Secondary Peritoneal CancersNCT04714957
PITCHER (Peritoneal Carcinomatosis Heterogeneity)
An observational study of Secondary Peritoneal Cancers and Colorectal Cancer, run by Hospices Civils de Lyon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Peritoneal Cancers, Colorectal Cancer, Ovarian Cancer
- What is being tested?
- construction of a database of genetic and epigenetic data on peritoneal carcinomatosis of colorectal or ovarian origin.
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2020to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Lyon SUD Hospital, Hospices Civils de Lyon
Lyon
Olivier GLEHEN, MD, +33 4 78 86 23 71, olivier.glehen@chu-lyon.fr
About this study
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.
- Being tested
- construction of a database of genetic and epigenetic data on peritoneal carcinomatosis of colorectal or ovarian origin.
- Keywords
- peritoneal carcinomatosis, tumor heterogeneity, epigenetic landscape
- Medical subject headings
- Colorectal Neoplasms, Ovarian Neoplasms, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
construction of a database of genetic and epigenetic data on peritoneal carcinomatosis of colorectal or ovarian origin.Other
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: end of the inclusion period (September 2022)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start1 Sep 2020
- Primary completionSep 2022 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Peritoneal CancersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714957
- Sponsor's protocol ID
- 69HCL16_0672
- Status last verified
- Jan 2021
- First submitted
- 14 Jan 2021
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PITCHER (Peritoneal Carcinomatosis Heterogeneity)
- ClinicalTrials.gov ID
- NCT04714957
- Acronym / sponsor ID
- 69HCL16_0672
- Keywords
- peritoneal carcinomatosis, tumor heterogeneity, epigenetic landscape
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | – |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Secondary Peritoneal Cancers and Colorectal Cancer, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier GLEHEN, MD (+33 4 78 86 23 71, olivier.glehen@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.