Mutation of K-RAS, CDKN2A, SMAD4 and TP53 in Pancreatic Cancer: Role of Liquid Biopsy in Preoperative Diagnosis
1 other identifier
observational
50
2 countries
3
Brief Summary
Pancreatic cancers represent a challenge for the multidisciplinal team. A patient-tailored treatment plan requires an accurate preoperative staging. Currently more than 40% of patient taken to the OR are actually unresectable and another 40% will shortly recur with dismal prognosis. Among patients that meet upfront surgery some would have benefit of a neoadjuvant treatment and vice versa. Accuracy of preoperative staging is of primary importance in treatment decisional making. Due to its location, invasive preoperative diagnostic tests on pancreatic cancer are expensive and risky. Liquid biopsy provides a non-invasive signature of the tumor. Analyzing mutations on cell-free nucleic acids gives translational information on tumor biology and therefore on its clinic-pathological features and likely on its progression. This study would be the first -in our knowledge- analyzing the relationship of a pattern of 4 major genes involved in pancreatic cancer progression on liquid biopsy and the time to recurrence and T-stage, with particular attention to vascular invasion. A properly staged patient provides a better resource allocation, an optimal treatment plan and improves patient's outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2019
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2018
CompletedFirst Posted
Study publicly available on registry
May 15, 2018
CompletedStudy Start
First participant enrolled
January 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedJanuary 25, 2019
January 1, 2019
9 months
May 2, 2018
January 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Vascular Invasion
Presence of venous and/or arterial invasion
within one month from recruiting
Early recurrence
local or systemic recurrence after resection
within 12 months from resection
Secondary Outcomes (3)
Overall Survival
3 years follow up
Disease free survival
3 years follow up
N stage
within one month from recruiting
Study Arms (1)
Non metastatic pancreatic cancer
patients with biopsy or fnac proven ductal adenocarcinoma without any systemic metastatic spread at preoperative imaging
Interventions
K-RAS, CDKN2A, SMAD4 and TP53 mutation on circulating cfDNA
Eligibility Criteria
Patients affected by non metastatic Pancreatic Cancer
You may qualify if:
- Non metastatic Pancreatic Cancer
You may not qualify if:
- \<18y
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
St Vincent university Hospital
Dublin, Ireland
Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
AOU Sant'Andrea - UOC Chirurgia Generale
Roma, 00189, Italy
Biospecimen
blood sample
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Giovanni Ramacciato, MD, FACS
Sapieza University of Rome (IT)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
May 2, 2018
First Posted
May 15, 2018
Study Start
January 23, 2019
Primary Completion
November 1, 2019
Study Completion
January 1, 2020
Last Updated
January 25, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share