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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Only arm | Experimental | Blood samples to analyze ctDNA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples | Diagnostic Test | Blood samples to determine ctDNA levels during chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Correlation between variation of ctDNA and overall survival | 6 months after last patients inclusion |
| Progression free survival | Correlation between variation of ctDNA and progression free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37308396 | Derived | Evrard C, Ingrand P, Rochelle T, Martel M, Tachon G, Flores N, Randrian V, Ferru A, Haineaux PA, Goujon JM, Karayan-Tapon L, Tougeron D. Circulating tumor DNA in unresectable pancreatic cancer is a strong predictor of first-line treatment efficacy: The KRASCIPANC prospective study. Dig Liver Dis. 2023 Nov;55(11):1562-1572. doi: 10.1016/j.dld.2023.03.011. Epub 2023 Jun 10. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 6 months after last patients inclusion |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |