Prediction of Peritoneal Metastasis for Gastric Cancer Based on Radiomics

NCT ID: NCT05722275

Last Updated: 2023-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2028-12-31

Brief Summary

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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

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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

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Gastric Cancer Peritoneal Metastases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Peritoneal metastasis status ascertainment

Intervention Type DIAGNOSTIC_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.

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.

Peritoneal metastasis status ascertainment

Intervention Type DIAGNOSTIC_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.

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.

Peritoneal metastasis status ascertainment

Intervention Type DIAGNOSTIC_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.

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.

Peritoneal metastasis status ascertainment

Intervention Type DIAGNOSTIC_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.

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.

Peritoneal metastasis status ascertainment

Intervention Type DIAGNOSTIC_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.

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.

Peritoneal metastasis status ascertainment

Intervention Type DIAGNOSTIC_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.

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.

Peritoneal metastasis status ascertainment

Intervention Type DIAGNOSTIC_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.

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.

Peritoneal metastasis status ascertainment

Intervention Type DIAGNOSTIC_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.

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.

Peritoneal metastasis status ascertainment

Intervention Type DIAGNOSTIC_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.

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.

Peritoneal metastasis status ascertainment

Intervention Type DIAGNOSTIC_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.

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.

Peritoneal metastasis status ascertainment

Intervention Type DIAGNOSTIC_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.

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.

Peritoneal metastasis status ascertainment

Intervention Type DIAGNOSTIC_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.

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.

Peritoneal metastasis status ascertainment

Intervention Type DIAGNOSTIC_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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* (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.

Exclusion Criteria

* (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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Cancer Hospital & Institute

OTHER

Sponsor Role collaborator

Zhenjiang First People's Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role collaborator

Guizhou Provincial People's Hospital

OTHER

Sponsor Role collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role collaborator

Yunnan Cancer Hospital

OTHER

Sponsor Role collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role collaborator

Guangzhou Medical University

OTHER

Sponsor Role collaborator

Fujian Medical University Union Hospital

OTHER

Sponsor Role collaborator

Shanxi Province Cancer Hospital

OTHER

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role collaborator

Beihang University

OTHER

Sponsor Role collaborator

Scientific Institute San Raffaele

OTHER

Sponsor Role collaborator

Chinese Academy of Sciences

OTHER_GOV

Sponsor Role lead

Responsible Party

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Di Dong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking University Cancer Hospital & Institute

Beijing, , China

Site Status RECRUITING

Fujian Medical University Union Hospital

Fuzhou, , China

Site Status RECRUITING

Affiliated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, , China

Site Status RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, , China

Site Status RECRUITING

Nanfang Hospital of Southern Medical University

Guangzhou, , China

Site Status RECRUITING

Sun Yat-Sen University Cancer Hospital

Guangzhou, , China

Site Status RECRUITING

Guizhou Provincial People's Hospital

Guiyang, , China

Site Status RECRUITING

Yunnan Cancer Hospital

Kunming, , China

Site Status RECRUITING

Shanxi Province Cancer Hospital

Taiyuan, , China

Site Status RECRUITING

Henan Cancer Hospital

Zhengzhou, , China

Site Status RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, , China

Site Status RECRUITING

Zhenjiang First People's Hospital

Zhenjiang, , China

Site Status RECRUITING

Scientific Institute San Raffaele

Milan, , Italy

Site Status RECRUITING

Countries

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China Italy

Central Contacts

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Di Dong, Ph.D

Role: CONTACT

+86 010-82618465

Yali Zang, Ph.D

Role: CONTACT

Facility Contacts

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Lei Tang

Role: primary

Changming Huang, MD

Role: primary

Shuzhong Cui, MD

Role: primary

Zaiyi Liu, MD

Role: primary

Guoxin Li

Role: primary

Linquan Tang, MD

Role: primary

Rongping Wang

Role: primary

Zhenhui Li, MD

Role: primary

Yanfen Cui, MD

Role: primary

Jing Li

Role: primary

Jianbo Gao

Role: primary

Xiuhong Shan

Role: primary

Francesco De Cobelli

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 27664260 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35130500 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20812349 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22985749 (View on PubMed)

Dong 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.

Reference Type RESULT
PMID: 30689702 (View on PubMed)

Other Identifiers

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CASMI003

Identifier Type: -

Identifier Source: org_study_id

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