Gastric CancerNCT05722275
Prediction of Peritoneal Metastasis for Gastric Cancer Based on Radiomics
An observational study of Gastric Cancer and Peritoneal Metastases, run by Chinese Academy of Sciences at 13 sites in 2 countries.
Trial summary
Peritoneal metastasis of gastric cancer is difficult to be detected in time, thus delaying treatment. Based on the conventional CT images of gastric cancer, this study plans to develop, improve and validate an intelligent analysis system based on radiomics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Peritoneal Metastases
- What is being tested?
- Peritoneal metastasis status ascertainment
- How many people
- 400 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 1 Jan 2023to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All included patients are initially diagnosed as peritoneal metastasis-negative by CT, but later confirmed with the actual peritoneal metastasis status in laparoscopic exploration.
Who may be able to join
- (1) diagnosed advanced gastric cancer (≥cT3) by endoscopy-biopsy pathology, combined with CT and/or endoscopic ultrasound;
- (2) with both enhanced CT and laparoscopy;
- (3) without typical peritoneal metastasis indications in CT (diffuse omental nodules or omental cake, large amount of ascites, obvious irregular thickening with high peritoneal enhancement);
- (4) without other evidence of distant metastasis, and no stage IV features on CT.
Who cannot join
- (1) previous abdominal surgery;
- (2) previous abdominal malignancies or inflammatory diseases;
- (3) time intervals between CT and laparoscopy longer than 2 weeks;
- (4) CT image artifacts that undermine peritoneal lesion assessment.
Trial locations and contacts
13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Yali Zang, Ph.D contact
13 sites in 2 countries
China12 sites, 12 recruiting
- Recruiting
Peking University Cancer Hospital & Institute
Beijing
Lei Tang
- Recruiting
Fujian Medical University Union Hospital
Fuzhou
Changming Huang, MD
- Recruiting
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou
Shuzhong Cui, MD
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou
Zaiyi Liu, MD
- Recruiting
Nanfang Hospital of Southern Medical University
Guangzhou
Guoxin Li
- Recruiting
Sun Yat-Sen University Cancer Hospital
Guangzhou
Linquan Tang, MD
- Recruiting
Guizhou Provincial People's Hospital
Guiyang
Rongping Wang
- Recruiting
Yunnan Cancer Hospital
Kunming
Zhenhui Li, MD
- Recruiting
Shanxi Province Cancer Hospital
Taiyuan
Yanfen Cui, MD
- Recruiting
Henan Cancer Hospital
Zhengzhou
Jing Li
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Jianbo Gao
- Recruiting
Zhenjiang First People's Hospital
Zhenjiang
Xiuhong Shan
Italy1 site, 1 recruiting
- Recruiting
Scientific Institute San Raffaele
Milan
Francesco De Cobelli
About this study
Official title: Prediction of Peritoneal Metastasis for Gastric Cancer Based on Radiomics: a Multi-center Prospective Study
Peritoneal metastasis of gastric cancer is difficult to be detected in time, thus delaying treatment. Based on the conventional CT images of gastric cancer, this study plans to develop, improve and validate an intelligent analysis system based on radiomics. By extracting and combining the radiomics features related to peritoneal metastasis of gastric cancer, the intelligent analysis system could predict the risk of peritoneal metastasis, and provide personalized decision suggestions for the treatment of gastric cancer.
Read the detailed description
Peritoneal metastasis of gastric cancer is difficult to be detected in time, thus delaying treatment. Based on the conventional CT images of gastric cancer, this study plans to develop, improve and validate an intelligent analysis system based on radiomics. By extracting and combining the radiomics features related to peritoneal metastasis of gastric cancer, the intelligent analysis system could predict the risk of peritoneal metastasis, and provide personalized decision suggestions for the treatment of gastric cancer.
- Conditions
- Gastric Cancer, Peritoneal Metastases
- Being tested
- Peritoneal metastasis status ascertainment
- Keywords
- Artificial Intelligence, Classification, Gastric Cancer, Peritoneal Metastases, Computed Tomography, 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.
Peritoneal metastasis status ascertainmentDiagnostic test
Each participant with gastric cancer will undergo enhanced CT examination for detection of peritoneal metastasis. Within two weeks of CT examination, the participant will undergo diagnostic laparoscopy to confirm the status of peritoneal metastasis.
| Study group | Role | What they receive |
|---|---|---|
| Peking University Cancer Hospital & Institute | Peking University Cancer Hospital \& Institute collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status. Receives: Diagnostic Test: Peritoneal metastasis status ascertainment | |
| Zhenjiang First People's Hospital | Zhenjiang First People's Hospital collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status. Receives: Diagnostic Test: Peritoneal metastasis status ascertainment | |
| The First Affiliated Hospital of Zhengzhou University | The First Affiliated Hospital of Zhengzhou University collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status. Receives: Diagnostic Test: Peritoneal metastasis status ascertainment | |
| Nanfang Hospital of Southern Medical University | Nanfang Hospital of Southern Medical University collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status. Receives: Diagnostic Test: Peritoneal metastasis status ascertainment | |
| Guizhou Provincial People's Hospital | Guizhou Provincial People's Hospital collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status. Receives: Diagnostic Test: Peritoneal metastasis status ascertainment | |
| Henan Cancer Hospital | Henan Cancer Hospital collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status. Receives: Diagnostic Test: Peritoneal metastasis status ascertainment | |
| Yunnan Cancer Hospital | Yunnan Cancer Hospital collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status. Receives: Diagnostic Test: Peritoneal metastasis status ascertainment | |
| Guangdong Provincial People's Hospital | Guangdong Provincial People's Hospital collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status. Receives: Diagnostic Test: Peritoneal metastasis status ascertainment | |
| Guangzhou Medical University | Affiliated Cancer Hospital and Institute of Guangzhou Medical University collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status. Receives: Diagnostic Test: Peritoneal metastasis status ascertainment | |
| Fujian Medical University Union Hospital | Fujian Medical University Union Hospital collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status. Receives: Diagnostic Test: Peritoneal metastasis status ascertainment | |
| Shanxi Province Cancer Hospital | Shanxi Province Cancer Hospital collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status. Receives: Diagnostic Test: Peritoneal metastasis status ascertainment | |
| Sun Yat-sen University | Sun Yat-sen University collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status. Receives: Diagnostic Test: Peritoneal metastasis status ascertainment | |
| Scientific Institute San Raffaele | Scientific Institute San Raffaele collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status. Receives: Diagnostic Test: Peritoneal metastasis status ascertainment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The aera under the receiver operating characteristic curve (AUC) of intelligent analysis system
AUC of the intelligent analysis system in predicting peritoneal metastasis for gastric cancer.
Measured: three months
Secondary outcomes (1)
The accuray of intelligent analysis system in predicting peritoneal metastasis
The agreement between the prediction outcome of intelligent analysis system and the golden standard of peritoneal metastasis.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies 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
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Collaborators
- Peking University Cancer Hospital & Institute, Zhenjiang First People's Hospital, The First Affiliated Hospital of Zhengzhou University, Nanfang Hospital, Southern Medical University, Guizhou Provincial People's Hospital, Henan Cancer Hospital, Yunnan Cancer Hospital, Guangdong Provincial People's Hospital, Guangzhou Medical University, Fujian Medical University Union Hospital, Shanxi Province Cancer Hospital, Sun Yat-sen University, Beihang University, Scientific Institute San Raffaele
- Responsible party
- Principal investigator, Di Dong, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722275
- Sponsor's protocol ID
- CASMI003
- Status last verified
- Feb 2023
- First submitted
- 30 Dec 2022
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Smyth EC, Verheij M, Allum W, Cunningham D, Cervantes A, Arnold D; ESMO Guidelines Committee. Gastric cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016 Sep;27(suppl 5):v38-v49. doi: 10.1093/annonc/mdw350. No abstract available.
PubMed 27664260Ajani JA, D'Amico TA, Bentrem DJ, Chao J, Cooke D, Corvera C, Das P, Enzinger PC, Enzler T, Fanta P, Farjah F, Gerdes H, Gibson MK, Hochwald S, Hofstetter WL, Ilson DH, Keswani RN, Kim S, Kleinberg LR, Klempner SJ, Lacy J, Ly QP, Matkowskyj KA, McNamara M, Mulcahy MF, Outlaw D, Park H, Perry KA, Pimiento J, Poultsides GA, Reznik S, Roses RE, Strong VE, Su S, Wang HL, Wiesner G, Willett CG, Yakoub D, Yoon H, McMillian N, Pluchino LA. Gastric Cancer, Version 2.2022, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2022 Feb;20(2):167-192. doi: 10.6004/jnccn.2022.0008.
PubMed 35130500Hur H, Lee HH, Jung H, Song KY, Jeon HM, Park CH. Predicting factors of unexpected peritoneal seeding in locally advanced gastric cancer: indications for staging laparoscopy. J Surg Oncol. 2010 Dec 1;102(7):753-7. doi: 10.1002/jso.21685.
PubMed 20812349Burbidge S, Mahady K, Naik K. The role of CT and staging laparoscopy in the staging of gastric cancer. Clin Radiol. 2013 Mar;68(3):251-5. doi: 10.1016/j.crad.2012.07.015. Epub 2012 Sep 14.
PubMed 22985749Dong D, Tang L, Li ZY, Fang MJ, Gao JB, Shan XH, Ying XJ, Sun YS, Fu J, Wang XX, Li LM, Li ZH, Zhang DF, Zhang Y, Li ZM, Shan F, Bu ZD, Tian J, Ji JF. Development and validation of an individualized nomogram to identify occult peritoneal metastasis in patients with advanced gastric cancer. Ann Oncol. 2019 Mar 1;30(3):431-438. doi: 10.1093/annonc/mdz001.
PubMed 30689702
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Peritoneal Metastasis for Gastric Cancer Based on Radiomics: a Multi-center Prospective Study
- ClinicalTrials.gov ID
- NCT05722275
- Acronym / sponsor ID
- CASMI003
- Conditions
- Gastric Cancer, Peritoneal Metastases
- Keywords
- Artificial Intelligence, Classification, Gastric Cancer, Peritoneal Metastases, Computed Tomography, Radiomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Collaborators
- Peking University Cancer Hospital & Institute, Zhenjiang First People's Hospital, The First Affiliated Hospital of Zhengzhou University, Nanfang Hospital, Southern Medical University, Guizhou Provincial People's Hospital, Henan Cancer Hospital, Yunnan Cancer Hospital, Guangdong Provincial People's Hospital, Guangzhou Medical University, Fujian Medical University Union Hospital, Shanxi Province Cancer Hospital, Sun Yat-sen University, Beihang University, Scientific Institute San Raffaele
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Feb 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.
Peritoneal metastasis of gastric cancer is difficult to be detected in time, thus delaying treatment. Based on the conventional CT images of gastric cancer, this study plans to develop, improve and validate an intelligent analysis system based on radiomics. By extracting and combining the radiomics features related to peritoneal metastasis of gastric cancer, the intelligent analysis system could predict the risk of peritoneal metastasis, and provide personalized decision suggestions for the treatment of gastric cancer.
Detailed description
Peritoneal metastasis of gastric cancer is difficult to be detected in time, thus delaying treatment. Based on the conventional CT images of gastric cancer, this study plans to develop, improve and validate an intelligent analysis system based on radiomics. By extracting and combining the radiomics features related to peritoneal metastasis of gastric cancer, the intelligent analysis system could predict the risk of peritoneal metastasis, and provide personalized decision suggestions for the treatment of gastric cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Peking University Cancer Hospital & Institute | – | Diagnostic Test: Peritoneal metastasis status ascertainmentPeking University Cancer Hospital \& Institute collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status. |
| Zhenjiang First People's Hospital | – | Diagnostic Test: Peritoneal metastasis status ascertainmentZhenjiang First People's Hospital collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status. |
| The First Affiliated Hospital of Zhengzhou University | – | Diagnostic Test: Peritoneal metastasis status ascertainmentThe First Affiliated Hospital of Zhengzhou University collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status. |
| Nanfang Hospital of Southern Medical University | – | Diagnostic Test: Peritoneal metastasis status ascertainmentNanfang Hospital of Southern Medical University collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status. |
| Guizhou Provincial People's Hospital | – | Diagnostic Test: Peritoneal metastasis status ascertainmentGuizhou Provincial People's Hospital collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status. |
| Henan Cancer Hospital | – | Diagnostic Test: Peritoneal metastasis status ascertainmentHenan Cancer Hospital collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status. |
| Yunnan Cancer Hospital | – | Diagnostic Test: Peritoneal metastasis status ascertainmentYunnan Cancer Hospital collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status. |
| Guangdong Provincial People's Hospital | – | Diagnostic Test: Peritoneal metastasis status ascertainmentGuangdong Provincial People's Hospital collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status. |
| Guangzhou Medical University | – | Diagnostic Test: Peritoneal metastasis status ascertainmentAffiliated Cancer Hospital and Institute of Guangzhou Medical University collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status. |
| Fujian Medical University Union Hospital | – | Diagnostic Test: Peritoneal metastasis status ascertainmentFujian Medical University Union Hospital collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status. |
| Shanxi Province Cancer Hospital | – | Diagnostic Test: Peritoneal metastasis status ascertainmentShanxi Province Cancer Hospital collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status. |
| Sun Yat-sen University | – | Diagnostic Test: Peritoneal metastasis status ascertainmentSun Yat-sen University collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status. |
| Scientific Institute San Raffaele | – | Diagnostic Test: Peritoneal metastasis status ascertainmentScientific Institute San Raffaele collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All included patients are initially diagnosed as peritoneal metastasis-negative by CT, but later confirmed with the actual peritoneal metastasis status in laparoscopic exploration.
Key inclusion criteria (4 listed)
- (1) diagnosed advanced gastric cancer (≥cT3) by endoscopy-biopsy pathology, combined with CT and/or endoscopic ultrasound;
- (2) with both enhanced CT and laparoscopy;
- (3) without typical peritoneal metastasis indications in CT (diffuse omental nodules or omental cake, large amount of ascites, obvious irregular thickening with high peritoneal enhancement);
- (4) without other evidence of distant metastasis, and no stage IV features on CT.
Key exclusion criteria (4 listed)
- (1) previous abdominal surgery;
- (2) previous abdominal malignancies or inflammatory diseases;
- (3) time intervals between CT and laparoscopy longer than 2 weeks;
- (4) CT image artifacts that undermine peritoneal lesion assessment.
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 |
|---|---|---|
| Peritoneal metastasis status ascertainmentEach participant with gastric cancer will undergo enhanced CT examination for detection of peritoneal metastasis. Within two weeks of CT examination, the participant will undergo diagnostic laparoscopy to confirm the status of peritoneal metastasis. | Diagnostic test | Fujian Medical University Union Hospital, Guangdong Provincial People's Hospital, Guangzhou Medical University, Guizhou Provincial People's Hospital, Henan Cancer Hospital, Nanfang Hospital of Southern Medical University, Peking University Cancer Hospital & Institute, Scientific Institute San Raffaele, Shanxi Province Cancer Hospital, Sun Yat-sen University, The First Affiliated Hospital of Zhengzhou University, Yunnan Cancer Hospital, Zhenjiang First People's Hospital |
Primary outcome
The aera under the receiver operating characteristic curve (AUC) of intelligent analysis system
Time frame: three months
AUC of the intelligent analysis system in predicting peritoneal metastasis for gastric cancer.
1 secondary outcome
The accuray of intelligent analysis system in predicting peritoneal metastasis
Time frame: three months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Background: PubMed 27664260Smyth EC, Verheij M, Allum W, Cunningham D, Cervantes A, Arnold D; ESMO Guidelines Committee. Gastric cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016 Sep;27(suppl 5):v38-v49. doi: 10.1093/annonc/mdw350. No abstract available.
- Background: PubMed 35130500Ajani JA, D'Amico TA, Bentrem DJ, Chao J, Cooke D, Corvera C, Das P, Enzinger PC, Enzler T, Fanta P, Farjah F, Gerdes H, Gibson MK, Hochwald S, Hofstetter WL, Ilson DH, Keswani RN, Kim S, Kleinberg LR, Klempner SJ, Lacy J, Ly QP, Matkowskyj KA, McNamara M, Mulcahy MF, Outlaw D, Park H, Perry KA, Pimiento J, Poultsides GA, Reznik S, Roses RE, Strong VE, Su S, Wang HL, Wiesner G, Willett CG, Yakoub D, Yoon H, McMillian N, Pluchino LA. Gastric Cancer, Version 2.2022, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2022 Feb;20(2):167-192. doi: 10.6004/jnccn.2022.0008.
- Background: PubMed 20812349Hur H, Lee HH, Jung H, Song KY, Jeon HM, Park CH. Predicting factors of unexpected peritoneal seeding in locally advanced gastric cancer: indications for staging laparoscopy. J Surg Oncol. 2010 Dec 1;102(7):753-7. doi: 10.1002/jso.21685.
- Background: PubMed 22985749Burbidge S, Mahady K, Naik K. The role of CT and staging laparoscopy in the staging of gastric cancer. Clin Radiol. 2013 Mar;68(3):251-5. doi: 10.1016/j.crad.2012.07.015. Epub 2012 Sep 14.
- Results publication: PubMed 30689702Dong D, Tang L, Li ZY, Fang MJ, Gao JB, Shan XH, Ying XJ, Sun YS, Fu J, Wang XX, Li LM, Li ZH, Zhang DF, Zhang Y, Li ZM, Shan F, Bu ZD, Tian J, Ji JF. Development and validation of an individualized nomogram to identify occult peritoneal metastasis in patients with advanced gastric cancer. Ann Oncol. 2019 Mar 1;30(3):431-438. doi: 10.1093/annonc/mdz001.
- Individual participant dataSharing planned: Undecided
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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.
Yali Zang, Ph.D contact
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Peritoneal Metastases, run by Chinese Academy of Sciences at 13 sites in 2 countries.
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 4 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: looking for participants now, as of the sponsor's last update on 14 Feb 2023. 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 China, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Di Dong, Ph.D (+86 010-82618465, di.dong@ia.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The aera under the receiver operating characteristic curve (AUC) of intelligent analysis system (time frame: three months). 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 NCT05722275, which also lists 5 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 14 Feb 2023.