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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06046794
Other study ID # GemSign-01-IPC 2022-068
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 1, 2024
Est. completion date November 1, 2027

Study information

Verified date September 2023
Source Institut Paoli-Calmettes
Contact Dominique GENRE, Dr
Phone 0491223778
Email drci.up@ipc.unicancer.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date November 1, 2027
Est. primary completion date November 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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; - 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: - 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); - Unable to undergo medical follow-up for geographical, social or psychological reasons.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Analyze of GemCore status
Genomic analyze of GemCore status

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Institut Paoli-Calmettes

Outcome

Type Measure Description Time frame Safety issue
Other Overall survival of GemCore- patients Overall survival of GemCore- patients 24 months
Primary Percentage of alive GemCore+ patients treated with Gemcitabine Percentage of alive GemCore+ patients treated with Gemcitabine 12 months
Secondary Overall survival Overall survival 24 months
Secondary Tumor response rate Tumor response rate 24 months
Secondary Progression-free survival Progression-free survival 24 months
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