- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05572151
Determining the Optimal Examined Lymph Node for Accurate Staging and Long-term Survival in Rectal Cancer
October 6, 2022 updated by: Shuai Jiao, The Second Affiliated Hospital of Harbin Medical University
Determining the Optimal Examined Lymph Node for Accurate Staging and Long-term Survival in Rectal Cancer: a Population Study of the US Database and a Chinese Multi-institutional Registry
A multi-institutional registry of collected data on patients with rectal cancer who underwent surgical resection between January 2009 and December 2018 at the departments of colorectal surgery of five medical institutions in China
Study Overview
Detailed Description
A multi-institutional registry of collected data on patients with rectal cancer who underwent surgical resection between January 2009 and December 2018 at the departments of colorectal surgery of five medical institutions in China (National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; Changhai Hospital, Naval Medical University; The Second Affiliated Hospital of Harbin Medical University; The Affiliated Tumor Hospital of Harbin Medical University; The Affiliated Tumor Hospital of Guangxi Medical University)
Study Type
Observational
Enrollment (Actual)
7694
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Information about patients (age, sex and year of diagnosis), tumor (TNM stages, histology, size and differentiation), treatments (resection type, chemotherapy), and outcome variables (follow-up time and survival status) were obtained in SEER database and China registry
Description
Inclusion Criteria:
- Rectal cancer patients in stage I-III who underwent surgical resection for first primary rectal cancer with at least one lymph node were eligible
Exclusion Criteria:
- Patients with missing values on lymph node count and clinical features were excluded
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
lymph node number
Time Frame: during the surgery
|
lymph nodes were harvested during surgical resection of rectal cancer
|
during the surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2009
Primary Completion (Actual)
December 10, 2018
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
October 4, 2022
First Submitted That Met QC Criteria
October 6, 2022
First Posted (Actual)
October 7, 2022
Study Record Updates
Last Update Posted (Actual)
October 7, 2022
Last Update Submitted That Met QC Criteria
October 6, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 82100598
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.