Evaluation of GEMCITEST in Patients With Pancreatic Cancer and Treated by Chemotherapy
NCT ID: NCT03599154
Last Updated: 2021-05-24
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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COMPLETED
100 participants
OBSERVATIONAL
2018-01-30
2020-11-25
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Patient seeking first-line chemotherapy for pancreatic cancer
3. Age\> 18 years
4. Presence of at least 1 measurable tumor lesion according to RECIST 1.1 criteria
5. Performance index ≤ 2
6. Patient able and willing to comply with the study procedures according to the protocol
7. Patient able to understand, sign and date informed consent
8. Affiliation to a social security scheme.
Exclusion Criteria
2. Anti-tumor therapy, experimental or not, recent in the last 4 weeks before the inclusion of the patient
3. Active infection requiring antibiotics within 14 days before inclusion
4. Patients unable to understand, read and / or sign informed consent
5. Persons benefiting from a protection system for adults (including tutorship and guardianship)
6. Pregnant or lactating women
18 Years
ALL
No
Sponsors
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Centre Georges Francois Leclerc
OTHER
Responsible Party
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Principal Investigators
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François Ghiringhelli, PU PH
Role: STUDY_DIRECTOR
Centre Georges François Leclerc, DIJON
Locations
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Centre Georges François Leclerc
Dijon, , France
Countries
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Other Identifiers
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GEMCIPANC
Identifier Type: -
Identifier Source: org_study_id
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