Rectal CancerNCT05572151
Determining the Optimal Examined Lymph Node for Accurate Staging and Long-term Survival in Rectal Cancer
An observational study of Rectal Cancer, run by The Second Affiliated Hospital of Harbin Medical University.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- lymph node number
- Type of treatment
- Surgery or procedure
- How many people
- 7,694 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2009to 31 Dec 2018
- 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 90 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- Rectal cancer patients in stage I-III who underwent surgical resection for first primary rectal cancer with at least one lymph node were eligible
Who cannot join
- Patients with missing values on lymph node count and clinical features were excluded
About this study
Official title: 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
Read the 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)
- Conditions
- Rectal Cancer
- Being tested
- lymph node number
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lymph node numberProcedure or surgery
Lymph nodes were harvested during surgical resection of rectal cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
lymph node number
lymph nodes were harvested during surgical resection of rectal cancer
Measured: during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start1 Jan 2009
- Primary completion10 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies 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
- 7,694 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuai Jiao, The Second Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572151
- Sponsor's protocol ID
- 82100598
- Status last verified
- Oct 2022
- First submitted
- 4 Oct 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Del Paggio JC, Peng Y, Wei X, Nanji S, MacDonald PH, Krishnan Nair C, Booth CM. Population-based study to re-evaluate optimal lymph node yield in colonic cancer. Br J Surg. 2017 Jul;104(8):1087-1096. doi: 10.1002/bjs.10540. Epub 2017 May 24.
PubMed 28542954Guan X, Jiao S, Wen R, Yu G, Liu J, Miao D, Wei R, Zhang W, Hao L, Zhou L, Lou Z, Liu S, Zhao E, Wang G, Zhang W, Wang X. Optimal examined lymph node number for accurate staging and long-term survival in rectal cancer: a population-based study. Int J Surg. 2023 Aug 1;109(8):2241-2248. doi: 10.1097/JS9.0000000000000320.
PubMed 37428195
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05572151
- Acronym / sponsor ID
- 82100598
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,694 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 10 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 7 Oct 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.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Rectal cancer patients in stage I-III who underwent surgical resection for first primary rectal cancer with at least one lymph node were eligible
Key exclusion criteria (1 listed)
- Patients with missing values on lymph node count and clinical features were excluded
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 |
|---|---|---|
| lymph node numberLymph nodes were harvested during surgical resection of rectal cancer | Procedure or surgery | – |
Primary outcome
lymph node number
Time frame: during the surgery
lymph nodes were harvested during surgical resection of rectal cancer
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 7 Oct 2022.
- Background: PubMed 28542954Del Paggio JC, Peng Y, Wei X, Nanji S, MacDonald PH, Krishnan Nair C, Booth CM. Population-based study to re-evaluate optimal lymph node yield in colonic cancer. Br J Surg. 2017 Jul;104(8):1087-1096. doi: 10.1002/bjs.10540. Epub 2017 May 24.
- Derived from this study: PubMed 37428195Guan X, Jiao S, Wen R, Yu G, Liu J, Miao D, Wei R, Zhang W, Hao L, Zhou L, Lou Z, Liu S, Zhao E, Wang G, Zhang W, Wang X. Optimal examined lymph node number for accurate staging and long-term survival in rectal cancer: a population-based study. Int J Surg. 2023 Aug 1;109(8):2241-2248. doi: 10.1097/JS9.0000000000000320.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by The Second Affiliated Hospital of Harbin Medical University.
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 1 inclusion and 1 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 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
lymph node number (time frame: during the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05572151, which also lists 2 linked publications.
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 7 Oct 2022; AzTrials last refreshed its copy on 29 Oct 2026.