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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

Tracking Information
First Submitted Date December 23, 2016
First Posted Date January 26, 2017
Last Update Posted Date April 10, 2018
Actual Study Start Date February 15, 2017
Actual Primary Completion Date November 13, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 24, 2017)
  • Step 1: sensitivity of CTC detection with 3 methods in cell spiking experiments [ Time Frame: 6 months ]
  • Step 2: diagnostic accuracy of the best CTC detection method and onco-exosome quantification for pancreatic adenocarcinoma diagnosis. [ Time Frame: 18 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 24, 2017)
  • 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.
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diagnostic Accuracy of Circulating Tumor Cells (CTCs) and Onco-exosome Quantification in the Diagnosis of Pancreatic Cancer - PANC-CTC
Official Title Diagnostic Accuracy of Circulating Tumor Cells (CTCs) and Onco-exosome Quantification in the Diagnosis of Pancreatic Cancer - PANC-CTC
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 20 patients with recent diagnosis of Pancreatic Ductal Adenocarcinoma and 20 patients with no cancer
Condition Pancreatic Ductal Adenocarcinoma (PDAC)
Intervention
  • 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
Study Groups/Cohorts
  • Pancreatic ductal adenocarcinoma patients
    Patients with recent diagnosis of pancreatic ductal adenocarcinoma (PDAC) or with strong suspicion PDAC
    Interventions:
    • Procedure: Blood samples
    • Procedure: Portal vein blood sample
  • Non-cancer patients
    Patients with no Cancer
    Intervention: Procedure: Blood samples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 9, 2018)
52
Original Estimated Enrollment
 (submitted: January 24, 2017)
40
Actual Study Completion Date November 13, 2017
Actual Primary Completion Date November 13, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03032913
Other Study ID Numbers CHUBX 2015/26
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Bordeaux
Study Sponsor University Hospital, Bordeaux
Collaborators Not Provided
Investigators
Principal Investigator: Etienne BUSCAIL University Hospital, Bordeaux
PRS Account University Hospital, Bordeaux
Verification Date April 2018