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Trial record 52 of 2862 for:    Pancreatic Cancer AND pancreas

Surgery Impact on Circulating Tumor DNA in Pancreatic Cancer (ICAPAC)

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ClinicalTrials.gov Identifier: NCT03435536
Recruitment Status : Recruiting
First Posted : February 16, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
Pancreatic cancer represents the fourth cause of death by cancer in western countries. The only curative treatment is surgery but this one is possible only in 10 to 15 % of cases. To date, there are few biomarkers in circulating blood as prognostic or diagnostic markers in pancreatic cancer. The purpose of this study is to determine if the pancreatic tumor mobilization during its resection impacts the quantity of circulating tumor DNA in peripheral and portal blood.

Condition or disease Intervention/treatment Phase
Resectable Pancreatic Cancer Other: Blood samples Not Applicable

Detailed Description:
The investigators will analyze if the tumor mobilization increases circulating DNA rate in peripheral and portal blood. Moreover, circulating tumor DNA will be measured during 12 months after surgery in peripheral blood. They will use a gene mutation detection technique called Next Generation Sequencing (NGS) which is more specific than a simple Polymerase Chain Reaction (PCR).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Influence of Pancreatic Adenocarcinoma Excision Surgery on Peripheral and Portal Circulating Tumor DNA: Prospective Exploratory Pilot Study.
Actual Study Start Date : February 26, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Circulating tumor DNA
circulating tumor DNA rate at various times of pancreatic cancer resection
Other: Blood samples
Blood samples will be taken to analyze the circulating tumor DNA rate by NGS




Primary Outcome Measures :
  1. Kinetic of circulating tumor DNA evaluation in resected pancreatic cancer. [ Time Frame: Kinetic up to one year ]
    To analyse circulating tumor DNA rate in the portal vein and in peripheral blood at various times of pancreatic cancer resection. Kinetic to 1 day before surgery, during surgery and after surgery (1 day, 10days , one month, 3 months, 6 months and one year after surgery)


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Kinetic up to one year ]
    to analyse correlation between circulating tumor DNA rate and overall survival and survival without recurrence. Kinetic to 1 day before surgery, during surgery and after surgery (1 day, one month, 3 months, 6 months and one year after surgery)

  2. Correlation between circulating tumor DNA rate and Ca19.9 dosage [ Time Frame: Kinetic up to one year ]
    to analyse correlation between circulating tumor DNA and Ca19.9 rate after dosage of C19.9. Kinetic to 1 day before surgery, and after surgery (on day, one month, 3 months, 6 months and one year after surgery)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Every patient taken care by Toulouse University Hospital for the resection of a non-metastatic pancreatic adenocarcinoma by whipple resection.
  • Patient aged over 18 years old
  • Patient having given his written consent
  • Patient with social insurance coverage

Exclusion Criteria:

  • Patients who had surgery, but their pathological examination of the resected specimen does not contain adenocarcinoma.
  • Patient for whom the surgery was not realized (exploratory laparotomy)

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): NCT03435536


Contacts
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Contact: Emmanuel CUELLAR, MD 05 61 32 39 83 ext 33 cuellar.e@chu-toulouse.fr

Locations
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France
University Hospital Recruiting
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Emmanuel CUELLAR, MD University Hospital, Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03435536     History of Changes
Other Study ID Numbers: RC31/17/0327
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 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 University Hospital, Toulouse:
circulating tumor DNA
kinetic
pancreatic cancer
pancreatoduodenectomy
Next Generation Sequencing
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