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
About this trial
This is an interventional diagnostic trial for Pancreatic Cancer
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
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
NCT ID
NCT04560270
First Posted
September 5, 2020
Last Updated
September 17, 2020
Sponsor
Poitiers University Hospital
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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