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

NCT03524677 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2019-01-25

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Liquid Biopsy

K-RAS, CDKN2A, SMAD4 and TP53 mutation on circulating cfDNA

Sponsors & Collaborators

  • Azienda Ospedaliero, Universitaria Pisana

    collaborator OTHER

  • University of Roma La Sapienza

    lead OTHER

Principal Investigators

  • Giovanni Ramacciato, MD, FACS · Sapieza University of Rome (IT)

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-23
Primary Completion
2019-11-30
Completion
2020-01-31

Countries

  • Ireland
  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03524677 on ClinicalTrials.gov