Gastric CancerNCT05465512
Using Radiomics to Predict Neoadjuvant Chemotherapy Efficacy
An observational study of Gastric Cancer, run by Fujian Medical University at 1 site in China.
Trial summary
Neoadjuvant chemotherapy (NC) is an important treatment for advanced gastric cancer (AGC). However, tools that effectively predict the efficacy of NC before treatment are lacking. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- response to neoadjuvant chemotherapy
- How many people
- 193 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2022to 10 Jul 2022
- How long will I take part?
- 3 Years
- 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
- Adult, Older adult
Study population: Prospective collection and a retrospective analysis of patients seen from January 2010 to December 2018 at Fujian Medical University Union Hospital (FMUUH) and the First Hospital of Lanzhou University (FHLU) who were diagnosed with gastric adenocarcinoma and underwent radical resection yielded 193 neoadjuvant chemotherapy (NC) patients, including 148 cases from FMUUH (derivation cohort) and 45 cases from the FHLU (validation cohort). Of the 148 patients from FMUUH, 139 had computed tomography (CT) images before NC, 141 had CT images after NC, and 132 had CT images before and after NC. All 45 patients in the FHLU underwent CT before and after NC. Patients with concurrent malignant disease, distant metastases, palliative resection, or gastric stump cancer were excluded.
Who may be able to join
- Prospective collection and a retrospective analysis of patients seen from January 2010 to December 2018 at Fujian Medical University Union Hospital (FMUUH) and the First Hospital of Lanzhou University (FHLU) who were diagnosed with gastric adenocarcinoma and underwent radical resection
Who cannot join
- Patients with concurrent malignant disease, distant metastases, palliative resection, or gastric stump cancer were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Radiomics to Predict Neoadjuvant Chemotherapy Efficacy and Postoperative Adjuvant Chemotherapy Benefit in Advanced Gastric Cancer: a Two-center Study
Neoadjuvant chemotherapy (NC) is an important treatment for advanced gastric cancer (AGC). However, tools that effectively predict the efficacy of NC before treatment are lacking. Computed tomography images before and after NC were used to construct a deep learning-based radiomics signature to predict the efficacy of NC, prognoses and postoperative adjuvant chemotherapy benefit.
Read the detailed description
Background: Neoadjuvant chemotherapy (NC) is an important treatment for advanced gastric cancer (AGC). However, tools that effectively predict the efficacy of NC before treatment are lacking.
Methods: Computed tomography images before and after NC were used to construct a deep learning-based radiomics signature to predict the efficacy of NC, prognoses and postoperative adjuvant chemotherapy benefit. Tumor regression grade (TRG) =0 or 1 was defined as a good response to neoadjuvant chemotherapy (GRNC), and TRG=2 or 3 was defined as a poor response to neoadjuvant chemotherapy (PRNC). 193 patients with AGC from January 2010 to December 2018 in two different China university hospitals were included in this study. The before neoadjuvant chemotherapy imaging scoring system (BNCISS), imaging change scoring system before and after neoadjuvant chemotherapy (ICSS), which were constructed based on computed tomography images before after treatment.
- Conditions
- Gastric Cancer
- Being tested
- response to neoadjuvant chemotherapy
- Keywords
- tumor regression grade, radiomics, neoadjuvant chemotherapy, advanced gastric cancer, chemotherapy benefit
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
response to neoadjuvant chemotherapyOther
Tumor regression grade (TRG) =0 or 1 was defined as a good response to neoadjuvant chemotherapy (GRNC), and TRG=2 or 3 was defined as a poor response to neoadjuvant chemotherapy (PRNC).
| Study group | Role | What they receive |
|---|---|---|
| good response to neoadjuvant chemotherapy (GRNC) | Tumor regression grade (TRG) =0 or 1 was defined as a good response to neoadjuvant chemotherapy (GRNC) Receives: Other: response to neoadjuvant chemotherapy | |
| poor response to neoadjuvant chemotherapy (PRNC) | TRG=2 or 3 was defined as a poor response to neoadjuvant chemotherapy (PRNC). Receives: Other: response to neoadjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC for ICSS
The predictive performance of imaging change scoring system before and after neoadjuvant chemotherapy (ICSS)
Measured: 2022-01-01 to 2022-07-31
AUC for BNCISS
The predictive performance of before neoadjuvant chemotherapy imaging scoring system (BNCISS)
Measured: 2022-01-01 to 2022-07-31
Secondary outcomes (2)
overall survival
3 year overall survival
Measured: 2010-01-01 to 2022-07-31
disease free survival
3 year disease free survival
Measured: 2010-01-01 to 2022-07-31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start4 Jan 2022
- Primary completion1 Jun 2022
- Study completion10 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 193 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Ming Huang, Prof., Fujian Medical University
- Investigators
- Hualong Zheng, Study director, 291167038@qq.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465512
- Sponsor's protocol ID
- FMUUH-001
- Status last verified
- Jul 2022
- First submitted
- 12 Jul 2022
- Last updated
- 19 Jul 2022
- 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 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Radiomics to Predict Neoadjuvant Chemotherapy Efficacy and Postoperative Adjuvant Chemotherapy Benefit in Advanced Gastric Cancer: a Two-center Study
- ClinicalTrials.gov ID
- NCT05465512
- Acronym / sponsor ID
- FMUUH-001
- Conditions
- Gastric Cancer
- Keywords
- tumor regression grade, radiomics, neoadjuvant chemotherapy, advanced gastric cancer, chemotherapy benefit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 19 Jul 2022 (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.
Neoadjuvant chemotherapy (NC) is an important treatment for advanced gastric cancer (AGC). However, tools that effectively predict the efficacy of NC before treatment are lacking. Computed tomography images before and after NC were used to construct a deep learning-based radiomics signature to predict the efficacy of NC, prognoses and postoperative adjuvant chemotherapy benefit.
Detailed description
Background: Neoadjuvant chemotherapy (NC) is an important treatment for advanced gastric cancer (AGC). However, tools that effectively predict the efficacy of NC before treatment are lacking.
Methods: Computed tomography images before and after NC were used to construct a deep learning-based radiomics signature to predict the efficacy of NC, prognoses and postoperative adjuvant chemotherapy benefit. Tumor regression grade (TRG) =0 or 1 was defined as a good response to neoadjuvant chemotherapy (GRNC), and TRG=2 or 3 was defined as a poor response to neoadjuvant chemotherapy (PRNC). 193 patients with AGC from January 2010 to December 2018 in two different China university hospitals were included in this study. The before neoadjuvant chemotherapy imaging scoring system (BNCISS), imaging change scoring system before and after neoadjuvant chemotherapy (ICSS), which were constructed based on computed tomography images before after treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| good response to neoadjuvant chemotherapy (GRNC) | – | Other: response to neoadjuvant chemotherapyTumor regression grade (TRG) =0 or 1 was defined as a good response to neoadjuvant chemotherapy (GRNC) |
| poor response to neoadjuvant chemotherapy (PRNC) | – | Other: response to neoadjuvant chemotherapyTRG=2 or 3 was defined as a poor response to neoadjuvant chemotherapy (PRNC). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Prospective collection and a retrospective analysis of patients seen from January 2010 to December 2018 at Fujian Medical University Union Hospital (FMUUH) and the First Hospital of Lanzhou University (FHLU) who were diagnosed with gastric adenocarcinoma and underwent radical resection yielded 193 neoadjuvant chemotherapy (NC) patients, including 148 cases from FMUUH (derivation cohort) and 45 cases from the FHLU (validation cohort). Of the 148 patients from FMUUH, 139 had computed tomography (CT) images before NC, 141 had CT images after NC, and 132 had CT images before and after NC. All 45 patients in the FHLU underwent CT before and after NC. Patients with concurrent malignant disease, distant metastases, palliative resection, or gastric stump cancer were excluded.
Key inclusion criteria (1 listed)
- Prospective collection and a retrospective analysis of patients seen from January 2010 to December 2018 at Fujian Medical University Union Hospital (FMUUH) and the First Hospital of Lanzhou University (FHLU) who were diagnosed with gastric adenocarcinoma and underwent radical resection
Key exclusion criteria (1 listed)
- Patients with concurrent malignant disease, distant metastases, palliative resection, or gastric stump cancer were excluded.
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 |
|---|---|---|
| response to neoadjuvant chemotherapyTumor regression grade (TRG) =0 or 1 was defined as a good response to neoadjuvant chemotherapy (GRNC), and TRG=2 or 3 was defined as a poor response to neoadjuvant chemotherapy (PRNC). | Other | good response to neoadjuvant chemotherapy (GRNC), poor response to neoadjuvant chemotherapy (PRNC) |
Primary outcome
AUC for ICSS
Time frame: 2022-01-01 to 2022-07-31
The predictive performance of imaging change scoring system before and after neoadjuvant chemotherapy (ICSS)
AUC for BNCISS
Time frame: 2022-01-01 to 2022-07-31
The predictive performance of before neoadjuvant chemotherapy imaging scoring system (BNCISS)
2 secondary outcomes
overall survival
Time frame: 2010-01-01 to 2022-07-31
disease free survival
Time frame: 2010-01-01 to 2022-07-31
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 19 Jul 2022.
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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.
Hualong Zheng study director
291167038@qq.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Fujian Medical University at 1 site in China.
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 1 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 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
AUC for ICSS (time frame: 2022-01-01 to 2022-07-31). 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 19 Jul 2022.