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Completed

NCT Number: NCT04560270

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood samples

Diagnostic Test

Blood samples to determine ctDNA levels during chemotherapy

Primary outcomes

  1. Correlation of the ctDNA level to the response to chemotherapy

    Time frame: 3 months

    Response to chemotherapy was evaluated with RECIST criteria 1.1 on the first CT scan

Secondary outcomes

  1. Overall survival

    Time frame: 6 months after last patients inclusion

    Correlation between variation of ctDNA and overall survival

  2. Progression free survival

    Time frame: 6 months after last patients inclusion

    Correlation between variation of ctDNA and progression free survival

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

KRAS (Kirsten Rat Sarcoma) Mutant CIrculating Tumor DNA for Monitoring Response to First Line Chemotherapy in Locally Advanced and Metastatic PANcreatic Cancer

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 23, 2020
Registry last updated
Sep 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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