Long-term Heart-specific Mortality in the Presence of Competing Risks Among Patients With Non-metastatic Gastric Adenocarcinoma Undergoing Resection and Chemotherapy (GaCCoR-01)
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| ClinicalTrials.gov Identifier: NCT04820569 |
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Recruitment Status :
Completed
First Posted : March 29, 2021
Last Update Posted : March 29, 2021
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Sponsor:
The First Affiliated Hospital of Anhui Medical University
Information provided by (Responsible Party):
Lei Huang, The First Affiliated Hospital of Anhui Medical University
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Brief Summary:
In this population-based cohort study, data on patients diagnosed with nmGaC in 2004 through 2016, managed with resection and chemotherapy, followed up until the end of 2016, and surviving ≥1 month were retrieved from the US Surveillance, Epidemiology, and End Results-18 Program. Cumulative mortality functions were calculated. Prognostic factors for heart-specific mortality were evaluated using both multivariable-adjusted Fine-Gray subdistribution and cause-specific hazard functions.
| Condition or disease | Intervention/treatment |
|---|---|
| Long-term Heart-specific Mortality in the Presence of Competing Risks Among Patients With Gastric Adenocarcinoma Undergoing Resection and Chemotherapy | Procedure: Resection and chemotherapy |
| Study Type : | Observational [Patient Registry] |
| Actual Enrollment : | 21257 participants |
| Observational Model: | Cohort |
| Time Perspective: | Other |
| Target Follow-Up Duration: | 12 Years |
| Official Title: | Long-term Heart-specific Mortality in the Presence of Competing Risks Among Patients With Non-metastatic Gastric Adenocarcinoma Undergoing Resection and Chemotherapy A Population-based Cohort Study of 21,257 Cases, 2004-2016 |
| Actual Study Start Date : | January 1, 2004 |
| Actual Primary Completion Date : | December 31, 2016 |
| Actual Study Completion Date : | December 31, 2016 |
Primary Outcome Measures :
- Cumulative mortality [ Time Frame: Jan 12, 2020-Mar 5, 2021 ]Cumulative incidence functions (CIFs), which, unlike the standard Kaplan-Meier method, allow for estimation of the incidence of the occurrence of an event while taking competing risks from other causes of death into account, were computed and plotted for cause-specific mortalities.
- Prognostic factors for disease-specific mortalities [ Time Frame: Jan 12, 2020-Mar 5, 2021 ]Evaluated using both multivariable-adjusted Fine-Gray subdistribution and cause-specific hazard functions.
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| Ages Eligible for Study: | 20 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Cases of non-metastatic gastric adenocarcinoma (nmGaC) were defined as patients with microscopically-confirmed first primary invasive adenocarcinoma of the stomach (International Classification of Diseases for Oncology, Third Edition (ICD-O-3) code: C16) without distant metastasis. Only those who underwent resection in January 2004 through December 2016 were included.
Criteria
Cases of non-metastatic gastric adenocarcinoma (nmGaC) were defined as patients with microscopically-confirmed first primary invasive adenocarcinoma of the stomach (International Classification of Diseases for Oncology, Third Edition (ICD-O-3) code: C16) without distant metastasis. Only those who underwent resection in January 2004 through December 2016 were included. Cancers of other histology types including squamous cell carcinoma, gastrointestinal stromal tumor or sarcoma, neuroendocrine tumor or carcinoid, lymphoma, and germ-cell tumor were ineligible, as were patients with non-gastric cancers involving the stomach, with benign or in situ tumors, or with other malignancies before gastric cancer. We further excluded patients with diagnosis based on death certificate only or autopsy, with missing follow-up period, survival status, or cause of death, or with unknown metastasis status. Cancers with distant metastasis were excluded since resection is not routinely recommended for them. Data before 2004 were not included, as the TNM stage information was unavailable. To minimize the effect of perioperative events on survival, we excluded patients surviving <1 month. No restrictions were applied to age, and patients ≥80 years only comprised 5% of those receiving both resection and chemotherapy.
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| Responsible Party: | Lei Huang, Dr., The First Affiliated Hospital of Anhui Medical University |
| ClinicalTrials.gov Identifier: | NCT04820569 |
| Other Study ID Numbers: |
GaCCoR-01 |
| First Posted: | March 29, 2021 Key Record Dates |
| Last Update Posted: | March 29, 2021 |
| Last Verified: | March 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | The Surveillance, Epidemiology, and End Results Program data are available upon reasonable request and with permission of the registry. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |