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Microparticles in Peritoneal Carcinomatosis of Colorectal Origin

Primary Purpose

Colorectal Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
blood draw, tumoral biopsy tissus
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patient presenting a peritoneal carcinomatosis from colorectal cancer origin

Exclusion Criteria:

  • patient presenting a peritoneal carcinomatosis from other pathologies than colorectal cancer origin

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    colorectal cancer patient with peritoneal carcinosis

    colorectal cancer patient without metastasis

    Arm Description

    Outcomes

    Primary Outcome Measures

    percentage of microparticule

    Secondary Outcome Measures

    Full Information

    First Posted
    May 28, 2019
    Last Updated
    May 28, 2019
    Sponsor
    Assistance Publique Hopitaux De Marseille
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03969784
    Brief Title
    Microparticles in Peritoneal Carcinomatosis of Colorectal Origin
    Official Title
    Microparticles in Peritoneal Carcinomatosis of Colorectal Origin
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2019 (Anticipated)
    Primary Completion Date
    August 31, 2022 (Anticipated)
    Study Completion Date
    August 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique Hopitaux De Marseille

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Peritoneal carcinomatosis (PC), a tumoral tumor of the peritoneum, is a frequent metastatic localization of colorectal cancer (CRC, 13%). Long regarded as a palliative situation, its management has progressed significantly with a curative treatment based on a complete cytoreduction surgery coupled with intraperitoneal hyperthermic chemotherapy. However current screening tools, tumor markers (ACE, CA19-9, CA125) and abdominopelvic CT scan are insufficient, to diagnose CP early. A non-invasive biomarker, more sensitive and more specific than currently available tumor markers, would be a major advance in oncology. Microparticles (MPs), vesicles from extracellular membrane budding in response to cell activation or apoptosis of different cell types, have been described as implicated in tumor progression, procoagulant activity associated with cancer, and initiation of metastatic niches. A specific microparticulate (microparticulosome) signature has been reported in patients with CRC, particularly in the presence of a thromboembolic event. However, there is currently no data on PMs and their involvement in CP. In addition, CP and surgery coupled with hyperthermic intraperitoneal chemotherapy are major risk factors for thromboembolic complications. The characterization of prothrombotic PMs is therefore essential to predict such event. The main objective of this project is to characterize the microparticulate signature of CP of colorectal origin and to compare it with that of CP without CP. The secondary objectives are to compare the microparticulate signature obtained on peripheral venous samples and intraoperative tumor samples, evaluate the evolution of the microparticulate signature between the beginning and the end of the intervention, then correlate the peripheral signature to the oncological follow-up of the patients with CP and the occurrence of a thromboembolic event.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Carcinoma

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    colorectal cancer patient with peritoneal carcinosis
    Arm Type
    Experimental
    Arm Title
    colorectal cancer patient without metastasis
    Arm Type
    Active Comparator
    Intervention Type
    Other
    Intervention Name(s)
    blood draw, tumoral biopsy tissus
    Intervention Description
    Patient will have specific blood draw and part of their tumoral tissu biopsied
    Primary Outcome Measure Information:
    Title
    percentage of microparticule
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patient presenting a peritoneal carcinomatosis from colorectal cancer origin Exclusion Criteria: patient presenting a peritoneal carcinomatosis from other pathologies than colorectal cancer origin
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Diane Mege, MD
    Email
    diane.mege@ap-hm.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Emilie Garrido
    Organizational Affiliation
    Assitance Publique Hopitaux de Marseille
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Microparticles in Peritoneal Carcinomatosis of Colorectal Origin

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