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PITCHER (Peritoneal Carcinomatosis Heterogeneity)

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ClinicalTrials.gov Identifier: NCT04714957
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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.


Condition or disease Intervention/treatment
Secondary Peritoneal Cancers Colorectal Cancer Ovarian Cancer Other: construction of a database of genetic and epigenetic data on peritoneal carcinomatosis of colorectal or ovarian origin.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: PITCHER (Peritoneal Carcinomatosis Heterogeneity)
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2027

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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 :
  1. 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) ]
    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)


Biospecimen Retention:   Samples With DNA
tumor samples (peritoneal carcinomatosis, primary tumor, other tumor metastasis (when applicable)), healthy tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with cancer management and care for peritoneal carcinomatosis of digestive or ovarian origin. PITCHER will include patients who will undergo surgery for peritoneal carcinomatosis or patients who already undergone surgery for peritoneal carcinomatosis
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04714957


Contacts
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Contact: Olivier GLEHEN, MD +33 4 78 86 23 71 olivier.glehen@chu-lyon.fr
Contact: Sara CALATTINI, CRA +33 4 78 86 37 79 sara.calattini@chu-lyon.fr

Locations
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France
Lyon SUD Hospital, Hospices Civils de Lyon Recruiting
Lyon, France
Contact: Olivier GLEHEN, MD    +33 4 78 86 23 71    olivier.glehen@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04714957    
Other Study ID Numbers: 69HCL16_0672
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
peritoneal carcinomatosis
tumor heterogeneity
epigenetic landscape
Additional relevant MeSH terms:
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Carcinoma
Peritoneal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Abdominal Neoplasms
Peritoneal Diseases