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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03435536
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Tracking Information
First Submitted Date  ICMJE February 2, 2018
First Posted Date  ICMJE February 19, 2018
Last Update Posted Date April 4, 2019
Actual Study Start Date  ICMJE February 26, 2018
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2018)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Surgery Impact on Circulating Tumor DNA in Pancreatic Cancer
Official Title  ICMJE Influence of Pancreatic Adenocarcinoma Excision Surgery on Peripheral and Portal Circulating Tumor DNA: Prospective Exploratory Pilot Study.
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.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Resectable Pancreatic Cancer
Intervention  ICMJE Other: Blood samples
Blood samples will be taken to analyze the circulating tumor DNA rate by NGS
Study Arms  ICMJE Experimental: Circulating tumor DNA
circulating tumor DNA rate at various times of pancreatic cancer resection
Intervention: Other: Blood samples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 14, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Emmanuel CUELLAR, MD 05 61 32 39 83 ext 33 cuellar.e@chu-toulouse.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03435536
Other Study ID Numbers  ICMJE RC31/17/0327
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emmanuel CUELLAR, MD University Hospital, Toulouse
PRS Account University Hospital, Toulouse
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP