Rectal CancerNCT04635488
Prediction Model for Lateral Lymph Node Metastasis
An observational study of Rectal Cancer, run by West China Hospital at 1 site in China.
Trial summary
Mid to low-lying rectal cancer patient with enlarged lateral lymph node befor treatment and receiving lateral lymph node dissection would be enrolled. Radiomics parameters of lateral lymph nodes would be extracted by expert software. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- lateral lymph node dissection
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with rectal cancer.
Who may be able to join
- middle to low-lying rectal adenocarcinoma patients with enlarged lateral lymph node ≥5mm for short diameter in CT and/or MRI
Who cannot join
- other kind of rectal tumor including neuroendocrine and malignant.
- high location rectal cancer.
- recurrent rectal cancer
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guoxue Road 37#,West China Hospital
Chengdu, Sichuan, 610041
Ziqiang Wang, MD, 18980602028, wangziqiang@scu.edu.cn
About this study
Official title: Radiomics-based Prediction Model for Lateral Lymph Node Metastasis in Rectal Cancer
Mid to low-lying rectal cancer patient with enlarged lateral lymph node befor treatment and receiving lateral lymph node dissection would be enrolled. Radiomics parameters of lateral lymph nodes would be extracted by expert software. Then a part of the nodes would be used as the training set to build the prediction model, and the another part nodes would be used as the validation set.
Read the detailed description
After performing lateral lymph node dissection for the enrolled patients, we would find the targeted lateral node which was matched with the enlarged one in imaging from the specimen. Then the nodes would be send for pathological examination. Then we would extract the radiomics parameters of the nodes from the pretreatment CT and MRI with ITK-SNAP software. According to the pathological status, lymph nodes and corresponding radiomics parameters would be divided into positive and negative groups. Then significant parameters would be selected by R software. Then the prediction model with nomogram would be developed. 70% nodes would be used for for model development and the other 30% would be used for validation.
- Conditions
- Rectal Cancer
- Being tested
- lateral lymph node dissection
- Keywords
- rectal cancer, lymph node metastasis, prediction model
- Medical subject headings
- Rectal Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lateral lymph node dissectionProcedure or surgery
All participted would receive lateral lymph node dissection for rectal cancer.
| Study group | Role | What they receive |
|---|---|---|
| Trainning group | 70% of the whole participants would be randomly divided into the training group to build the predicition model. Receives: Procedure: lateral lymph node dissection | |
| validation group | 30% of the whole participant would be divided into the validation group to validate the model Receives: Procedure: lateral lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
metastasis rate of lateral lymph node
Measured: 2020.1-2022.12.31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start1 Jan 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziqiang Wang,MD, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635488
- Sponsor's protocol ID
- LLNM-2020
- Status last verified
- Nov 2020
- First submitted
- 13 Nov 2020
- Last updated
- 19 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data (IPD) would not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiomics-based Prediction Model for Lateral Lymph Node Metastasis in Rectal Cancer
- ClinicalTrials.gov ID
- NCT04635488
- Acronym / sponsor ID
- LLNM-2020
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, lymph node metastasis, prediction model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 Nov 2020 (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.
Mid to low-lying rectal cancer patient with enlarged lateral lymph node befor treatment and receiving lateral lymph node dissection would be enrolled. Radiomics parameters of lateral lymph nodes would be extracted by expert software. Then a part of the nodes would be used as the training set to build the prediction model, and the another part nodes would be used as the validation set.
Detailed description
After performing lateral lymph node dissection for the enrolled patients, we would find the targeted lateral node which was matched with the enlarged one in imaging from the specimen. Then the nodes would be send for pathological examination. Then we would extract the radiomics parameters of the nodes from the pretreatment CT and MRI with ITK-SNAP software. According to the pathological status, lymph nodes and corresponding radiomics parameters would be divided into positive and negative groups. Then significant parameters would be selected by R software. Then the prediction model with nomogram would be developed. 70% nodes would be used for for model development and the other 30% would be used for validation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trainning group | – | Procedure: lateral lymph node dissection70% of the whole participants would be randomly divided into the training group to build the predicition model. |
| validation group | – | Procedure: lateral lymph node dissection30% of the whole participant would be divided into the validation group to validate the model |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with rectal cancer.
Key inclusion criteria (1 listed)
- middle to low-lying rectal adenocarcinoma patients with enlarged lateral lymph node ≥5mm for short diameter in CT and/or MRI
Key exclusion criteria (3 listed)
- other kind of rectal tumor including neuroendocrine and malignant.
- high location rectal cancer.
- recurrent rectal cancer
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 |
|---|---|---|
| lateral lymph node dissectionAll participted would receive lateral lymph node dissection for rectal cancer. | Procedure or surgery | Trainning group, validation group |
Primary outcome
metastasis rate of lateral lymph node
Time frame: 2020.1-2022.12.31
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Individual participant dataSharing planned: No. individual participant data (IPD) would not be available to other researchers.
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Toripalimab Plus Cetuximab and Irinotecan for Second-Line Right-Sided RAS/BRAF Wild-Type Advanced Colon Cancer Phase II Study
Colorectal Cancer (CRC)
Not yet recruiting
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
Rectal Cancer Patients, Rectal Cancer Surgery
Not yet recruiting
A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced / Metastatic Solid Tumors.
NSCLC (Advanced Non-small Cell Lung Cancer), NSCLC (Non-small Cell Lung Cancer)
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
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.
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 Rectal Cancer, run by West China Hospital 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ziqiang Wang, MD (18980602028, wangziqiang@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
metastasis rate of lateral lymph node (time frame: 2020.1-2022.12.31). 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 19 Nov 2020.