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Recruiting NCT04714957

PITCHER (Peritoneal Carcinomatosis Heterogeneity)

Observational Secondary Peritoneal Cancers Colorectal Cancer Ovarian Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: construction of a database of genetic and epigenetic data on peritoneal carcinomatosis of colorectal or ovarian origin..
Who it may be relevant to
Registry conditions: Secondary Peritoneal Cancers, Colorectal Cancer, Ovarian Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • genetic and epigenetic data available for 20 "multiplets" biospecimens (peritoneal carcinomatosis + healthy tissue + primary tumor + tissue from other tumor metastasis - when applicable and available- ) [Time frame: end of the inclusion period (September 2022)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

France · 1 center
  • Lyon SUD Hospital, Hospices Civils de Lyon — Lyon

Identifiers

NCT: NCT04714957 · 69HCL16_0672

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗