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CIrculating Tumor DNA for Monitoring Response to First Line Chemotherapy in Unresectable PANcreatic Cancer

Primary Purpose

Pancreatic Cancer, Circulating Tumor DNA, KRAS Mutation-Related Tumors

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blood samples
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Proven pancreatic adenocarcinoma (histology or cytology)
  • Metastatic or locally advanced unresectable
  • With thoraco-abdomino-pelvic scanner less than a month old
  • Chemotherapy treatment regardless of the protocol
  • Patients benefiting from a Social Security scheme or benefiting through the intermediary of a third party
  • Informed consent signed by the patient after clear and fair information about the study

Exclusion Criteria:

  • Linguistic or psychological refusal or inability to understand and / or sign the informed consent
  • History of cancer in the 5 years preceding inclusion
  • Patient who has already received chemotherapy or radiotherapy for pancreatic cancer.
  • Immediately resectable tumor

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Only arm

    Arm Description

    Blood samples to analyze ctDNA

    Outcomes

    Primary Outcome Measures

    Correlation of the ctDNA level to the response to chemotherapy
    Response to chemotherapy was evaluated with RECIST criteria 1.1 on the first CT scan

    Secondary Outcome Measures

    Overall survival
    Correlation between variation of ctDNA and overall survival
    Progression free survival
    Correlation between variation of ctDNA and progression free survival

    Full Information

    First Posted
    September 5, 2020
    Last Updated
    September 17, 2020
    Sponsor
    Poitiers University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04560270
    Brief Title
    CIrculating Tumor DNA for Monitoring Response to First Line Chemotherapy in Unresectable PANcreatic Cancer
    Official Title
    KRAS (Kirsten Rat Sarcoma) Mutant CIrculating Tumor DNA for Monitoring Response to First Line Chemotherapy in Locally Advanced and Metastatic PANcreatic Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 25, 2016 (Actual)
    Primary Completion Date
    June 28, 2019 (Actual)
    Study Completion Date
    November 15, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Poitiers University Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    With an incidence of more than 11,600 new cases per year in France and an annual number of deaths close to the incidence rate, adenocarcinoma of the pancreas is a public health problem. The aim of this study is to assess the predictive value of response to the 1st line of chemotherapy of mutated KRAS ctDNA (circulating tumor DNA) in unresectable metastatic or locally advanced pancreatic adenocarcinomas.
    Detailed Description
    With an incidence of more than 11,600 new cases per year in France and an annual number of deaths close to the incidence rate, adenocarcinoma of the pancreas is a public health problem especially since there is a significant increase in its incidence. incidence (+ 417% between 1980 and 2012). Most often diagnosed late, pancreatic adenocarcinoma is managed at a metastatic stage in 60 to 70% of cases with a very poor prognosis (8.7 to 11.1 months median survival with current chemotherapies). The first line of chemotherapy therefore represents a major issue in the management of these unresectable patients. There are few predictive markers of response to chemotherapy in pancreatic adenocarcinoma. It is conventionally evaluated by scanner every 2 to 3 months. The response to chemotherapy is associated with a good prognosis while non-response has a poor prognosis and requires a 2nd line of treatment if the patient is able to receive it. A KRAS mutation is present in approximately 70-90% of pancreatic adenocarcinomas. Its research on tissue sampling (fine needle aspiration or anatomo-pathological specimen) is not carried out routinely because no prognostic or predictive value of KRAS mutations has been demonstrated. New high-throughput DNA sequencing techniques have been developed and now allow a blood sample to detect and quantify circulating tumor DNA (ctDNA), including KRAS mutations. Very few studies have investigated the change in cDNA levels during 1st line chemotherapy in unresectable pancreatic adenocarcinoma. The aim of this study is to assess the predictive value of response to the 1st line of chemotherapy of mutated KRAS cDNA in unresectable metastatic or locally advanced pancreatic adenocarcinomas.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pancreatic Cancer, Circulating Tumor DNA, KRAS Mutation-Related Tumors

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    69 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Only arm
    Arm Type
    Experimental
    Arm Description
    Blood samples to analyze ctDNA
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Blood samples
    Intervention Description
    Blood samples to determine ctDNA levels during chemotherapy
    Primary Outcome Measure Information:
    Title
    Correlation of the ctDNA level to the response to chemotherapy
    Description
    Response to chemotherapy was evaluated with RECIST criteria 1.1 on the first CT scan
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Overall survival
    Description
    Correlation between variation of ctDNA and overall survival
    Time Frame
    6 months after last patients inclusion
    Title
    Progression free survival
    Description
    Correlation between variation of ctDNA and progression free survival
    Time Frame
    6 months after last patients inclusion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Proven pancreatic adenocarcinoma (histology or cytology) Metastatic or locally advanced unresectable With thoraco-abdomino-pelvic scanner less than a month old Chemotherapy treatment regardless of the protocol Patients benefiting from a Social Security scheme or benefiting through the intermediary of a third party Informed consent signed by the patient after clear and fair information about the study Exclusion Criteria: Linguistic or psychological refusal or inability to understand and / or sign the informed consent History of cancer in the 5 years preceding inclusion Patient who has already received chemotherapy or radiotherapy for pancreatic cancer. Immediately resectable tumor

    12. IPD Sharing Statement

    Learn more about this trial

    CIrculating Tumor DNA for Monitoring Response to First Line Chemotherapy in Unresectable PANcreatic Cancer

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