Pancreatic Ductal AdenocarcinomaNCT04954378
Radiomics Based on Multimodal Imaging in Predicting Staging and Prognosis of Pancreatic Cancer
An observational study of Pancreatic Ductal Adenocarcinoma, run by Peking University Third Hospital.
Trial summary
Retrospectively analyzed radiomics features of pancreatic ductal adenocarcinoma to predict staging and prognosis Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- radiomics
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 30 Dec 2020
- 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: Pancreatic tumor patients
Who may be able to join
- radical resection was performed, and histopathologically confirmed pancreatic ductal adenocarcinoma and lymph node status;2) CT and/or MRI enhancement examinations were performed 2 weeks before surgery;3) Patients with complete clinical data
Who cannot join
- (1)Patients who received radiotherapy or chemotherapy before preoperative imaging examination;2) Poor image quality.
About this study
Retrospectively analyzed radiomics features of pancreatic ductal adenocarcinoma to predict staging and prognosis
Read the detailed description
Pancreatic cancer is the most malignant tumor of the digestive system and the seventh leading cause of cancer-related death worldwide.The rate of lymph node metastasis in pancreatic cancer is as high as 59%.Lymph node metastasis is an important prognostic factor, which is closely associated with poor prognosis of pancreatic cancer patients.Preoperative accurate prediction of lymph node status has important clinical value.At present, the preoperative LN status of pancreatic cancer patients is mainly evaluated by conventional imaging methods such as CT and MRI.The accuracy of evaluating LN state only from the perspective of morphology is poor.Ductal adenocarcinoma of the pancreas is highly malignant, has a median disease-free survival of only about 1 year, and most pancreatic cancer patients eventually relapse.At present, TNM staging system is mainly used for prognosis evaluation.However, even among patients with the same TNM stage, the prognosis is still significantly different, which reflects the lack of prognostic information provided by the TNM stage.Imaging omics extracts a large number of quantitative features from medical images in a high-throughput manner to enable non-invasive analysis of intra-tumor heterogeneity.In this study, we planned to construct a prediction study of preoperative lymph node metastasis and prognosis of pancreatic cancer based on multimodal imaging, so as to provide a basis for clinical treatment decision and prognosis.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- radiomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiomicsDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Positive lymph node metastasis | pathological diagnosis :Positive lymph node metastasis Receives: Diagnostic Test: radiomics | |
| Negative lymph node metastasis | pathological diagnosis :Negative lymph node metastasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiomics features
1409 radiomics features can be extracted from the images.
Measured: After sketching the ROI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Jan 2010
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huishu Yuan, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954378
- Sponsor's protocol ID
- M2021060
- Status last verified
- Jun 2021
- First submitted
- 29 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiomics Based on Multimodal Imaging in Predicting Staging and Prognosis of Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04954378
- Acronym / sponsor ID
- M2021060
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 8 Jul 2021 (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.
Retrospectively analyzed radiomics features of pancreatic ductal adenocarcinoma to predict staging and prognosis
Detailed description
Pancreatic cancer is the most malignant tumor of the digestive system and the seventh leading cause of cancer-related death worldwide.The rate of lymph node metastasis in pancreatic cancer is as high as 59%.Lymph node metastasis is an important prognostic factor, which is closely associated with poor prognosis of pancreatic cancer patients.Preoperative accurate prediction of lymph node status has important clinical value.At present, the preoperative LN status of pancreatic cancer patients is mainly evaluated by conventional imaging methods such as CT and MRI.The accuracy of evaluating LN state only from the perspective of morphology is poor.Ductal adenocarcinoma of the pancreas is highly malignant, has a median disease-free survival of only about 1 year, and most pancreatic cancer patients eventually relapse.At present, TNM staging system is mainly used for prognosis evaluation.However, even among patients with the same TNM stage, the prognosis is still significantly different, which reflects the lack of prognostic information provided by the TNM stage.Imaging omics extracts a large number of quantitative features from medical images in a high-throughput manner to enable non-invasive analysis of intra-tumor heterogeneity.In this study, we planned to construct a prediction study of preoperative lymph node metastasis and prognosis of pancreatic cancer based on multimodal imaging, so as to provide a basis for clinical treatment decision and prognosis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive lymph node metastasis | – | Diagnostic Test: radiomicspathological diagnosis :Positive lymph node metastasis |
| Negative lymph node metastasis | – | –pathological diagnosis :Negative lymph node metastasis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pancreatic tumor patients
Key inclusion criteria (1 listed)
- radical resection was performed, and histopathologically confirmed pancreatic ductal adenocarcinoma and lymph node status;2) CT and/or MRI enhancement examinations were performed 2 weeks before surgery;3) Patients with complete clinical data
Key exclusion criteria (1 listed)
- (1)Patients who received radiotherapy or chemotherapy before preoperative imaging examination;2) Poor image quality.
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 |
|---|---|---|
| radiomics | Diagnostic test | Positive lymph node metastasis |
Primary outcome
radiomics features
Time frame: After sketching the ROI
1409 radiomics features can be extracted from the images.
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 8 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Huishu Yuan study chair
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Ductal Adenocarcinoma, run by Peking University Third Hospital.
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 8 Jul 2021. 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?
radiomics features (time frame: After sketching the ROI). 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 8 Jul 2021.