Multicentric Database for KRAS Mutant Pancreatic Cancer
Construction and Maintenance of a Precision Subtyping-Based Clinical Cohort for Targeted Therapy in KRAS-Mutant Pancreatic Cancer
Study Overview
Status
Conditions
Detailed Description
Pancreatic cancer is one of the most aggressive tumors in the digestive system, often referred to as the "king of cancers". Globally, its incidence and mortality rank 12th and 7th among all malignant tumors. According to the American Cancer Society, pancreatic cancer is projected to become the second leading cause of cancer-related death in the US by 2030.
KRAS gene mutations are the most common genetic alterations in pancreatic cancer, occurring in approximately 90% of patients, with subtypes such as G12D, G12V, and G12R being particularly prevalent. Conventional chemotherapy and radiotherapy offer limited efficacy and are associated with significant side effects.
With advances in precision medicine, targeted therapy has emerged as a promising treatment strategy. Substantial progress has been made in developing KRAS-targeted drugs, some of which have entered clinical trials and shown encouraging results. However, due to the complexity and heterogeneity of KRAS mutations, patient responses to targeted therapy vary significantly. Therefore, it is essential to establish a prospective cohort study to comprehensively evaluate the efficacy and safety of KRAS-targeted therapies and inform clinical decision-making.
We aim to construct a clinical cohort for KRAS-mutant pancreatic cancer patients undergoing targeted therapy, with the goal of building a database system aligned with both clinical practice and research needs. This study consists of two components:
- Designing and implementing a database tailored to real-world clinical scenarios, retrospectively collecting clinical data from pancreatic tumor patients treated at the Shanghai Pancreatic Cancer Institute and multiple domestic and international centers, thereby establishing a real-world evidence (RWE) database;
- Prospectively collecting clinical information from pancreatic cancer patients treated at the same institutions, with regular updates and maintenance of the pancreatic tumor RWE database.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yi Liu, MD
- Phone Number: 86 21-64175590
- Email: liuyi@fudanpci.org
Study Locations
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Shanghai, China, 200032
- Recruiting
- Department of Pancreatic Surgery
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
This study is a multicenter real-world data collection research . It aims to establish a multicenter real-world evidence (RWE) database for KRAS-targeted therapy in pancreatic cancer. The study will retrospectively collect clinical data of pancreatic cancer patients with KRAS mutations previously diagnosed and treated at the Shanghai Pancreatic Cancer Institute , and prospectively collect clinical information from similar patients treated at the same institute. The database will be regularly updated and maintained.
Clinical data of KRAS-mutant pancreatic cancer patients from domestic and international pancreatic tumor centers will be collected and periodically updated. Identifiable personal information such as ID numbers and names will be removed to enable multicenter collaboration and ensure patient privacy, with the goal of generating reliable evidence-based medical data .
Description
Inclusion Criteria:
No restrictions on age, gender, or performance status score;
Pathologically or cytologically confirmed pancreatic adenocarcinoma; ③ Known KRAS mutation subtype and has received treatment with KRAS-targeted agents;
④ Able to comply with the study visit schedule requirements;
⑤ Voluntarily participate and sign the informed consent form.
Exclusion Criteria:
Non-neoplastic pancreatic lesions;
- Non-primary pancreatic neoplastic lesions; ③ Unable to comply with the study visit schedule requirements; ④ Refuse to participate and sign the informed consent form.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Pancreatic cancer with KRAS mutation
Patients with pancreatic cancer with KRAS mutation who received KRAS targeted therapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Overall survival
Time Frame: 12 months
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OS: OS of subjects from recruiting to the time of death from any cause
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Progression free survival (PFS)
Time Frame: up to 10 years
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Progression free survival (PFS) is calculated from the date of starting KRAS targted therapy and ends when the first event (progression/death) occurs.
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up to 10 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Guopei Luo, Fudan University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PTCA199-17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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