Evaluation of GEMCITEST in Patients With Pancreatic Cancer and Treated by Chemotherapy (GEMCIPANC)
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|ClinicalTrials.gov Identifier: NCT03599154|
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : July 25, 2018
Pancreatic cancer has a 5-year overall survival rate around 5%. It is the 6th most common cancer in France (11 600 new annual cases in 2012) and the 4th leading cause of cancer deaths in France and Europe.
Many translational research has tried to identify biomarkers in pancreatic cancer. Only the expression of hENT1 evaluated on the tumor tissue with the mouse antibody seems really relevant by providing a predictive value of the effectiveness of gemcitabine adjuvant. In a metastatic situation, there is no predictive marker of the effectiveness of chemotherapy treatments.
GemciTest(TM), studied in this study, is developed by the company Acobiom. Test based on the qRT-PCR technology that allows the establishment of a molecular signature of 10 genes that showed its interest as a biomarker in 60 patients with metastatic pancreatic adenocarcinoma treated with gemcitabine. Retrospective analysis differentiated 2 patient populations:
- 22 patients with a "favorable" expression gene with a median survival of 14.9 months
- 35 patients with an "adverse" expression gene with a median survival of 5.1 months
Primary objective: To evaluate in patients with pancreatic cancer, treated with Gemcitabine alone or combined (nab-paclitaxel) or with Folfirinox, the prognostic value of the GemciTest(TM) test on overall survival and response to treatment.
To realize this study, only one 2.5 mL blood sample is taken before starting chemotherapy. The standard practice data is then saved.
100 patients will be included.
|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||Evaluation of GEMCITEST in Patients With Pancreatic Cancer and Treated by Chemotherapy|
|Actual Study Start Date :||January 30, 2018|
|Actual Primary Completion Date :||January 30, 2018|
|Estimated Study Completion Date :||January 30, 2020|
- Overall survival [ Time Frame: average of 1 year ]Overall survival is defined as survival between Day 1 of the first line of chemotherapy and death
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599154
|Contact: François Ghiringhelli, PU PH||03.80.73.75.00||FGhiringhelli@cgfl.fr|
|Contact: Emilie REDERSTORFF||03 45 34 81 firstname.lastname@example.org|
|Centre Georges François Leclerc||Recruiting|
|Dijon, France, 21000|
|Contact: François Ghiringhelli, PU PH 03.80.73.75.00 FGhiringhelli@cgfl.fr|
|Study Director:||François Ghiringhelli, PU PH||Centre Georges François Leclerc, DIJON|