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Evaluation of GEMCITEST in Patients With Pancreatic Cancer and Treated by Chemotherapy

NCT03599154 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2021-05-24

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Centre Georges Francois Leclerc

    lead OTHER

Principal Investigators

  • François Ghiringhelli, PU PH · Centre Georges François Leclerc, DIJON

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-30
Primary Completion
2020-11-25
Completion
2020-11-25

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03599154 on ClinicalTrials.gov