Peritoneal MetastasesSingleCellNCT05676372
Single-Cell Transcriptomics of the Peritoneal Microenvironment of Colorectal PC
An observational study of Peritoneal Metastases, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Single cell transcriptomics of CRC PC samples Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peritoneal Metastases
- What is being tested?
- CRC+HIPEC
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Jun 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing CRS+HIPEC
Who may be able to join
- Patients undergoing CRS+HIPEC for PC of colorectal origin
Who cannot join
- Previous HIPEC/PIPAC
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Ghent
Ghent, Oost-Vlaanderen, 9000
Wim P Ceelen, MD,PhD, 093326251 ext. +32, wim.ceelen@ugent.be
Jesse G Demuytere, MD
About this study
Official title: The Role of the Peritoneal Microenvironment in the Pathogenesis of Colorectal Peritoneal Carcinomatosis: Single-cell Transcriptomics
Single cell transcriptomics of CRC PC samples
Read the detailed description
Research methodology
Before inclusion of patients, patients will be screened for the presence of hepatitis B, hepatitis C and HIV to ensure researcher safety. During cytoreductive surgery, a total of five samples of tumoral tissue will be acquired. Three of those samples will be utilized for ScRNASeq analysis, and two samples of a macrometastasis will be snap frozen and cryopreserved.
Single-cell RNA-Sequencing analysis We will comprehensively catalog the stromal cell types in the microenvironment of colorectal cancer peritoneal metastases utilizing single-cell RNA sequencing (scRNAseq) on three samples (one of which should preferably originate from the omentum majus, to encompass milky spots) acquired from surgical waste material of patients undergoing cytoreductive surgery. After sample prelevation, samples will be transported as soon as possible while cooled and submerged in 10% PBS to the VIB facilities, where single cell suspensions will be made according to standard protocols. After cell selection by FACS (CD45+ and live/dead stain, to ensure a 50/50 mix of immune and stromal cells) and library prep, ScRNASeq will be performed.
Single cell sequencing analysis will allow us to identify cell clusters that by usage of marker genes will be assigned to different known cell lineages. After annotation of data, a "landscape" of the composition of the tumor stroma will be acquired.
- Conditions
- Peritoneal Metastases
- Being tested
- CRC+HIPEC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRC+HIPECProcedure or surgery
Sample prelevation of cytoreductive surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Single-cell transcriptomics
A transcriptional single-cell RNA seq atlas of gene expression data will be reported
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start16 Jun 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal MetastasesStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Flemish institute of biotechnology (VIB)
- Responsible party
- Sponsor
- Investigators
- Wim Ceelen, MD, PhD, Principal investigator, UZ Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676372
- Sponsor's protocol ID
- BC-6978
- Acronym
- SingleCell
- Status last verified
- Dec 2023
- First submitted
- 26 Nov 2020
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Peritoneal Microenvironment in the Pathogenesis of Colorectal Peritoneal Carcinomatosis: Single-cell Transcriptomics
- ClinicalTrials.gov ID
- NCT05676372
- Acronym / sponsor ID
- SingleCell / BC-6978
- Conditions
- Peritoneal Metastases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Flemish institute of biotechnology (VIB)
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Jan 2023 (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.
Single cell transcriptomics of CRC PC samples
Detailed description
Research methodology
Before inclusion of patients, patients will be screened for the presence of hepatitis B, hepatitis C and HIV to ensure researcher safety. During cytoreductive surgery, a total of five samples of tumoral tissue will be acquired. Three of those samples will be utilized for ScRNASeq analysis, and two samples of a macrometastasis will be snap frozen and cryopreserved.
Single-cell RNA-Sequencing analysis We will comprehensively catalog the stromal cell types in the microenvironment of colorectal cancer peritoneal metastases utilizing single-cell RNA sequencing (scRNAseq) on three samples (one of which should preferably originate from the omentum majus, to encompass milky spots) acquired from surgical waste material of patients undergoing cytoreductive surgery. After sample prelevation, samples will be transported as soon as possible while cooled and submerged in 10% PBS to the VIB facilities, where single cell suspensions will be made according to standard protocols. After cell selection by FACS (CD45+ and live/dead stain, to ensure a 50/50 mix of immune and stromal cells) and library prep, ScRNASeq will be performed.
Single cell sequencing analysis will allow us to identify cell clusters that by usage of marker genes will be assigned to different known cell lineages. After annotation of data, a "landscape" of the composition of the tumor stroma will be acquired.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing CRS+HIPEC
Key inclusion criteria (1 listed)
- Patients undergoing CRS+HIPEC for PC of colorectal origin
Key exclusion criteria (1 listed)
- Previous HIPEC/PIPAC
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 |
|---|---|---|
| CRC+HIPECSample prelevation of cytoreductive surgery | Procedure or surgery | – |
Primary outcome
Single-cell transcriptomics
Time frame: 24 months
A transcriptional single-cell RNA seq atlas of gene expression data will be reported
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Wim Ceelen, MD, PhD principal investigator
UZ Ghent
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 Peritoneal Metastases, run by University Hospital, Ghent at 1 site in Belgium.
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 1 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: status not confirmed, as of the sponsor's last update on 28 Dec 2023. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wim P Ceelen, MD, PhD (093326251 ext. +32, wim.ceelen@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single-cell transcriptomics (time frame: 24 months). 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 28 Dec 2023.