Efficacy of First-Line Gemcitabine Chemotherapy in GemCore+ Metastatic Pancreatic Adenocarcinoma Patients
NCT ID: NCT06046794
Last Updated: 2025-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-05-23
2027-11-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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metastatic pancreatic adenocarcinoma patients
Analyze of GemCore status
Analyze of GemCore status
Genomic analyze of GemCore status
Interventions
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Analyze of GemCore status
Genomic analyze of GemCore status
Eligibility Criteria
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Inclusion Criteria
* 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;
* Measurable target according to RECIST 1.1 criteria;
* No previous treatment in metastatic situation;
* Age ≥ 18 years;
* Patient not opposed to study participation;
* Affiliation to a social security system, or beneficiary of such a scheme.
Exclusion Criteria
* 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);
* Unable to undergo medical follow-up for geographical, social or psychological reasons.
18 Years
ALL
No
Sponsors
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Institut Paoli-Calmettes
OTHER
Responsible Party
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Locations
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Institut Paoli Calmettes
Marseille, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GemSign-01-IPC 2022-068
Identifier Type: -
Identifier Source: org_study_id
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