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出境医 / 临床实验 / Microparticles in Peritoneal Carcinomatosis of Colorectal Origin

Microparticles in Peritoneal Carcinomatosis of Colorectal Origin

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.


Condition or disease Intervention/treatment Phase
Colorectal Carcinoma Other: blood draw, tumoral biopsy tissus Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Microparticles in Peritoneal Carcinomatosis of Colorectal Origin
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: colorectal cancer patient with peritoneal carcinosis Other: blood draw, tumoral biopsy tissus
Patient will have specific blood draw and part of their tumoral tissu biopsied
Active Comparator: colorectal cancer patient without metastasis Other: blood draw, tumoral biopsy tissus
Patient will have specific blood draw and part of their tumoral tissu biopsied
Outcome Measures
Primary Outcome Measures :
  1. percentage of microparticule [ Time Frame: 3 years ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Diane Mege, MD diane.mege@ap-hm.fr

Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Layout table for investigator information
Study Director: Emilie Garrido Assitance Publique Hopitaux de Marseille
Tracking Information
First Submitted Date  ICMJE May 28, 2019
First Posted Date  ICMJE May 31, 2019
Last Update Posted Date May 31, 2019
Estimated Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2019) 		percentage of microparticule [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Microparticles in Peritoneal Carcinomatosis of Colorectal Origin
Official Title  ICMJE Microparticles in Peritoneal Carcinomatosis of Colorectal Origin
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Colorectal Carcinoma
Intervention  ICMJE Other: blood draw, tumoral biopsy tissus
Patient will have specific blood draw and part of their tumoral tissu biopsied
Study Arms  ICMJE
  • Experimental: colorectal cancer patient with peritoneal carcinosis
    Intervention: Other: blood draw, tumoral biopsy tissus
  • Active Comparator: colorectal cancer patient without metastasis
    Intervention: Other: blood draw, tumoral biopsy tissus
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 28, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2023
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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: Diane Mege, MD diane.mege@ap-hm.fr
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03969784
Other Study ID Numbers  ICMJE 2019-A00688-49
2019-08 ( Other Identifier: Assistance Publique Hopitaux de Marseille )
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  ICMJE
Plan to Share IPD: No
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor  ICMJE Assistance Publique Hopitaux De Marseille
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Emilie Garrido Assitance Publique Hopitaux de Marseille
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date May 2019

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

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