS-E compares the strain between the target area and other reference areas, to provide a semi-quantitative analysis of tissue stiffness. The SR (B/A quotients) will be calculated by the diagnostic US imaging system. The SRs will be measured and recorded 3 times in each procedure; the mean value will be considered as the final result for data analysis(to establish an SR cut-off to differentiate GIST from other SETs). Videos of 5 seconds will be recorded per each measurement.
4 secondary outcomes
Evaluation of diagnostic accuracy of EUS-biopsy with fine needle biopsy (FNB)
Time frame: 4 weeks
Evaluation of gene mutations in EUS-guided specimen
Time frame: 24 weeks
Correlation of elastographic and contrastographic characteristics of SETs with the pathological risk stratification.
Time frame: 24 weeks
Complication rate (perforations, bleeding) of the procedure
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: No. contact the principal investigator
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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.
Teresa Staiano, MD principal investigator
FPO-IRCCS di Candiolo
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subepithelial Gastrointestinal Tumors, run by Fondazione del Piemonte per l'Oncologia at 7 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristiana Laudi, MD (+390119933413, Cristiana.laudi@ircc.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of EUS-E accuracy qualitative (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2024.