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Efficacy of First-Line Gemcitabine Chemotherapy in GemCore+ Metastatic Pancreatic Adenocarcinoma Patients

Study acronym: GemSign-01
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Nov 1, 2027 → Nov 2029
See other at-risk trials from Institut Paoli-Calmettes

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Nov 1, 2027 to Nov 2029
    • Eligibility criteria expanded, about 14 words
  2. Re-verified, no change to tracked fieldsv6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 1, 2024 to May 23, 2024
    • Study sites: 0 to 1
    v5
  4. Start date: Dec 1, 2023 to Feb 1, 2024v4
  5. Start date: Nov 1, 2023 to Dec 1, 2023v3
  6. Re-verified, no change to tracked fieldsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06046794
Lead Sponsor Institut Paoli-Calmettes
Conditions
(from sponsor)		 Cancer Of Pancreas
Related terms Pancreatic Neoplasms
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov