Peritoneal (Metastatic) CancerPROCPHGPNCT07474025
Biopsy-Resection Agreement of Peritoneal Histopathological Growth Patterns in Colorectal Peritoneal Metastases: A Prospective Observational Pilot Study
An observational study of Peritoneal (Metastatic) Cancer and Colorectal Cancer, run by Jules Bordet Institute at 2 sites in Belgium.
Trial summary
his prospective, single-center observational pilot study evaluates whether peritoneal histopathological growth patterns can be assessed on limited excisional biopsies obtained during staging laparoscopy in adults with suspected or confirmed colorectal peritoneal metastases. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Peritoneal (Metastatic) Cancer, Colorectal Cancer, Colorectal (Colon or Rectal) Cancer
- How many people
- 30 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Mar 2026to Dec 2028
- 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 Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of adult patients with histologically confirmed colorectal cancer and suspected or confirmed peritoneal metastases who undergo surgical evaluation or treatment (staging laparoscopy and/or cytoreductive surgery ± HIPEC) as part of routine clinical care at participating centers. Peritoneal metastasis tissue samples obtained during these procedures are used for histopathological analysis to evaluate histological growth patterns and their association with clinicopathological characteristics and clinical outcomes.
Who may be able to join
- Age ≥ 18 years
- Histologically confirmed colorectal adenocarcinoma
- Suspected or confirmed peritoneal metastases from colorectal cancer based on imaging or prior clinical evaluation
- Patients undergoing staging laparoscopy and/or cytoreductive surgery (CRS) ± hyperthermic intraperitoneal chemotherapy (HIPEC) as part of standard clinical care
- Availability of peritoneal metastasis tissue samples suitable for histopathological analysis
- Written informed consent provided for participation in the study
Who cannot join
- Age < 18 years
- Peritoneal metastases originating from non-colorectal primary tumors
- Absence of available or adequate peritoneal metastasis tissue samples for histological growth pattern analysis
- Patients who decline or withdraw informed consent
- Patients unable to provide informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Recruiting
Institut Jules Bordet
Brussels, Brussels Capital, 1070
Gabriel Liberale, MD, pHD, 0494817818, gabriele.liberale@hubruxelles.be
Ali Channawi, MD, ali.channawi@ulb.be
- Not yet recruiting
Hub Bordet
Brussels, 1070
Ali CHANNAWI, MD, +32494817818, ali.channawi@ulb.be
ali.channawi@ulb.be
About this study
his prospective, single-center observational pilot study evaluates whether peritoneal histopathological growth patterns can be assessed on limited excisional biopsies obtained during staging laparoscopy in adults with suspected or confirmed colorectal peritoneal metastases. The study primarily evaluates agreement between the dominant histopathological growth pattern identified on laparoscopic biopsy and that identified on subsequent operative specimens.
One to three peritoneal deposits will be sampled during staging laparoscopy. When surgery proceeds, up to three peritoneal deposits will be collected from the operative specimen, preferably from corresponding Peritoneal Cancer Index regions. Two pathologists, blinded to clinical information, specimen timing, and each other's assessments, will independently estimate the proportions of pushing and infiltrating growth patterns.
Histopathological growth pattern findings will not be used to guide clinical management. Biopsy evaluability, interobserver reproducibility, interlesional heterogeneity, and exploratory associations with clinical and surgical characteristics will also be assessed.
Read the detailed description
Peritoneal histopathological growth patterns (HGPs) describe the morphological interface between metastatic tumor deposits and the surrounding peritoneal tissue and may provide biological information that is not captured by conventional clinical or pathological variables. This prospective, single-center observational pilot study aims to determine whether peritoneal HGPs can be reliably assessed on limited biopsies obtained during staging laparoscopy and whether the dominant HGP identified on these biopsies agrees with that identified on subsequent cytoreductive surgery (CRS) specimens. Thirty adult patients with colorectal peritoneal metastases who are scheduled to undergo both staging laparoscopy and cytoreductive surgery, with or without hyperthermic intraperitoneal chemotherapy, will be prospectively enrolled.
During staging laparoscopy, one to three peritoneal deposits will be sampled using cold scissors. CRS will subsequently be performed within eight weeks, without interval systemic anticancer treatment. During CRS up to three additional peritoneal deposits will be collected, preferably from the same PCI regions or anatomical compartments as the laparoscopic samples. Two pathologists, blinded to clinical information, specimen timing, and each other's assessments, will independently estimate the proportions of pushing and infiltrating HGP at the tumor-peritoneum interface according to a prespecified histopathological standard operating procedure. The primary outcome will be patient-level agreement in dominant HGP classification between staging-laparoscopy biopsies and cytoreductive surgery specimens. Secondary outcomes will include biopsy evaluability, interobserver agreement, agreement in continuous HGP proportions, interlesional heterogeneity, and exploratory associations between HGP and primary-tumor characteristics, PCI, and completeness of cytoreduction. Overall survival and disease-free survival will be explored descriptively; however, the study is not powered to establish the prognostic value or clinical utility of HGP. HGP assessments will not be used to guide treatment decisions, which will remain based on standard multidisciplinary clinical evaluation.
- Conditions
- Peritoneal (Metastatic) Cancer, Colorectal Cancer, Colorectal (Colon or Rectal) Cancer, Histopathological Growth Patterns (HGPs)
- Keywords
- Peritoneal cancer, Colorectal cancer, Histopathological Growth Patterns
- Medical subject headings
- Neoplasm Metastasis, Neoplasms, Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with colorectal peritoneal metastases | Adult patients with histologically confirmed colorectal cancer and suspected or confirmed peritoneal metastases undergoing standard-of-care surgical evaluation or treatment (staging laparoscopy and/or cytoreductive surgery ± HIPEC). Peritoneal metastasis tissue samples obtained during routine clinical care are analyzed histologically to assess histological growth patterns and their association with clinical and pathological outcomes. No experimental intervention is performed as part of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of peritoneal histopathological growth pattern classification between staging-laparoscopy biopsies and subsequent cytoreductive surgery specimens.
Histological characterization of colorectal peritoneal metastases according to predefined histological growth pattern criteria (e.g., pushing, infiltrative/replacement, or mixed patterns) on hematoxylin and eosin (H\&E)-stained tissue sections obtained from peritoneal biopsies or surgical specimens. The proportion of each HGP type will be determined.
Measured: At time of histopathological analysis of surgical or laparoscopic biopsy specimens (baseline, during initial surgical evaluation).
Secondary outcomes (3)
Association between histological growth patterns and peritoneal disease burden
Assessment of the relationship between histological growth pattern and extent of peritoneal disease as measured by the Peritoneal Cancer Index (PCI).
Measured: At time of surgery or staging laparoscopy.
Association between histological growth patterns and histopathological tumor characteristics
Evaluation of associations between HGP and tumor-related characteristics including differentiation grade, molecular markers, and other pathological features of colorectal cancer.
Measured: At time of histopathological analysis.
Association between histological growth patterns and survival outcomes
Evaluation of the relationship between HGP and clinical outcomes including overall survival and progression-free survival.
Measured: Up to 2 years after surgery or diagnosis of peritoneal metastases.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Mar 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal (Metastatic) CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474025
- Sponsor's protocol ID
- JulesBordetI
- Acronym
- PROCPHGP
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly due to patient confidentiality considerations and institutional data protection policies in accordance with applicable regulations (including GDPR).
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biopsy-Resection Agreement of Peritoneal Histopathological Growth Patterns in Colorectal Peritoneal Metastases: A Prospective Observational Pilot Study
- ClinicalTrials.gov ID
- NCT07474025
- Acronym / sponsor ID
- PROCPHGP / JulesBordetI
- Conditions
- Peritoneal (Metastatic) Cancer, Colorectal Cancer, Colorectal (Colon or Rectal) Cancer, Histopathological Growth Patterns (HGPs)
- Keywords
- Peritoneal cancer, Colorectal cancer, Histopathological Growth Patterns
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 16 Mar 2026 (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.
his prospective, single-center observational pilot study evaluates whether peritoneal histopathological growth patterns can be assessed on limited excisional biopsies obtained during staging laparoscopy in adults with suspected or confirmed colorectal peritoneal metastases. The study primarily evaluates agreement between the dominant histopathological growth pattern identified on laparoscopic biopsy and that identified on subsequent operative specimens.
One to three peritoneal deposits will be sampled during staging laparoscopy. When surgery proceeds, up to three peritoneal deposits will be collected from the operative specimen, preferably from corresponding Peritoneal Cancer Index regions. Two pathologists, blinded to clinical information, specimen timing, and each other's assessments, will independently estimate the proportions of pushing and infiltrating growth patterns.
Histopathological growth pattern findings will not be used to guide clinical management. Biopsy evaluability, interobserver reproducibility, interlesional heterogeneity, and exploratory associations with clinical and surgical characteristics will also be assessed.
Detailed description
Peritoneal histopathological growth patterns (HGPs) describe the morphological interface between metastatic tumor deposits and the surrounding peritoneal tissue and may provide biological information that is not captured by conventional clinical or pathological variables. This prospective, single-center observational pilot study aims to determine whether peritoneal HGPs can be reliably assessed on limited biopsies obtained during staging laparoscopy and whether the dominant HGP identified on these biopsies agrees with that identified on subsequent cytoreductive surgery (CRS) specimens. Thirty adult patients with colorectal peritoneal metastases who are scheduled to undergo both staging laparoscopy and cytoreductive surgery, with or without hyperthermic intraperitoneal chemotherapy, will be prospectively enrolled.
During staging laparoscopy, one to three peritoneal deposits will be sampled using cold scissors. CRS will subsequently be performed within eight weeks, without interval systemic anticancer treatment. During CRS up to three additional peritoneal deposits will be collected, preferably from the same PCI regions or anatomical compartments as the laparoscopic samples. Two pathologists, blinded to clinical information, specimen timing, and each other's assessments, will independently estimate the proportions of pushing and infiltrating HGP at the tumor-peritoneum interface according to a prespecified histopathological standard operating procedure. The primary outcome will be patient-level agreement in dominant HGP classification between staging-laparoscopy biopsies and cytoreductive surgery specimens. Secondary outcomes will include biopsy evaluability, interobserver agreement, agreement in continuous HGP proportions, interlesional heterogeneity, and exploratory associations between HGP and primary-tumor characteristics, PCI, and completeness of cytoreduction. Overall survival and disease-free survival will be explored descriptively; however, the study is not powered to establish the prognostic value or clinical utility of HGP. HGP assessments will not be used to guide treatment decisions, which will remain based on standard multidisciplinary clinical evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with colorectal peritoneal metastases | – | –Adult patients with histologically confirmed colorectal cancer and suspected or confirmed peritoneal metastases undergoing standard-of-care surgical evaluation or treatment (staging laparoscopy and/or cytoreductive surgery ± HIPEC). Peritoneal metastasis tissue samples obtained during routine clinical care are analyzed histologically to assess histological growth patterns and their association with clinical and pathological outcomes. No experimental intervention is performed as part of the study. |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of adult patients with histologically confirmed colorectal cancer and suspected or confirmed peritoneal metastases who undergo surgical evaluation or treatment (staging laparoscopy and/or cytoreductive surgery ± HIPEC) as part of routine clinical care at participating centers. Peritoneal metastasis tissue samples obtained during these procedures are used for histopathological analysis to evaluate histological growth patterns and their association with clinicopathological characteristics and clinical outcomes.
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Histologically confirmed colorectal adenocarcinoma
- Suspected or confirmed peritoneal metastases from colorectal cancer based on imaging or prior clinical evaluation
- Patients undergoing staging laparoscopy and/or cytoreductive surgery (CRS) ± hyperthermic intraperitoneal chemotherapy (HIPEC) as part of standard clinical care
- Availability of peritoneal metastasis tissue samples suitable for histopathological analysis
Key exclusion criteria (5 listed)
- Age < 18 years
- Peritoneal metastases originating from non-colorectal primary tumors
- Absence of available or adequate peritoneal metastasis tissue samples for histological growth pattern analysis
- Patients who decline or withdraw informed consent
- Patients unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concordance of peritoneal histopathological growth pattern classification between staging-laparoscopy biopsies and subsequent cytoreductive surgery specimens.
Time frame: At time of histopathological analysis of surgical or laparoscopic biopsy specimens (baseline, during initial surgical evaluation).
Histological characterization of colorectal peritoneal metastases according to predefined histological growth pattern criteria (e.g., pushing, infiltrative/replacement, or mixed patterns) on hematoxylin and eosin (H\&E)-stained tissue sections obtained from peritoneal biopsies or surgical specimens. The proportion of each HGP type will be determined.
3 secondary outcomes
Association between histological growth patterns and peritoneal disease burden
Time frame: At time of surgery or staging laparoscopy.
Association between histological growth patterns and histopathological tumor characteristics
Time frame: At time of histopathological analysis.
Association between histological growth patterns and survival outcomes
Time frame: Up to 2 years after surgery or diagnosis of peritoneal metastases.
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 26 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly due to patient confidentiality considerations and institutional data protection policies in accordance with applicable regulations (including GDPR).
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal (Metastatic) Cancer and Colorectal Cancer, run by Jules Bordet Institute at 2 sites 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 6 inclusion and 5 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 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 Gabriel Professor Liberale, MD, pHD (+32 2 541 31 11, gabriele.liberale@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance of peritoneal histopathological growth pattern classification between staging-laparoscopy biopsies and subsequent cytoreductive surgery specimens. (time frame: At time of histopathological analysis of surgical or laparoscopic biopsy specimens (baseline, during initial surgical evaluation).). 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 26 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.