Patients With Locally Advanced Carcinoma of the Stomach and Oesophagogastric JunctionRADI-SNCT06044961
Radiomics-based Models for the Prediction of Pathological Response to Neoadjuvant Therapy in Gastric and Gastroesophageal Cancer
An observational study of Patients With Locally Advanced Carcinoma of the Stomach and Oesophagogastric Junction, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
Identifying predictors of response to neoadjuvant therapy in gastric and gastro-oesophageal cancer early in the history of the disease would ensure optimal treatment planning. The study aims to apply radiomics for the prediction of response to neoadjuvant therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patients With Locally Advanced Carcinoma of the Stomach and Oesophagogastric Junction
- What is being tested?
- CT scan
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2005to 15 Nov 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with locally advanced stomach cancer
Who may be able to join
- Patients with locally advanced stomach cancer undergoing neoadjuvant chemotherapy and gastrectomy between January 2005 and August 2022
Who cannot join
- Siewert 1 tumors;
- Patients who have received neoadjuvant with the addition of a biological drug;
- Patients who have received radiotherapy;
- Patients without staging CT scan or with insufficient image quality in terms of phases performed, pixel spacing, slide thickness (mandatorily: > 5 mm) or artefacts.
About this study
Identifying predictors of response to neoadjuvant therapy in gastric and gastro-oesophageal cancer early in the history of the disease would ensure optimal treatment planning.
The study aims to apply radiomics for the prediction of response to neoadjuvant therapy.
- Being tested
- CT scan
- Keywords
- stomach cancer, esophagogastric junction., locally advanced carcinoma of the stomach, radiomics
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanRadiation
All pre-operative CT scan collected
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of radiomics
Apply radiomics for predicting response to neoadjuvant therapy.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Jan 2005
- Primary completion30 Aug 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Locally Advanced Carcinoma of the Stomach and Oesophagogastric JunctionStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnes Annamaria, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044961
- Sponsor's protocol ID
- 5297
- Acronym
- RADI-S
- Status last verified
- Sep 2023
- First submitted
- 13 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiomics-based Models for the Prediction of Pathological Response to Neoadjuvant Therapy in Gastric and Gastroesophageal Cancer
- ClinicalTrials.gov ID
- NCT06044961
- Acronym / sponsor ID
- RADI-S / 5297
- Keywords
- stomach cancer, esophagogastric junction., locally advanced carcinoma of the stomach, radiomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jan 2005
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 21 Sep 2023 (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.
Identifying predictors of response to neoadjuvant therapy in gastric and gastro-oesophageal cancer early in the history of the disease would ensure optimal treatment planning.
The study aims to apply radiomics for the prediction of response to neoadjuvant therapy.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with locally advanced stomach cancer
Key inclusion criteria (1 listed)
- Patients with locally advanced stomach cancer undergoing neoadjuvant chemotherapy and gastrectomy between January 2005 and August 2022
Key exclusion criteria (4 listed)
- Siewert 1 tumors;
- Patients who have received neoadjuvant with the addition of a biological drug;
- Patients who have received radiotherapy;
- Patients without staging CT scan or with insufficient image quality in terms of phases performed, pixel spacing, slide thickness (mandatorily: > 5 mm) or artefacts.
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 |
|---|---|---|
| CT scanAll pre-operative CT scan collected | Radiation | – |
Primary outcome
Use of radiomics
Time frame: 1 month
Apply radiomics for predicting response to neoadjuvant therapy.
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 21 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Locally Advanced Carcinoma of the Stomach and Oesophagogastric Junction, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 4 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Use of radiomics (time frame: 1 month). 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 Sep 2023.