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Trial record 2 of 9 for:    calcium electroporation

Calcium Electroporation for Early Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03694080
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Zealand University Hospital

Tracking Information
First Submitted Date  ICMJE September 25, 2018
First Posted Date  ICMJE October 3, 2018
Last Update Posted Date July 5, 2019
Actual Study Start Date  ICMJE November 1, 2018
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 42 days ]
Safety will be evaluated through registration of adverse events related to the treatment. CTCAE will be used
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
  • Histopathological characterization of the tumor [ Time Frame: 14 days ]
    ypTNM staging and tumor regression grade according to current standards
  • Immunologic infiltration of the tumor tissue after calcium electroporation [ Time Frame: 14 days ]
    Specific immunohistochemical staining for PD-1/PD-L1, CD3 and CD8 will be performed on biopsies and the final surgical specimen.
  • Immunoscore classification [ Time Frame: 14 days ]
    Tumor infiltration on T-cells and subtypes will be characterized according to the immunoscore classification system.
  • Systemic immune response according to cytokine analysis [ Time Frame: 42 days ]
    Blood samples will be collected prior to calcium electroporation and again at follow-up. Multiplex cytokine analysis will be performed
  • Systemic immune response according to flow cytometri [ Time Frame: 42 days ]
    Blood samples will be collected prior to calcium electroporation and again at follow-up. Flow cytometri will be performed to evaluate immunological changes to the treatment.
  • Metastatic ability after potentially curable surgery [ Time Frame: 42 days ]
    Cell adhesion assay will be performed on blood samples to evalutate the metastatic ability.
  • Cell proliferation as a marker for metastatic ability [ Time Frame: 42 days ]
    Cell proliferation analyses will be performed on blood samples to evaluate metastatic ability
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Calcium Electroporation for Early Colorectal Cancer
Official Title  ICMJE Calcium Electroporation for Early Colorectal Cancer
Brief Summary This is an explorative, phase I clinical trial. The aim of this study is to establish the safety and efficacy of treating patients with early colorectal cancer with calcium electroporation prior to intended curative surgery.
Detailed Description

This is an explorative, phase I clinical trial. The aim of this study is to establish the safety and efficacy of treating patients with early colorectal cancer with calcium electroporation as a down staging and immune-response enhancing treatment prior to intended curative surgery. The study involves recruitment of patients with histologically verified rectal and sigmoid colon cancer with no indication for neoadjuvant chemoradiotherapy (experimental or standard care based) prior to intended curative surgery. In total the study will involve 24 patients, of these, 12 patients with rectal cancer and 12 patients with sigmoid colon cancer.

In relation to the intervention, clinical examination, blood samples, biopsies and questionnaires will be collected to evaluate safety, tumor respons and immunologic response to the treatment.

Patients will be followed for one month after the elective surgery.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE Combination Product: Calcium electroporation
Patients with potentially curable colorectal rectal cancer will be treated preoperatively
Study Arms  ICMJE Experimental: Calcium Electroporation treatment
Calcium electroporation for colorectal cancer as a preoperative treatment before elective surgery.
Intervention: Combination Product: Calcium electroporation
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  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 1, 2018)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2020
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • • Patients must be mentally capable of understanding the information given.

    • Patients must give written informed consent.
    • Histologically verified adenocarcinoma of the rectum or sigmoid colon.
    • Tumor described as passable at index endoscopy.
    • Men or women aged at least 18 years.
    • Case reviewed by MDT (surgery, radiology, oncology). Case considered curable with standard surgical resection.
    • ASA class I-II (Classification of the American Society of Anesthesiology)

Exclusion Criteria:

  • • Uncorrectable coagulation disorder.

    • Highly inflamed gastrointestinal tissue which is ulcerated and bleeding
    • Patients with ICD or pacemaker units.
    • Ongoing immunosuppressive treatment.
    • Patients with concomitant use of phenytoin.
    • Concurrent treatment with an investigational medicinal product.
    • Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study recruitments.
    • Advanced tumor stages, clinical UICC stage IV.
    • Indication for neoadjuvant chemoradiation or chemotherapy prior to surgery
    • Acute surgical resection.
    • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Malene Broholm Andersen, MD +45 41272742 malea@regionsjaelland.dk
Contact: Ismail Gögenur, DMSc igo@regionsjaelland.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03694080
Other Study ID Numbers  ICMJE REG-188-2017
Has Data Monitoring Committee Yes
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  ICMJE
Plan to Share IPD: Undecided
Responsible Party Zealand University Hospital
Study Sponsor  ICMJE Zealand University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ismail Gögenur, DMSc Zealand University Hospital
PRS Account Zealand University Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP