PITCHER (Peritoneal Carcinomatosis Heterogeneity)

Colorectal Cancer Clinical Trial

Official title:

PITCHER (Peritoneal Carcinomatosis Heterogeneity)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04714957
• Other study ID #: 69HCL16_0672
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: September 2027

Study information

• Verified date: January 2021
• Source: Hospices Civils de Lyon
• Contact: Olivier GLEHEN, MD
• Phone: +33 4 78 86 23 71
• Email: olivier.glehen[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

How epigenetic deregulation affects gene expression patterns in subclones of the same tumor is poorly known. Peritoneal Carcinomatosis (PC) is a condition in which multiple metastases of the same abdominal tumor develop in the peritoneal cavity and intra-peritoneal organs, thus defining different ecosystems of the same cancer. PITCHER addresses the variations in epigenetically regulated gene expression between different subclones of PC in relation with cell mechanoresponses, providing insights on how cancer epigenetic landscapes evolve under environmental pressures and on strategies used by cancer cells to adapt to the transition from one ecosystem to the other.

PITCHER is a network of 10 teams from Lyon, Grenoble and Marseille, based on data and specimen collection of patients who have undergone a surgery for a peritoneal carcinomatosis of ovarian or colorectal origin. PC lesions and eventually matched specimens of primary tumors will be collected in the same patients at the time of the surgery or eventually retrieved from already existing samples. Epigenetic landscapes will be analyzed by a bioinformatics pipeline combining exome sequencing, transcriptome and methylome to identify "epigenetic hotspots", and their variations across lesions will be evaluated. These analyses will be realized in fresh (when available) or pre-existing samples. When possible, organoid cultures and animal models will be derived from multicellular structures in peritoneal fluids and membrane, cytoskeletal and nucleoskeletal mechanoresponses will be characterized using Atomic Force Microscopy. The role of tumor axonogenesis, a process of neo-formation of axon fibers in tumors, will be addressed. Experimental studies of cell responses to therapy will be performed to derive mathematical predictive models. All components will be integrated in a systems biology map of PC.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2027
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who accept to participate to the study

• Men / women aged over 18 years

• Patients with cancer management and care for peritoneal carcinomatosis of digestive or ovarian origin

• Patients had histologic/radiologic confirmation of peritoneal disease

• Serology negative HIV, HEPATITIS

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Carcinoma
• Colorectal Cancer
• Ovarian Cancer
• Peritoneal Neoplasms
• Secondary Peritoneal Cancers

Intervention

Other:
• construction of a database of genetic and epigenetic data on peritoneal carcinomatosis of colorectal or ovarian origin.
Construction of a core database of genetic and epigenetic markers, in order to identify predictive biomarkers and potentially actionable targets for controlling the spread of peritoneal carcinomatosis.

Locations

Country	Name	City	State
France	Lyon SUD Hospital, Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	genetic and epigenetic data available for 20 "multiplets" biospecimens (peritoneal carcinomatosis + healthy tissue + primary tumor + tissue from other tumor metastasis - when applicable and available- )	The main endpoint is to implement a specific tissue collection of appropriate quality, assembling "multiplets" of biospecimens from the same patient, in order to construct a core database for research on mechanisms, biomarkers and actionable therapeutic targets in PC. This database will include molecular analysis by next-generation sequencing of whole-exome genetic, transcriptomic and epigenetic patterns of primary, peritoneal and metastatic lesions. "Omics" data are compiled using a data model also including anonymized information on histopathology and clinical history of treatments (when applicable)	end of the inclusion period (September 2022)