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Trial record 59 of 2836 for:    Pancreatic Cancer

Mutation of K-RAS, CDKN2A, SMAD4 and TP53 in Pancreatic Cancer: Role of Liquid Biopsy in Preoperative Diagnosis

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ClinicalTrials.gov Identifier: NCT03524677
Recruitment Status : Recruiting
First Posted : May 15, 2018
Last Update Posted : January 25, 2019
Sponsor:
Collaborator:
Azienda Ospedaliero, Universitaria Pisana
Information provided by (Responsible Party):
Laura Antolino, University of Roma La Sapienza

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.


Condition or disease Intervention/treatment
Pancreatic Cancer Diagnostic Test: Liquid Biopsy

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mutation of K-RAS, CDKN2A, SMAD4 and TP53 in Pancreatic Cancer: Role of Liquid Biopsy in Preoperative Diagnosis
Actual Study Start Date : January 23, 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Non metastatic pancreatic cancer
patients with biopsy or fnac proven ductal adenocarcinoma without any systemic metastatic spread at preoperative imaging
Diagnostic Test: Liquid Biopsy
K-RAS, CDKN2A, SMAD4 and TP53 mutation on circulating cfDNA




Primary Outcome Measures :
  1. Vascular Invasion [ Time Frame: within one month from recruiting ]
    Presence of venous and/or arterial invasion

  2. Early recurrence [ Time Frame: within 12 months from resection ]
    local or systemic recurrence after resection


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 3 years follow up ]
    Time to death

  2. Disease free survival [ Time Frame: 3 years follow up ]
    Time to relapse

  3. N stage [ Time Frame: within one month from recruiting ]
    Presence of locoregional nodes' metastasis


Biospecimen Retention:   Samples With DNA
blood sample


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients affected by non metastatic Pancreatic Cancer
Criteria

Inclusion Criteria:

  • Non metastatic Pancreatic Cancer

Exclusion Criteria:

  • <18y

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524677


Contacts
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Contact: Laura Antolino, MD, PhD stud +393470409876 laura.antolino@uniroma1.it
Contact: Francesco D'Angelo, MD, PhD +390633775632 francesco.dangelo@uniroma1.it

Locations
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Ireland
St Vincent university Hospital Not yet recruiting
Dublin, Ireland
Contact: Andrea Kazemi Nava, MD       andreakazeminava@gmail.com   
Italy
Policlinico Universitario Agostino Gemelli Recruiting
Roma, Italy, 00168
Contact: Giuseppe Bianco, MD       bianco.g@live.com   
AOU Sant'Andrea - UOC Chirurgia Generale Recruiting
Roma, Italy, 00189
Contact: Francesco D'Angelo, MD, PhD    +390633775632    francesco.dangelo@uniroma1.it   
Contact: Laura Antolino, MD    +390633775634    laura.antolino@uniroma1.it   
Sponsors and Collaborators
University of Roma La Sapienza
Azienda Ospedaliero, Universitaria Pisana
Investigators
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Study Chair: Giovanni Ramacciato, MD, FACS Sapieza University of Rome (IT)

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Responsible Party: Laura Antolino, PhD, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT03524677     History of Changes
Other Study ID Numbers: 17_D'Angelo
First Posted: May 15, 2018    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Laura Antolino, University of Roma La Sapienza:
pancreatic cancer
liquid biopsy
vascular invasion
early recurrence

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases