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Diagnostic Accuracy of Circulating Tumor Cells (CTCs) and Onco-exosome Quantification in the Diagnosis of Pancreatic Cancer - PANC-CTC (PANC-CTC)

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ClinicalTrials.gov Identifier: NCT03032913
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
The proposal aims at determining whether liquid biopsy approaches are valid in the diagnosis of pancreatic cancer. Step1 will test 3 CTC isolation methods and analyse by flow cytometry the presence of onco-exosomes in the culture media of pancreatic cell lines. Step 2 will examine the diagnostic accuracy of these blood tumor elements for the diagnosis of cancer of patients with PDAC suspicion or recent diagnosis and their value for disease monitoring.

Condition or disease Intervention/treatment
Pancreatic Ductal Adenocarcinoma (PDAC) Procedure: Blood samples Procedure: Portal vein blood sample

Detailed Description:
Pancreatic ductal adenocarcinoma (PDAC) incidence has increased with a high rate during the past few years (+4.7% per year between 2005 and 2012, source InfoCancer 2013). No cure is currently available for this deadly disease, with an overall survival <5%. Survival can reach 20% when surgery is possible, giving the best chance to the patients. If patients present locally advance disease, it is crucial to quickly establish resectability to avoid unneeded and even deleterious surgery in patients with metastatic stages. It is also important to increase the rate of true R0 resection with effective preoperative therapy. However, when the cancer is suspected, neoadjuvant chemotherapies are often delayed because the mandatory histologic proof is difficult to make with non-informative biopsies. It is necessary to find new markers to help for rapid diagnosis that could allow neoadjuvant therapies and surgery when anatomo-pathologic proof is not available. New developments in the field of liquid biopsy hold great promise in providing valuable information for diagnosis assistance. The project will be run in two steps. First, several methods will be compared for tumor cell recovery after cell spiking in blood of non-cancer patients and pancreatic cell line onco-exosomes will characterized by flow cytometry. Second the best method will be used to detect and enumerate CTCs in 20 PDAC patients and 20 non-cancer patients. In parallel GPC1+ exosomes from patients' plasmas will be quantified. Diagnosis accuracy will be established and compared. Correlations between circulating tumor elements presence and clinical and biological parameters will be evaluated at the time of the diagnosis. Patient clinical outcome will be assessed according to initial circulating element quantification.

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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic Accuracy of Circulating Tumor Cells (CTCs) and Onco-exosome Quantification in the Diagnosis of Pancreatic Cancer - PANC-CTC
Actual Study Start Date : February 15, 2017
Actual Primary Completion Date : November 13, 2017
Actual Study Completion Date : November 13, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pancreatic ductal adenocarcinoma patients
Patients with recent diagnosis of pancreatic ductal adenocarcinoma (PDAC) or with strong suspicion PDAC
Procedure: Blood samples
Blood samples for both group

Procedure: Portal vein blood sample
Portal vein blood sample during surgery procedure for the Pancreatic Ductal Adenocarcinoma group

Non-cancer patients
Patients with no Cancer
Procedure: Blood samples
Blood samples for both group




Primary Outcome Measures :
  1. Step 1: sensitivity of CTC detection with 3 methods in cell spiking experiments [ Time Frame: 6 months ]
  2. Step 2: diagnostic accuracy of the best CTC detection method and onco-exosome quantification for pancreatic adenocarcinoma diagnosis. [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Step 1: reproducibility of CTC detection with the 3 methods [ Time Frame: 6 months ]
    Estimation with bilateral confidence interval of 95%. A mixed affect linear regression will be operated to obtain this estimation.

  2. Step 2: correlation between CTCs presence and numbers or onco-exosome concentration with clinical and biological parameters and with patient clinical outcome [ Time Frame: 18 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
20 patients with recent diagnosis of Pancreatic Ductal Adenocarcinoma and 20 patients with no cancer
Criteria

Inclusion Criteria:

  • Patient with informed consent
  • Patient with health care coverage
  • Group of PDAC patients: Patient with resectable lesion with suspicion or recent diagnosis of PDAC recruited in the surgery department
  • Group of non-cancer patients: Patients in the surgery department without cancer lesion, Patients with intestine inflammatory disease, Patients with gastric bypass or sleeve gastrectomy procedure

Exclusion Criteria:

  • Patients <18 or under tutelage
  • Patient with recent chemotherapy or radiotherapy
  • Pregnant or lactating woman
  • Patient with negative or non-informative biopsy
  • Patient with technically unserectable disease

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): NCT03032913


Locations
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France
Chu de Bordeaux
Bordeaux, France
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Etienne BUSCAIL University Hospital, Bordeaux
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03032913    
Other Study ID Numbers: CHUBX 2015/26
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 University Hospital, Bordeaux:
Pancreas
Pancreatic
Cancer
Circulating tumor cell (CTC)
Adenocarcinoma
Ductal
Exosome
Additional relevant MeSH terms:
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Adenocarcinoma
Neoplastic Cells, Circulating
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes