Pancreatic CancerNCT05313854
Diagnosis and Survival Prediction of Pancreatic Cancer by Machine Learning of Image Data
An observational study of Pancreatic Cancer, run by RenJi Hospital at 1 site in China.
Trial summary
This prospective cohort study is designed to investigate the diagnostic ability and prediction accuracy of pancreatic cancer by radiomics data and clinical data. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2023
- 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: hospitalized patients with radiology conformed pancreatic tumor
Who may be able to join
- Clinical diagnosis of pancreatic tumor; Must have CT / MRI / ultrasound data and pathology diagnosis
Who cannot join
- Have other tumors along with pancreatic tumor; Clinical information missing
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai
Tao Chen, MD., dr_chentao78@163.com
About this study
This prospective cohort study is designed to investigate the diagnostic ability and prediction accuracy of pancreatic cancer by radiomics data and clinical data.
Read the detailed description
In this study, investigators aimed to investigate the diagnostic performance and prediction accuracy of pancreatic cancer by radiomics data and clinical data, which include CT scan, MRI, PET-CT, PET-MR, ultrasound, and clinical data.
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Machine Learning, Radiomics, CT, MRI, Ultrasound
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient overall survival
Patient overall survival, from the time of diagnosis of pancreatic tumor to the death of the patient.
Measured: up to 3 years
Secondary outcomes (1)
Pathology diagnosis
Pathology diagnosis of the patient, such as adenocarcinoma, pancreatic neuroendocrine tumors, intraductal Papillary Mucinous Neoplasm, et al.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 Jan 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
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 Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by RenJi 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Chen, Dr, Principal investigator, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313854
- Sponsor's protocol ID
- RA-2020-455
- Status last verified
- Mar 2022
- First submitted
- 16 Mar 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xu X, Qu J, Zhang Y, Qian X, Chen T, Liu Y. Development and validation of an MRI-radiomics nomogram for the prognosis of pancreatic ductal adenocarcinoma. Front Oncol. 2023 Feb 24;13:1074445. doi: 10.3389/fonc.2023.1074445. eCollection 2023.
PubMed 36910599
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Survival Prediction of Pancreatic Cancer by Machine Learning of Image Data
- ClinicalTrials.gov ID
- NCT05313854
- Acronym / sponsor ID
- RA-2020-455
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Machine Learning, Radiomics, CT, MRI, Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 Apr 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.
This prospective cohort study is designed to investigate the diagnostic ability and prediction accuracy of pancreatic cancer by radiomics data and clinical data.
Detailed description
In this study, investigators aimed to investigate the diagnostic performance and prediction accuracy of pancreatic cancer by radiomics data and clinical data, which include CT scan, MRI, PET-CT, PET-MR, ultrasound, and clinical data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- hospitalized patients with radiology conformed pancreatic tumor
Key inclusion criteria (1 listed)
- Clinical diagnosis of pancreatic tumor; Must have CT / MRI / ultrasound data and pathology diagnosis
Key exclusion criteria (1 listed)
- Have other tumors along with pancreatic tumor; Clinical information missing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient overall survival
Time frame: up to 3 years
Patient overall survival, from the time of diagnosis of pancreatic tumor to the death of the patient.
1 secondary outcome
Pathology diagnosis
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Derived from this study: PubMed 36910599Xu X, Qu J, Zhang Y, Qian X, Chen T, Liu Y. Development and validation of an MRI-radiomics nomogram for the prognosis of pancreatic ductal adenocarcinoma. Front Oncol. 2023 Feb 24;13:1074445. doi: 10.3389/fonc.2023.1074445. eCollection 2023.
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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.
Tao Chen, Dr principal investigator
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
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 Pancreatic Cancer, run by RenJi 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 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: status not confirmed, as of the sponsor's last update on 6 Apr 2022. 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 Xinsen Xu, Dr (+86-21-68383713, xuxinsen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient overall survival (time frame: up to 3 years). 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 NCT05313854, 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 6 Apr 2022.