Prediction of Peritoneal Metastasis for Gastric Cancer Based on Radiomics
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Diagnostic Test: Peritoneal metastasis status ascertainment
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.
|
| 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. |
Diagnostic Test: Peritoneal metastasis status ascertainment
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.
|
| 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. |
Diagnostic Test: Peritoneal metastasis status ascertainment
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.
|
| 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. |
Diagnostic Test: Peritoneal metastasis status ascertainment
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.
|
| 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. |
Diagnostic Test: Peritoneal metastasis status ascertainment
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.
|
| 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. |
Diagnostic Test: Peritoneal metastasis status ascertainment
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.
|
| 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. |
Diagnostic Test: Peritoneal metastasis status ascertainment
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.
|
| 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. |
Diagnostic Test: Peritoneal metastasis status ascertainment
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.
|
| 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. |
Diagnostic Test: Peritoneal metastasis status ascertainment
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.
|
| 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. |
Diagnostic Test: Peritoneal metastasis status ascertainment
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.
|
| 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. |
Diagnostic Test: Peritoneal metastasis status ascertainment
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.
|
| 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. |
Diagnostic Test: Peritoneal metastasis status ascertainment
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.
|
| 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. |
Diagnostic Test: Peritoneal metastasis status ascertainment
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.
|
Outcome Measures
Primary Outcome Measures
- The aera under the receiver operating characteristic curve (AUC) of intelligent analysis system [three months]
AUC of the intelligent analysis system in predicting peritoneal metastasis for gastric cancer.
Secondary Outcome Measures
- The accuray of intelligent analysis system in predicting peritoneal metastasis [three months]
The agreement between the prediction outcome of intelligent analysis system and the golden standard of peritoneal metastasis.
Other Outcome Measures
- The statistical significance of intelligent analysis system in risk stratification [Three years]
Statistical significance (P value) of progression-free survival (PFS) in gastric cancer patients between high-risk and low-risk group identified by the intelligent analysis system.
- Progression-free survival time [Three years]
The progression-free survival time in patient subgroups stratified by the intelligent analysis system.
- Overall survival [Three years]
The overall survival time in patient subgroups stratified by the intelligent analysis system.
Eligibility Criteria
Criteria
Inclusion Criteria:
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(1) diagnosed advanced gastric cancer (≥cT3) by endoscopy-biopsy pathology, combined with CT and/or endoscopic ultrasound;
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(2) with both enhanced CT and laparoscopy;
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(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);
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(4) without other evidence of distant metastasis, and no stage IV features on CT.
Exclusion Criteria:
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(1) previous abdominal surgery;
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(2) previous abdominal malignancies or inflammatory diseases;
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(3) time intervals between CT and laparoscopy longer than 2 weeks;
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(4) CT image artifacts that undermine peritoneal lesion assessment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University Cancer Hospital & Institute | Beijing | China | ||
| 2 | Fujian Medical University Union Hospital | Fuzhou | China | ||
| 3 | Affiliated Cancer Hospital and Institute of Guangzhou Medical University | Guangzhou | China | ||
| 4 | Guangdong Provincial People's Hospital | Guangzhou | China | ||
| 5 | Nanfang Hospital of Southern Medical University | Guangzhou | China | ||
| 6 | Sun Yat-Sen University Cancer Hospital | Guangzhou | China | ||
| 7 | Guizhou Provincial People's Hospital | Guiyang | China | ||
| 8 | Yunnan Cancer Hospital | Kunming | China | ||
| 9 | Shanxi Province Cancer Hospital | Taiyuan | China | ||
| 10 | Henan Cancer Hospital | Zhengzhou | China | ||
| 11 | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | China | ||
| 12 | Zhenjiang First People's Hospital | Zhenjiang | China | ||
| 13 | Scientific Institute San Raffaele | Milan | Italy |
Sponsors and Collaborators
- Chinese Academy of Sciences
- Peking University Cancer Hospital & Institute
- Zhenjiang First People's Hospital
- The First Affiliated Hospital of Zhengzhou University
- Nanfang Hospital of 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
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Ajani 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.
- Burbidge 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.
- Hur 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.
- 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.
- CASMI003