Convertases and Pancreatic Cancer: Cohort of Patients Treated for Pancreatic Adenocarcinoma
ConditionPancreas Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut Bergonié
About this trial
This is a prospective, single-centre, observational study. The analysis of samples of pancreatic tumours and/or metastases taken during biopsy or surgery will lead to the determination of the level of expression of convertases in patients with pancreatic cancer and could be used as an additional prognostic means reinforcing those currently used.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years.
Indication for biopsy of metastasis(es) performed as part of standard care for patients who already have a histologically confirmed diagnosis of pancreatic cancer.
Indication for pancreatic surgery or metastasis(es) carried out as part of standard care for patients with a suspicion of pancreatic cancer on radiological assessment or who already have a confirmed histological diagnosis of pancreatic cancer.
Whatever the stage of the disease.
Disqualifiers
Indication for biopsy for primary diagnosis of pancreatic cancer
No indication for treatment of pancreatic cancer.
Adjuvant/neoadjuvant chemotherapy completed less than 6 months ago in the case of patients with recurrent disease.
Patient already included in the study.
Trial population
Patient with pancreatic adenocarcinoma (suspected on radiological assessment or histologically proven), whatever the stage of the disease ot the type of treatment proposed (systemic, surgery, radiotherapy, etc.), undergoing a biopsy or a surgery to collect tumor and blood samples.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood sample
Other interventionOn the same day as the tumour sample is taken (biopsy or surgery), a blood sample of approximately 15 to 20 mL is taken in EDTA-free tubes.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: CONVERCAP patients1 intervention
Trial outcomes
Primary outcomes
1
Correlation coefficients between level of expression of various convertases on the tumor and immune infiltrate
The level of expression of convertase proteins and their substrates (VEGF-C, IGF-1) will be determined on tumor samples at inclusion (healthy tissues, primary cancers and metastases), using qRT-PCR, western blot, ELISA, FACs and/or immunofluorescence as methodology and will be correlated with the following immune parameters, determined by immunofluorescence (including but not limited to): CD8, CD4, NK,Tregs, Macrophages The analysis will assess the correlation between the expression of various convertases on the tumor and immune parameters using Pearson's correlation coefficient for normally distributed variables, or Spearman's correlation coefficient for non-normally distributed variables. The correlation coefficient ranges from -1 to 1: a value closer to 1 indicates a strong positive association, a value closer to -1 indicates a strong negative association, and a value closer to 0 indicates no association.
Time frame
Inclusion, Day 1Secondary outcomes
1
Correlation coefficients between level of expression of various convertases determined at plasma level and immune infiltrate
The level of expression of convertase proteins will be determined at plasma level at inclusion, using qRT-PCR, western blot, ELISA, FACs and/or immunofluorescence as methodology and will be correlated with the following immune parameters, determined by immunofluorescence (including but not limited to): CD8, CD4, NK,Tregs, Macrophages. The analysis will assess the correlation between the expression of various convertases on plasma and immune parameters using Pearson's correlation coefficient for normally distributed variables, or Spearman's correlation coefficient for non-normally distributed variables. The correlation coefficient ranges from -1 to 1: a value closer to 1 indicates a strong positive association, a value closer to -1 indicates a strong negative association, and a value closer to 0 indicates no association.
Time frame
Inclusion, Day 1Sponsors and contacts
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Source ClinicalTrials.gov