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
About this trial
This is an interventional diagnostic trial for Colorectal Carcinoma
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
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
NCT ID
NCT03969784
First Posted
May 28, 2019
Last Updated
May 28, 2019
Sponsor
Assistance Publique Hopitaux De Marseille
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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