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Evaluation of GEMCITEST in Patients With Pancreatic Cancer and Treated by Chemotherapy (GEMCIPANC)

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ClinicalTrials.gov Identifier: NCT03599154
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Georges Francois Leclerc

Brief Summary:

Pancreatic cancer has a 5-year overall survival rate around 5%. It is the 6th most common cancer in France (11 600 new annual cases in 2012) and the 4th leading cause of cancer deaths in France and Europe.

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.


Condition or disease
Pancreatic Cancer

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Evaluation of GEMCITEST in Patients With Pancreatic Cancer and Treated by Chemotherapy
Actual Study Start Date : January 30, 2018
Actual Primary Completion Date : January 30, 2018
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Overall survival [ Time Frame: average of 1 year ]
    Overall survival is defined as survival between Day 1 of the first line of chemotherapy and death


Biospecimen Retention:   Samples Without DNA
blood sample


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patient with pancreatic cancer
Criteria

Inclusion Criteria:

  1. Cytologically or histologically confirmed pancreatic cancer
  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:

  1. Contraindication to chemotherapy
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599154


Contacts
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Contact: François Ghiringhelli, PU PH 03.80.73.75.00 FGhiringhelli@cgfl.fr
Contact: Emilie REDERSTORFF 03 45 34 81 16 erederstorff@cgfl.fr

Locations
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France
Centre Georges François Leclerc Recruiting
Dijon, France, 21000
Contact: François Ghiringhelli, PU PH    03.80.73.75.00    FGhiringhelli@cgfl.fr   
Sponsors and Collaborators
Centre Georges Francois Leclerc
Investigators
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Study Director: François Ghiringhelli, PU PH Centre Georges François Leclerc, DIJON

Additional Information:

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Responsible Party: Centre Georges Francois Leclerc
ClinicalTrials.gov Identifier: NCT03599154     History of Changes
Other Study ID Numbers: GEMCIPANC
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Georges Francois Leclerc:
Gemcitabine
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases