Rectum CancerNCT05493930
A Lymph Node Metastasis Predictor (LN-MASTER) in Rectal Cancer
An observational study of Rectum Cancer, run by Peking Union Medical College.
Trial summary
In this study, we aim to develop and validate an easy-to-use machine learning prediction model to preoperatively identify the lymph node metastasis status for rectal cancer patients by using these clinical data from three hospitals. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectum Cancer
- What is being tested?
- The hospital where the treatment is performed
- How many people
- 6,578 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 31 Dec 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: rectal cancer patients with/without lymph node metastasis
Who may be able to join
- American Joint Committee on Cancer (AJCC) stages I -III rectal cancer
- underwent radical surgery
Who cannot join
- other malignancies
- received treatment with endoscopic submucosal dissection (ESD)
- metastatic lesions
- did not undergo lymph node dissection
- had unavailable assessed lymph node status
- received neoadjuvant therapy
About this study
Official title: An Easy-to-use Artificial Intelligence Preoperative Lymph Node Metastasis Predictor (LN-MASTER) in Rectal Cancer Based on a Privacy-preserving Computing Platform: Multicenter Retrospective Cohort Study
In this study, we aim to develop and validate an easy-to-use machine learning prediction model to preoperatively identify the lymph node metastasis status for rectal cancer patients by using these clinical data from three hospitals.
Read the detailed description
In this study, participants were recruited from the Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College (development set), Changhai Hospital, Naval Medical University (external validation set 1), and the Second Affiliated Hospital of Harbin Medical University (external validation set 2), between January 1, 2016, and December 31, 2020. According to the inclusion criteria, participants who (a) were in American Joint Committee on Cancer (AJCC) stages I -III rectal cancer and (b) underwent radical surgery were recruited. In contrast, the exclusion criteria were as follows: (a) other malignancies, (b) received treatment with endoscopic submucosal dissection (ESD), (c) metastatic lesions, (d) did not undergo lymph node dissection, (e) had unavailable assessed lymph node status, and (f) received neoadjuvant therapy. The lymph node metastasis (LNM) status was determined based on the pathological diagnosis of the surgical specimens.
Clinicopathological features included sex, age, body mass index (BMI), comorbidity, distance from the lower edge of the tumor to the anus, carcinoembryonic antigen (CEA) levels, carbohydrate antigen 19-9 (CA19-9) levels, tumor size, degree of tumor differentiation, tumor histology, vascular or lymphatic vessel invasion, AJCC T stage, clinical diagnosis of LNM, and the pathological diagnosis of LNM. Among these, sex, age, BMI, and comorbidities of each participant, such as diabetes, hypertension, hyperlipidemia, and other chronic systemic diseases, were extracted from the electronic hospital information system. Preoperative CEA and CA19-9 levels were obtained from hematological examinations at the time of rectal cancer diagnosis. The distance from the lower edge of the tumor to the anus, differentiation degree, and tumor histology were recorded based on the results of endoscopy and endoscopic biopsies. The tumor diameter and clinical diagnosis of LNM were defined using preoperative pelvic MRI or CT. The diagnosis of vascular invasion, lymphatic vessel invasion, and LNM was based on postoperative pathological diagnosis.
- Conditions
- Rectum Cancer
- Being tested
- The hospital where the treatment is performed
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The hospital where the treatment is performedOther
| Study group | Role | What they receive |
|---|---|---|
| development set; | RC patients from the Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College Receives: Other: The hospital where the treatment is performed | |
| external validation sets 1 | RC patients from Changhai Hospital, Naval Medical University Receives: Other: The hospital where the treatment is performed | |
| external validation sets 2 | RC patients from the Second Affiliated Hospital of Harbin Medical University Receives: Other: The hospital where the treatment is performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis of lymph node metastasis
The lymph node metastasis (LNM) status was determined based on the pathological diagnosis of the surgical specimens.
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start1 Jan 2010
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectum 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
- 6,578 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Harbin Medical University, Changhai Hospital
- Responsible party
- Principal investigator, Xishan Wang, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493930
- Sponsor's protocol ID
- XWang
- Status last verified
- Aug 2022
- First submitted
- 5 Aug 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guan X, Yu G, Zhang W, Wen R, Wei R, Jiao S, Zhao Q, Lou Z, Hao L, Liu E, Gao X, Wang G, Zhang W, Wang X. An easy-to-use artificial intelligence preoperative lymph node metastasis predictor (LN-MASTER) in rectal cancer based on a privacy-preserving computing platform: multicenter retrospective cohort study. Int J Surg. 2023 Mar 1;109(3):255-265. doi: 10.1097/JS9.0000000000000067.
PubMed 36927812
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Easy-to-use Artificial Intelligence Preoperative Lymph Node Metastasis Predictor (LN-MASTER) in Rectal Cancer Based on a Privacy-preserving Computing Platform: Multicenter Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05493930
- Acronym / sponsor ID
- XWang
- Conditions
- Rectum Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,578 participants (actual)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Harbin Medical University, Changhai Hospital
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 9 Aug 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.
In this study, we aim to develop and validate an easy-to-use machine learning prediction model to preoperatively identify the lymph node metastasis status for rectal cancer patients by using these clinical data from three hospitals.
Detailed description
In this study, participants were recruited from the Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College (development set), Changhai Hospital, Naval Medical University (external validation set 1), and the Second Affiliated Hospital of Harbin Medical University (external validation set 2), between January 1, 2016, and December 31, 2020. According to the inclusion criteria, participants who (a) were in American Joint Committee on Cancer (AJCC) stages I -III rectal cancer and (b) underwent radical surgery were recruited. In contrast, the exclusion criteria were as follows: (a) other malignancies, (b) received treatment with endoscopic submucosal dissection (ESD), (c) metastatic lesions, (d) did not undergo lymph node dissection, (e) had unavailable assessed lymph node status, and (f) received neoadjuvant therapy. The lymph node metastasis (LNM) status was determined based on the pathological diagnosis of the surgical specimens.
Clinicopathological features included sex, age, body mass index (BMI), comorbidity, distance from the lower edge of the tumor to the anus, carcinoembryonic antigen (CEA) levels, carbohydrate antigen 19-9 (CA19-9) levels, tumor size, degree of tumor differentiation, tumor histology, vascular or lymphatic vessel invasion, AJCC T stage, clinical diagnosis of LNM, and the pathological diagnosis of LNM. Among these, sex, age, BMI, and comorbidities of each participant, such as diabetes, hypertension, hyperlipidemia, and other chronic systemic diseases, were extracted from the electronic hospital information system. Preoperative CEA and CA19-9 levels were obtained from hematological examinations at the time of rectal cancer diagnosis. The distance from the lower edge of the tumor to the anus, differentiation degree, and tumor histology were recorded based on the results of endoscopy and endoscopic biopsies. The tumor diameter and clinical diagnosis of LNM were defined using preoperative pelvic MRI or CT. The diagnosis of vascular invasion, lymphatic vessel invasion, and LNM was based on postoperative pathological diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| development set; | – | Other: The hospital where the treatment is performedRC patients from the Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College |
| external validation sets 1 | – | Other: The hospital where the treatment is performedRC patients from Changhai Hospital, Naval Medical University |
| external validation sets 2 | – | Other: The hospital where the treatment is performedRC patients from the Second Affiliated Hospital of Harbin Medical University |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- rectal cancer patients with/without lymph node metastasis
Key inclusion criteria (2 listed)
- American Joint Committee on Cancer (AJCC) stages I -III rectal cancer
- underwent radical surgery
Key exclusion criteria (6 listed)
- other malignancies
- received treatment with endoscopic submucosal dissection (ESD)
- metastatic lesions
- did not undergo lymph node dissection
- had unavailable assessed lymph node status
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 |
|---|---|---|
| The hospital where the treatment is performed | Other | development set;, external validation sets 1, external validation sets 2 |
Primary outcome
diagnosis of lymph node metastasis
Time frame: through study completion, an average of 1 month
The lymph node metastasis (LNM) status was determined based on the pathological diagnosis of the surgical specimens.
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 9 Aug 2022.
- Derived from this study: PubMed 36927812Guan X, Yu G, Zhang W, Wen R, Wei R, Jiao S, Zhao Q, Lou Z, Hao L, Liu E, Gao X, Wang G, Zhang W, Wang X. An easy-to-use artificial intelligence preoperative lymph node metastasis predictor (LN-MASTER) in rectal cancer based on a privacy-preserving computing platform: multicenter retrospective cohort study. Int J Surg. 2023 Mar 1;109(3):255-265. doi: 10.1097/JS9.0000000000000067.
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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 Rectum Cancer, run by Peking Union Medical College.
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 2 inclusion and 6 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 9 Aug 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?
diagnosis of lymph node metastasis (time frame: through study completion, an average of 1 month). 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 NCT05493930, which also lists 1 linked publication.
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 9 Aug 2022.