MedTrace Logo

Feasibility of Molecular Biology in Pancreatic Cyst Tumors

NCT03305146 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2022-04-14

No results posted yet for this study

Summary

The main objective of the study is to compare the diagnostic accuracy of intra-cystic fluid DNA molecular analysis to standard diagnostics.

The secondary objective of the study is to evaluate the feasibility of intra-cystic fluid DNA molecular analysis.

Conditions

  • Pancreatic Cyst
  • Pancreas Cyst
  • Serous Cystadenoma
  • Mucinous Cystadenoma
  • IPMN

Interventions

GENETIC

Molecular biology analysis of pancreatic intra-cyst fluid

The EUS FNA will be performed according to the Francophone Club of Echo Endoscopy recommendations. For molecular biology technique, the samples will be processed within the UMR\_S910 unit. Nucleic acids will be extracted from the intra-cystic fluid or, for post-operative patients, from a resected specimen that will be collected into a tube containing a nucleic acid stabilization solution (Allprotect Tissue reagent, Qiagen). The nucleic acids will be extracted and then sequenced. The sequencing technology chosen (HaloPlexHS, Agilent) allows a detection close to 1% in allelic frequency. This new technical approach that links high sensitivity and specificity is also suitable with degraded and/or low-volume ( \<50ng) DNA.

Sponsors & Collaborators

  • Ramsay Générale de Santé

    collaborator OTHER

  • Hospital St. Joseph, Marseille, France

    lead OTHER

Principal Investigators

  • Arthur Laquière, MD · French Society of Digestive Endoscopy

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-12-31
Completion
2027-01-31

Countries

  • France

Study Locations

More Related Trials

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 NCT03305146 on ClinicalTrials.gov