Clinical trial NCT05001321: Multi-center and Multi-modal Deep Learning Study of Gastric Cancer
Official title: Multi-center and Multi-modal Deep Learning Study of Diagnosis, Therapeutic Outcome and Prognosis of Gastric Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stomach Neoplasms
Keywords: Diagnosis
Prognosis
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
Collaborators: name: The Second Hospital of Shandong University
name: Chaoyang Central Hospital
name: The General Hospital of Fushun Mining Bureau
name: The fourth People's Hospital of Changzhou
name: First Hospital of Jinzhou Medical University
First posted: 2021-08-11
Enrollment: 3300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 3000 gastric cancer patients will participate in the phase I study, they will be divided into training group and internal validation group. 300 gastric cancer patients in five other medical centers will form the external validation group.

Brief summary: To assist postoperative pathological diagnosis and classification of gastric cancer by machine learning; To improve the accuracy of pathological diagnosis of gastric cancer by machine learning; To predict the effectiveness of treatment for gastric cancer by deep learning; To construct a model to predict the survival of gastric cancer patients by multimodal deep learning.


Eligibility criteria: Inclusion Criteria:

* The diagnosis of gastric cancer was confirmed by pathology;
* Preoperative enhanced abdominal CT;
* Available detailed clinical and pathological data;
* Integrated follow-up data.

Exclusion Criteria:

* The patients had severe underlying disease;
* Overall survival was less than 3 months;
* No detailed information could be collected.

Primary outcomes:
measure: Maximum diameter of tumor
timeFrame: 1 day
measure: Growth pattern
timeFrame: 1 day
measure: Enhancement pattern
timeFrame: 1 day
measure: Enhancement degree
timeFrame: 1 day
measure: Nucleus size
timeFrame: 1 day
measure: Nucleus shape
timeFrame: 1 day
measure: Distribution of pixel intensity
timeFrame: 1 day
measure: Texture of nuclei
timeFrame: 1 day
Secondary outcomes:
measure: Survival status
timeFrame: 1 day
measure: Overall survival
timeFrame: 1 day
measure: Recurrence/metastasis
timeFrame: 1 day
Other outcomes:
Locations:
city: Changzhou
country: China
facility: The fourth People's Hospital of Changzhou
state: Jiangsu
city: Chaoyang
country: China
facility: Chaoyang Central Hospital
state: Liaoning
city: Fushun
country: China
facility: The General Hospital of Fushun Mining Bureau
state: Liaoning
city: Jinzhou
country: China
facility: First Hospital of Jinzhou Medical University
state: Liaoning
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Liaoning
city: Ji'nan
country: China
facility: The Second Hospital of Shandong University
state: Shandong
Study officials:
affiliation: First Hospital of China Medical University
name: Kai Li, MD
role: PRINCIPAL_INVESTIGATOR
References: