About this trial
The goal of this interventional study is to learn about the efficacy of first-line chemotherapy with Gemcitabine in metastatic pancreatic adenocarcinoma patients expressing the GemCore signature in their tumor. The main question it aims to answer is to assess efficacy of Gemcitabine (tumor response, survival rate) in the population of patient bearing the GemCore signature.
Participants will start the chemotherapy with Gemcitabine as usually performed in standard care of their center. They will consent to a genomic analyze of their tumor to know if it bears the GemCore signature. The center will manage the participant's follow up as usually realized in standard care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Metastatic pancreatic adenocarcinoma histological proved
FOLFIRINOX chemotherapy-ineligible patient and going to receive first-line metastatic chemotherapy with gemcitabine monotherapy
Tumor material allowing assessment of GEMCore status (i.e. FFPE block with tumor cellularity ≥ 10%);
Life expectancy > 2 months;
Disqualifiers
Contraindication to Gemcitabine treatment;
ECOG performance status ≥ 3;
Person in emergency situation or unable to express non-opposition;
Patient under a legal protection measure (adult under guardianship, curatorship or safeguard of justice);
Trial design
Single group
Treatments tested in this trial
Analyze of GemCore status
Other interventionGenomic analyze of GemCore status
Treatment groups
Trial outcomes
Primary outcomes
Percentage of alive GemCore+ patients treated with Gemcitabine
Percentage of alive GemCore+ patients treated with Gemcitabine
Secondary outcomes
Overall survival
Overall survival
Tumor response rate
Tumor response rate
Progression-free survival
Progression-free survival
Other outcomes
Overall survival of GemCore- patients
Overall survival of GemCore- patients
Sponsors and contacts
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