Predictive Cancer ModelNCT05997147
A Preoperative Model to Predict the Lymphovascular Invasion in Pancreatic Ductal Adenocarcinoma
An observational study of Predictive Cancer Model and Pancreas Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Importance: Lymphovascular invasion (LVI) is a poor prognosis pathologic feature in pancreatic ductal adenocarcinoma (PDAC) patients. Neoadjuvant therapy may bring survival benefits to these patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Predictive Cancer Model, Pancreas Cancer
- How many people
- 1,009 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 30 Aug 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were pathologically diagnosed as PDAC and received curative surgery.
Who may be able to join
- Patients who were pathologically diagnosed as PDAC and received curative surgery.
Who cannot join
- Patients with distant metastasis; Patients who received neoadjuvant therapy; Patients with a survival time of less than 1 month.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Jihui Hao, Dr, +8618622221120
About this study
Official title: Development and Validation of a Preoperative Model to Predict the Lymphovascular Invasion of Pancreatic Ductal Adenocarcinoma: a Multicenter Retrospective Study
Importance: Lymphovascular invasion (LVI) is a poor prognosis pathologic feature in pancreatic ductal adenocarcinoma (PDAC) patients. Neoadjuvant therapy may bring survival benefits to these patients.
Objective: To construct a preoperative model which could predict LVI in PDAC patients and further validate it in other cohorts.
Design, Setting, and Participants: Patients from 3 three tertiary hospitals were included in this study. Univariate and multivariate Logistic regression analyses were conducted to define independent prediction factors of LVI. A nomogram was constructed based on the result of multivariate analysis.The predictive value of the model was assessed using receiver operating characteristic (ROC) curves and the maximum Youden index of the ROC curve was defined as the cut-off point. The calibration plot was utilized to assess the concordance of the model. The decision curve analyses (DCA) were applied to estimate the clinical benefit of using this model to predict LVI.
- Conditions
- Predictive Cancer Model, Pancreas Cancer
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival
Time from operation to the detection of recurrence or last follow-up
Measured: 10 years
Secondary outcomes (1)
Overall survival
Time between surgical resection to death or the last follow-up.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start1 May 2023
- Primary completion5 Aug 2023
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Predictive Cancer ModelStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- Retrospective
- Enrolment
- 1,009 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jihui Hao, Dr, Study chair, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997147
- Sponsor's protocol ID
- Panc-LVI-2023810
- Status last verified
- Aug 2023
- First submitted
- 10 Aug 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Preoperative Model to Predict the Lymphovascular Invasion of Pancreatic Ductal Adenocarcinoma: a Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT05997147
- Acronym / sponsor ID
- Panc-LVI-2023810
- Conditions
- Predictive Cancer Model, Pancreas Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,009 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 5 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 18 Aug 2023 (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.
Importance: Lymphovascular invasion (LVI) is a poor prognosis pathologic feature in pancreatic ductal adenocarcinoma (PDAC) patients. Neoadjuvant therapy may bring survival benefits to these patients.
Objective: To construct a preoperative model which could predict LVI in PDAC patients and further validate it in other cohorts.
Design, Setting, and Participants: Patients from 3 three tertiary hospitals were included in this study. Univariate and multivariate Logistic regression analyses were conducted to define independent prediction factors of LVI. A nomogram was constructed based on the result of multivariate analysis.The predictive value of the model was assessed using receiver operating characteristic (ROC) curves and the maximum Youden index of the ROC curve was defined as the cut-off point. The calibration plot was utilized to assess the concordance of the model. The decision curve analyses (DCA) were applied to estimate the clinical benefit of using this model to predict LVI.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were pathologically diagnosed as PDAC and received curative surgery.
Key inclusion criteria (1 listed)
- Patients who were pathologically diagnosed as PDAC and received curative surgery.
Key exclusion criteria (1 listed)
- Patients with distant metastasis; Patients who received neoadjuvant therapy; Patients with a survival time of less than 1 month.
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
Recurrence-free survival
Time frame: 10 years
Time from operation to the detection of recurrence or last follow-up
1 secondary outcome
Overall survival
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 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.
Jihui Hao, Dr study chair
Tianjin Medical University Cancer Institute and Hospital
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 Predictive Cancer Model and Pancreas Cancer, run by Tianjin Medical University Cancer Institute and 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 18 Aug 2023. 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 Jihui Hao, Dr (+8618622221120, haojihui@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (time frame: 10 years). 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 18 Aug 2023.