Gastrointestinal Cancers - StomachNCT05620537
A Novel Nomogram to Predict the Postoperative Overall Survival in Gastrointestinal Cancer Patients
An observational study of Gastrointestinal Cancers - Stomach and Gastrointestinal Cancers - Colorectal, run by Wang Xinying at 1 site in China.
Trial summary
This multicenter retrospectively observational cohort study was conducted on participants with histologically confirmed gastric and colorectal cancer who underwent radical surgery in 11 medical centers in China from August 1, 2015, to June 31, 2018. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastrointestinal Cancers - Stomach, Gastrointestinal Cancers - Colorectal, Prognosis
- What is being tested?
- observation
- How many people
- 808 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2022to 25 Nov 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participants are who with histologically confirmed gastric and colorectal cancer who underwent radical surgery in 11 medical centers in China from August 1, 2015, to June 31, 2018.
Who may be able to join
- 18-80 years old
- postoperative pathological diagnosis of gastric or colorectal adenocarcinoma
- underwent radical surgery
- TNM stage ranged from stage I to stage III
Who cannot join
- NRS 2002 or PG-SGA data was missing
- pathological diagnosis of gastric stump cancer, cancer in situ, or pin-point cancer
- in-hospital death or death within 30 days after surgery
- preoperative neoadjuvant therapy
- preoperative endoscopic surgery
- the previous history of other malignant tumors
- pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Nomogram to Predict the Postoperative 1-, 3-, and 5-year Overall Sur-vival in Gastrointestinal Cancer Patients: A Retrospective Multicenter Cohort Study
This multicenter retrospectively observational cohort study was conducted on participants with histologically confirmed gastric and colorectal cancer who underwent radical surgery in 11 medical centers in China from August 1, 2015, to June 31, 2018. Baseline clinicopathologic data and nutritional status assessments including Nutrition Risk Screening 2002 (NRS 2002) score and Patient-generated Subjective Global Assessment (PG-SGA) rating were collected. Variables will be screened using the least absolute shrinkage and selection operator (LASSO) regression model and Cox regression analysis. Internal and external validations will be performed via the receiver operating curve (ROC), the area under the curve (AUC), the concordance index (C-index), calibration plots, decision curve analysis (DCA), and Five folds cross-validation by 200 times.
Read the detailed description
- Study design and patients This study is a multicenter retrospectively observational cohort study, which collected and followed up the patients with gastric cancer and colorectal cancer in 11 Chinese hospitals from August 1, 2015, to June 31, 2018. The eight sites of these were recruited as a training cohort, and the other three sites were recruited as an external validation cohort (Supplement Table 1). The inclusion criteria for both cohorts were complied with: 1) 18-80 years old; 2) postoperative pathological diagnosis of gastric or colorectal adenocarcinoma; 3) underwent radical surgery; 4) TNM stage ranged from stage I to stage III. The exclusion criteria included: 1) NRS 2002 or PG-SGA data was missing; 2) pathological diagnosis of gastric stump cancer, cancer in situ, or pin-point cancer; 3) in-hospital death or death within 30 days after surgery; 4) preoperative neoadjuvant therapy; 5) preoperative endoscopic surgery; 6) the previous history of other malignant tumors; 7) pregnancy. This study was approved by the Ethics Committee of each hospital.
- Data collection The following clinical data were collected in this study: demographic characteristics (age, sex, height, weight, and BMI), age-adjusted Charlson Comorbidity Index (aCCI), NRS 2002 score, PG-SGA rating, pathological characteristics (tumor stage, type, differentiation, tumor size, and tumor vol-ume), surgical characteristics (operation type and intraoperative blood loss), hematological indicators [carcinoembryonic antigen (CEA), cancer antigen19-9 (CA19-9), albumin, pre-albumin, blood glucose, triglycerides (TG), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, blood urea nitrogen (BUN), serum creatinine, hemoglobin, and white blood cell], and other clinical characteristics (postoperative complication and postoperative infection). These candidate variables were derived from previous studies and clinical experience. We obtained tumor staging from electronic medical records and pathological reports using the American Joint Committee on Cancer (AJCC) 8th edition. Tumor volume was derived from tumor length, width, and height using the following formulas: V = 1/2 × a × b2 or V = π/6 × a × b × c.
- Nutritional status assessments All the centers routinely perform nutritional status assessments on admission by the NRS 2002 and PG-SGA. We collected the NRS 2002 score and PG-SGA rating from the electronic medical record system. 3.1 NRS 2002 NRS 2002 was used to estimate nutritional risk, accounting for inadequate nutritional status (low, moderate, or severe) and illness severity (low, moderate, or severe), with a 70-year age adjustment. The NRS 2002 score ranges from 0 to 7. For the NRS 2002, we employed three categories: no nutritional risk (<3), nutritional risk (3-4), and severe nutritional risk (≥5). 3.2 PG-SGA The PG-SGA, a nutritional status assessment tool based on the SGA, was developed exclusively for cancer patients. This includes self-evaluation by patients as well as evaluation by medical professionals. The seven components that make up the core content are weight, food intake, symptoms, functional ability, illness and its relationship to nutritional needs, metabolic demand (stress), and physical examination. The first four components were assessed by patients, while the final three were assessed by medical professionals. Physical examination was used to determine muscular exhaustion, subcutaneous fat thickness, and edema. Decreased mass and tone in temporal regions, deltoids, and quads indicated muscular exhaustion. The triceps and midaxillary lines at the level of the lower ribs were studied for subcutaneous fat depletion. Edema was checked on the ankles. Patients were categorized as well-nourished (A), moderately malnourished (B), or severely malnourished (C) based on the foregoing assessments.
- Study Outcome The primary outcome of this study was OS, defined as the time from the date of surgery to the end of follow-up or death. Follow-up information was mainly collected through the follow-up database of gastric and colorectal cancer of each center combined with telephone, outpatient, or inpatient follow-ups.
- Statistical methods Measurement data will be expressed as means and standard deviations (SD), while enumeration data will be expressed as frequencies and respective percentages. Hematological indicators will be converted to categorical variables while analyzed. Variables will be initially screened using the least absolute shrinkage and selection operator (LASSO) regression. The variables with minimum λ will be further screened using univariate and multivariate Cox regression analysis to identify independent predictors. Then we will build a prediction model by multivariate Cox regression model and plot the nomogram. For user convenience, we will also create a dynamic nomogram webpage. Discrimination of the model will be assessed using the receiver operating curve (ROC), the area under the curve (AUC), and the concordance index (C-index). Calibration plots will be used to assess the calibration of the model. Decision curve analysis (DCA) will be used to evaluate the clinical utility of the model. The same assessments will be performed with an external validation cohort. Internal validation of the model will be performed using Five folds cross-validation by 200 times. The cut-off values of the nomogram score which categorize patients into three categories (low-risk, middle-risk, and high-risk) will be calculated by X-tile 3.6.1 version (https://medicine.yale.edu/lab/rimm/research/software/). Kaplan-Meier analysis will be used to do survival analyses. R 4.2.0 version (http://www.r-project.org) will be used for statistical analyses of this study. A two-tailed p <0.05 will be considered statistically significant.
- Conditions
- Gastrointestinal Cancers - Stomach, Gastrointestinal Cancers - Colorectal, Prognosis, Survival Analysis, Nutrition Assessment
- Being tested
- observation
- Keywords
- Gastrointestinal Cancer, NRS 2002, Postoperative survival, Nomogram, multicenter study
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
There are no interventions.
| Study group | Role | What they receive |
|---|---|---|
| Gastrointestinal cancer patients cohort | Not described Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative overall survival
It is the time from the date of surgery to the end of follow-up or death.
Measured: 2022-02-01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start10 Nov 2022
- Primary completion25 Nov 2022
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Cancers - StomachStudies 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
- Retrospective
- Enrolment
- 808 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wang Xinying
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Cancer Institute & Hospital, Xijing Hospital, Northern Jiangsu People's Hospital, The Affiliated Hospital of Qingdao University, Shanghai 10th People's Hospital, West China Hospital, First Affiliated Hospital of Kunming Medical University, The Second Affiliated Hospital of Harbin Medical University, Peking Union Medical College Hospital, Chinese PLA General Hospital
- Responsible party
- Sponsor-investigator, Wang Xinying, Jinling Hospital, China
- Investigators
- Xinying Wang, M.D., Principal investigator, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620537
- Sponsor's protocol ID
- 2022JinlingHospital-cohort2
- Status last verified
- Feb 2023
- First submitted
- 10 Nov 2022
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data and analytic code will be made available upon request pending application and approval by the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Nomogram to Predict the Postoperative 1-, 3-, and 5-year Overall Sur-vival in Gastrointestinal Cancer Patients: A Retrospective Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT05620537
- Acronym / sponsor ID
- 2022JinlingHospital-cohort2
- Conditions
- Gastrointestinal Cancers - Stomach, Gastrointestinal Cancers - Colorectal, Prognosis, Survival Analysis, Nutrition Assessment
- Keywords
- Gastrointestinal Cancer, NRS 2002, Postoperative survival, Nomogram, multicenter study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 808 participants (actual)
- Lead sponsor
- Wang XinyingUniversity, hospital or other
- Collaborators
- Jiangsu Cancer Institute & Hospital, Xijing Hospital, Northern Jiangsu People's Hospital, The Affiliated Hospital of Qingdao University, Shanghai 10th People's Hospital, West China Hospital, First Affiliated Hospital of Kunming Medical University, The Second Affiliated Hospital of Harbin Medical University, Peking Union Medical College Hospital, Chinese PLA General Hospital
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 17 Nov 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.
This multicenter retrospectively observational cohort study was conducted on participants with histologically confirmed gastric and colorectal cancer who underwent radical surgery in 11 medical centers in China from August 1, 2015, to June 31, 2018. Baseline clinicopathologic data and nutritional status assessments including Nutrition Risk Screening 2002 (NRS 2002) score and Patient-generated Subjective Global Assessment (PG-SGA) rating were collected. Variables will be screened using the least absolute shrinkage and selection operator (LASSO) regression model and Cox regression analysis. Internal and external validations will be performed via the receiver operating curve (ROC), the area under the curve (AUC), the concordance index (C-index), calibration plots, decision curve analysis (DCA), and Five folds cross-validation by 200 times.
Detailed description
- Study design and patients This study is a multicenter retrospectively observational cohort study, which collected and followed up the patients with gastric cancer and colorectal cancer in 11 Chinese hospitals from August 1, 2015, to June 31, 2018. The eight sites of these were recruited as a training cohort, and the other three sites were recruited as an external validation cohort (Supplement Table 1). The inclusion criteria for both cohorts were complied with: 1) 18-80 years old; 2) postoperative pathological diagnosis of gastric or colorectal adenocarcinoma; 3) underwent radical surgery; 4) TNM stage ranged from stage I to stage III. The exclusion criteria included: 1) NRS 2002 or PG-SGA data was missing; 2) pathological diagnosis of gastric stump cancer, cancer in situ, or pin-point cancer; 3) in-hospital death or death within 30 days after surgery; 4) preoperative neoadjuvant therapy; 5) preoperative endoscopic surgery; 6) the previous history of other malignant tumors; 7) pregnancy. This study was approved by the Ethics Committee of each hospital.
- Data collection The following clinical data were collected in this study: demographic characteristics (age, sex, height, weight, and BMI), age-adjusted Charlson Comorbidity Index (aCCI), NRS 2002 score, PG-SGA rating, pathological characteristics (tumor stage, type, differentiation, tumor size, and tumor vol-ume), surgical characteristics (operation type and intraoperative blood loss), hematological indicators [carcinoembryonic antigen (CEA), cancer antigen19-9 (CA19-9), albumin, pre-albumin, blood glucose, triglycerides (TG), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, blood urea nitrogen (BUN), serum creatinine, hemoglobin, and white blood cell], and other clinical characteristics (postoperative complication and postoperative infection). These candidate variables were derived from previous studies and clinical experience. We obtained tumor staging from electronic medical records and pathological reports using the American Joint Committee on Cancer (AJCC) 8th edition. Tumor volume was derived from tumor length, width, and height using the following formulas: V = 1/2 × a × b2 or V = π/6 × a × b × c.
- Nutritional status assessments All the centers routinely perform nutritional status assessments on admission by the NRS 2002 and PG-SGA. We collected the NRS 2002 score and PG-SGA rating from the electronic medical record system. 3.1 NRS 2002 NRS 2002 was used to estimate nutritional risk, accounting for inadequate nutritional status (low, moderate, or severe) and illness severity (low, moderate, or severe), with a 70-year age adjustment. The NRS 2002 score ranges from 0 to 7. For the NRS 2002, we employed three categories: no nutritional risk (<3), nutritional risk (3-4), and severe nutritional risk (≥5). 3.2 PG-SGA The PG-SGA, a nutritional status assessment tool based on the SGA, was developed exclusively for cancer patients. This includes self-evaluation by patients as well as evaluation by medical professionals. The seven components that make up the core content are weight, food intake, symptoms, functional ability, illness and its relationship to nutritional needs, metabolic demand (stress), and physical examination. The first four components were assessed by patients, while the final three were assessed by medical professionals. Physical examination was used to determine muscular exhaustion, subcutaneous fat thickness, and edema. Decreased mass and tone in temporal regions, deltoids, and quads indicated muscular exhaustion. The triceps and midaxillary lines at the level of the lower ribs were studied for subcutaneous fat depletion. Edema was checked on the ankles. Patients were categorized as well-nourished (A), moderately malnourished (B), or severely malnourished (C) based on the foregoing assessments.
- Study Outcome The primary outcome of this study was OS, defined as the time from the date of surgery to the end of follow-up or death. Follow-up information was mainly collected through the follow-up database of gastric and colorectal cancer of each center combined with telephone, outpatient, or inpatient follow-ups.
- Statistical methods Measurement data will be expressed as means and standard deviations (SD), while enumeration data will be expressed as frequencies and respective percentages. Hematological indicators will be converted to categorical variables while analyzed. Variables will be initially screened using the least absolute shrinkage and selection operator (LASSO) regression. The variables with minimum λ will be further screened using univariate and multivariate Cox regression analysis to identify independent predictors. Then we will build a prediction model by multivariate Cox regression model and plot the nomogram. For user convenience, we will also create a dynamic nomogram webpage. Discrimination of the model will be assessed using the receiver operating curve (ROC), the area under the curve (AUC), and the concordance index (C-index). Calibration plots will be used to assess the calibration of the model. Decision curve analysis (DCA) will be used to evaluate the clinical utility of the model. The same assessments will be performed with an external validation cohort. Internal validation of the model will be performed using Five folds cross-validation by 200 times. The cut-off values of the nomogram score which categorize patients into three categories (low-risk, middle-risk, and high-risk) will be calculated by X-tile 3.6.1 version (https://medicine.yale.edu/lab/rimm/research/software/). Kaplan-Meier analysis will be used to do survival analyses. R 4.2.0 version (http://www.r-project.org) will be used for statistical analyses of this study. A two-tailed p <0.05 will be considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastrointestinal cancer patients cohort | – | Other: observation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants are who with histologically confirmed gastric and colorectal cancer who underwent radical surgery in 11 medical centers in China from August 1, 2015, to June 31, 2018.
Key inclusion criteria (4 listed)
- 18-80 years old
- postoperative pathological diagnosis of gastric or colorectal adenocarcinoma
- underwent radical surgery
- TNM stage ranged from stage I to stage III
Key exclusion criteria (7 listed)
- NRS 2002 or PG-SGA data was missing
- pathological diagnosis of gastric stump cancer, cancer in situ, or pin-point cancer
- in-hospital death or death within 30 days after surgery
- preoperative neoadjuvant therapy
- preoperative endoscopic surgery
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 |
|---|---|---|
| observationThere are no interventions. | Other | Gastrointestinal cancer patients cohort |
Primary outcome
postoperative overall survival
Time frame: 2022-02-01
It is the time from the date of surgery to the end of follow-up or death.
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 13 Feb 2023.
- Individual participant dataSharing planned: Undecided. Data and analytic code will be made available upon request pending application and approval by the corresponding author.
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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.
Xinying Wang, M.D. principal investigator
Jinling Hospital, China
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 Gastrointestinal Cancers - Stomach and Gastrointestinal Cancers - Colorectal, run by Wang Xinying 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 4 inclusion and 7 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 13 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 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?
postoperative overall survival (time frame: 2022-02-01). 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 13 Feb 2023.