Microparticles in Peritoneal Carcinomatosis of Colorectal Origin

NCT ID: NCT03969784

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2025-03-03

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.

Conditions

Colorectal Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

colorectal cancer patient with peritoneal carcinosis

Group Type: EXPERIMENTAL

blood draw, tumoral biopsy tissus

Intervention Type: OTHER

Patient will have specific blood draw and part of their tumoral tissu biopsied

colorectal cancer patient without metastasis

Group Type: ACTIVE_COMPARATOR

blood draw, tumoral biopsy tissus

Intervention Type: OTHER

Patient will have specific blood draw and part of their tumoral tissu biopsied

Interventions

blood draw, tumoral biopsy tissus

Patient will have specific blood draw and part of their tumoral tissu biopsied

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emilie Garrido

Role: STUDY_DIRECTOR

Assitance Publique Hopitaux de Marseille

Locations

Timone

Marseille, , France

Countries

France

Other Identifiers

2019-08

Identifier Type: OTHER

Identifier Source: secondary_id

2019-A00688-49

Identifier Type: -

Identifier Source: org_study_id