Breast CancerBreastIlsNCT03667612
Endogenous Mechanisms of Inactivation of the Endothelium Tumor
An observational study of Breast Cancer and Colon Cancer, run by Centre Oscar Lambret at 2 sites in France.
Trial summary
The role of immunity in the development of cancers, and the associated escape mechanisms, have attracted renewed interest since the publication of tests testing immunological checkpoint inhibitors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colon Cancer
- How many people
- 70 participants
- Where
- 2 sitesFrance
- Study dates
- 31 Jan 2018to 31 Oct 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with: * a breast cancer * a colorectal cancer
Who may be able to join
- Men and women aged 18 and over
- Confirmed histological diagnosis of breast carcinoma at localized or metastatic stage or colorectal cancer
- Treated at the Oscar Lambret Center or the Henri Becquerel Center between 1/1/2005 and 31/12/2007
- Having undergone surgery for excision of the primary tumor and / or a metastasis
- resected specimen available
- Patients who gave their consent
Who cannot join
- History of other cancers
- Breast or colic tumors with other histological profiles
- Patient treated for breast or colonic recurrence
Trial locations and contacts
2 sites in 1 country.
About this study
The role of immunity in the development of cancers, and the associated escape mechanisms, have attracted renewed interest since the publication of tests testing immunological checkpoint inhibitors. One of the steps in the probably least studied immunological response is the penetration of immunocompetent cells within the tumor across the vascular barrier. This infiltration is suggested as a prognostic and predictive marker of treatment response, particularly in triple negative HER2 (Human Epidermal Growth Factor Receptor-2) overexpressing breast cancers. The methods of evaluating these infiltrates are complex and have been the subject of recommendations.
A better understanding of the mechanisms of infiltration of immunity cells within tumors will certainly help to better understand the impact of cancer treatments and develop new therapeutic strategies.
Read more
It is this issue of vascular endothelium that Dr. Soncin's team is developing as part of an INCa (Institut National du cancer) project. The egfl7 / VE-statin (vascular endothelial-statin) gene is thought to be involved in transendothelial passage of immune cells from vascular lumen to tumor. Its expression has already been studied in a series of breast cancers. Other markers of endothelial activation are currently being identified.
The main objective of this project will be to better understand the behavior of the endothelium in a population of breast cancer where the infiltrate in immune cells is precisely likely to play a leading role. This retrospective cohort of 250 to 300 cases treated with adjuvant and neoadjuvant will be immunologically characterized using the recommendations of Salgado et al. that a multicentric team of pathologists will take ownership. This evaluation will be counter-appraised.
Once our cohort is immunologically characterized, our project will focus on better understanding the endothelial mechanisms involved: which cells? immunophenotyping of immunity cells. By which vessels? (measurement of densities in blood and lymphatic vessels, density in HEV). By what mechanisms? Do the actors identified in vitro within the Inca project have an in vivo translation
Read the detailed description
The main objective of this project will be to better understand the behavior of the endothelium in a population of breast cancer where the infiltrate in immune cells is precisely likely to play a leading role. This retrospective cohort of 250 to 300 cases treated with adjuvant and neoadjuvant will be immunologically characterized using the recommendations of Salgado et al., that a multicentric team of pathologists will take ownership. This evaluation will be counter-appraised.
Once our cohort is immunologically characterized, our project will focus on better understanding the endothelial mechanisms involved: which cells? immunophenotyping of immunity cells. By which vessels? (measurement of densities in blood and lymphatic vessels, density in HEV). By what mechanisms? Do the actors identified in vitro within the Inca project have an in vivo translation
- Conditions
- Breast Cancer, Colon Cancer
- Medical subject headings
- Breast 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 breast cancer | * Patients clinical data collection * Selection of patients tumor samples and centralization at the Oscar Lambret and the Henri Becquerel centres * Realization of tumor samples series of cuts and paraffin shavings for: * Quantitative RT-PCR (Reverse Transcription PCR): Assessment of the expression of the genes regulating the endothelium activation: egfl7, SetD5 (SET Domain Containing 5), other genes and microRNAs identified in the high-throughput screen realized by the Dr. F Soncin * Semi-quantitative evaluation of the same genes expression by in situ hybridization techniques (if probes available) * Semi-quantitative evaluation of the expression of the corresponding proteins by immunohistochemistry techniques (If antibodies available) * Characterization of lymphocyte populations * Measurement of the endothelial cell density, the lymphatic endothelium and the "High Endothelial Venules" | |
| Patients with colorectal cancer | * Patients clinical data collection * Selection of patients tumor samples and centralization at the Oscar Lambret Center and the Henri Becquerel Center by the teams of Dr. Yves-Marie Robin and Jean-Michel Picquenot, Head of the Anatomy and Cytopathology Departments * Realization of series of cuts and paraffin shavings of the tumor samples for: * Quantitative RT-PCR: Assessment of the expression of the genes regulating the endothelium activation: egfl7, SetD5, other genes and microRNAs identified in the high-throughput screen realized by the Dr. F Soncin * Semi-quantitative evaluation of the same genes expression by in situ hybridization techniques (if probes are available) * Semi-quantitative evaluation of the expression of the corresponding proteins by immunohistochemistry techniques (If antibodies are available) * Characterization of lymphocyte populations * Measurement of the endothelial cell density, the lymphatic endothelium and the "High Endothelial Venules" |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between the expression levels of the genes involved in the regulation of endothelial activation and the degree of tumor-infiltrating lymphocytes
The expression of the genes (egfl7, SetD5, other genes and microRNAs) will be evaluated quantitatively by RT-PCR. The amount of RNA obtained corresponds to a relative amount of RNA relative to the amount of RNA measured in a sample used as a reference.
A semi-quantitative evaluation will also be carried out by in situ hybridization techniques and immunohistochemistry of endothelial expression of endothelial activation regulation markers: 0+ no labeled vessels, 1+ <30% of labeled vessels, 2+ between 30 and 60% of marked vessels, 3+> 60% of marked vessels The lymphocyte infiltration will be evaluated by measuring the ratio between the surface infiltrated by mononuclear cells and the tumor surface (for intratumoral TILS) or stromal (for total stromal TILS). The analysis will be done on H \& E slides and the data will be expressed as a percentage.
Measured: 24 months
Secondary outcomes (10)
reproducibility of lymphocyte infiltration assessment on H & E slides
Measured: 24 months
study of the subgroups of the cohort with a predominant lymphocytes infiltration cancer
description of subpopulations of immunocompetent cells by specific complementary immunolabeling of CD4 + T lymphocytes (mature T helper lymphocytes expressing the surface protein CD4), cytotoxic CD8 (T lymphocytes expressing the surface protein CD8), T-regulatory (CD25 / FoxP3), B-cell lymphocytes , macrophages and NK (Natural Killer) cells
Measured: 24 months
Cell density description
Description of density in vascular endothelial (CD31 / 34 labeled), lymphatic (LYVE / podoplanin-labeled) and HEV (High endothelial venom MECA79 + (Rat Monoclonal Anti-Peripheral Node Addressin Antibody )) cells and correlation with lymphocyte infiltrate levels
Measured: 24 months
Prognostic value assessment
Evaluate the prognostic value of biomarkers and lymphocytic infiltrate in terms of Global Survival and Survival Without Recurrence
Measured: 24 months
Expression levels of genes involved in the regulation of endothelial activation
In subpopulations of patients treated in neo-adjuvant or metastatic situations: assess the expression levels of genes involved in the regulation of endothelial activation
Measured: 24 months
treatment response data
In subpopulations of patients treated in neo-adjuvant or metastatic situations: assess the treatment response data (chemotherapy in patients with breast cancer, chemotherapy and antiangiogenic in colon cancers)
Measured: 24 months
lymphocytic infiltrate data
For patients treated for breast cancer: study lymphocytic infiltrate data
Measured: 24 months
the existence of a BRCA1 and or BRCA 2 mutation (which are tumour suppressor genes)
For patients treated for breast cancer: assess the existence of a BRCA1 and or BRCA 2 mutation
Measured: 24 months
association between lymphocytic infiltrate data and the RER phenotype (the replication error phenotype)
For patients treated for colon cancer: to study the association between lymphocytic infiltrate data and the RER phenotype
Measured: 24 months
The RER phenotype (the replication error phenotype)
For patients treated for colon cancer: to study the RER phenotype
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 posted12 Sep 2018
- Study start31 Jan 2018
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Biologie de Lille
- Responsible party
- Sponsor
- Investigators
- Géraldine Lauridant, MD, Principal investigator, Centre oscar Lambret de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667612
- Sponsor's protocol ID
- BreastIls-1605
- Acronym
- BreastIls
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2018
- Last updated
- 16 Sep 2026
- 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endogenous Mechanisms of Inactivation of the Endothelium Tumor
- ClinicalTrials.gov ID
- NCT03667612
- Acronym / sponsor ID
- BreastIls / BreastIls-1605
- Conditions
- Breast Cancer, Colon Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- Institut de Biologie de Lille
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 12 Sep 2018 (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.
The role of immunity in the development of cancers, and the associated escape mechanisms, have attracted renewed interest since the publication of tests testing immunological checkpoint inhibitors. One of the steps in the probably least studied immunological response is the penetration of immunocompetent cells within the tumor across the vascular barrier. This infiltration is suggested as a prognostic and predictive marker of treatment response, particularly in triple negative HER2 (Human Epidermal Growth Factor Receptor-2) overexpressing breast cancers. The methods of evaluating these infiltrates are complex and have been the subject of recommendations.
A better understanding of the mechanisms of infiltration of immunity cells within tumors will certainly help to better understand the impact of cancer treatments and develop new therapeutic strategies.
It is this issue of vascular endothelium that Dr. Soncin's team is developing as part of an INCa (Institut National du cancer) project. The egfl7 / VE-statin (vascular endothelial-statin) gene is thought to be involved in transendothelial passage of immune cells from vascular lumen to tumor. Its expression has already been studied in a series of breast cancers. Other markers of endothelial activation are currently being identified.
The main objective of this project will be to better understand the behavior of the endothelium in a population of breast cancer where the infiltrate in immune cells is precisely likely to play a leading role. This retrospective cohort of 250 to 300 cases treated with adjuvant and neoadjuvant will be immunologically characterized using the recommendations of Salgado et al. that a multicentric team of pathologists will take ownership. This evaluation will be counter-appraised.
Once our cohort is immunologically characterized, our project will focus on better understanding the endothelial mechanisms involved: which cells? immunophenotyping of immunity cells. By which vessels? (measurement of densities in blood and lymphatic vessels, density in HEV). By what mechanisms? Do the actors identified in vitro within the Inca project have an in vivo translation
Detailed description
The main objective of this project will be to better understand the behavior of the endothelium in a population of breast cancer where the infiltrate in immune cells is precisely likely to play a leading role. This retrospective cohort of 250 to 300 cases treated with adjuvant and neoadjuvant will be immunologically characterized using the recommendations of Salgado et al., that a multicentric team of pathologists will take ownership. This evaluation will be counter-appraised.
Once our cohort is immunologically characterized, our project will focus on better understanding the endothelial mechanisms involved: which cells? immunophenotyping of immunity cells. By which vessels? (measurement of densities in blood and lymphatic vessels, density in HEV). By what mechanisms? Do the actors identified in vitro within the Inca project have an in vivo translation
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with breast cancer | – | –* Patients clinical data collection * Selection of patients tumor samples and centralization at the Oscar Lambret and the Henri Becquerel centres * Realization of tumor samples series of cuts and paraffin shavings for: * Quantitative RT-PCR (Reverse Transcription PCR): Assessment of the expression of the genes regulating the endothelium activation: egfl7, SetD5 (SET Domain Containing 5), other genes and microRNAs identified in the high-throughput screen realized by the Dr. F Soncin * Semi-quantitative evaluation of the same genes expression by in situ hybridization techniques (if probes available) * Semi-quantitative evaluation of the expression of the corresponding proteins by immunohistochemistry techniques (If antibodies available) * Characterization of lymphocyte populations * Measurement of the endothelial cell density, the lymphatic endothelium and the "High Endothelial Venules" |
| Patients with colorectal cancer | – | –* Patients clinical data collection * Selection of patients tumor samples and centralization at the Oscar Lambret Center and the Henri Becquerel Center by the teams of Dr. Yves-Marie Robin and Jean-Michel Picquenot, Head of the Anatomy and Cytopathology Departments * Realization of series of cuts and paraffin shavings of the tumor samples for: * Quantitative RT-PCR: Assessment of the expression of the genes regulating the endothelium activation: egfl7, SetD5, other genes and microRNAs identified in the high-throughput screen realized by the Dr. F Soncin * Semi-quantitative evaluation of the same genes expression by in situ hybridization techniques (if probes are available) * Semi-quantitative evaluation of the expression of the corresponding proteins by immunohistochemistry techniques (If antibodies are available) * Characterization of lymphocyte populations * Measurement of the endothelial cell density, the lymphatic endothelium and the "High Endothelial Venules" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with: * a breast cancer * a colorectal cancer
Key inclusion criteria (6 listed)
- Men and women aged 18 and over
- Confirmed histological diagnosis of breast carcinoma at localized or metastatic stage or colorectal cancer
- Treated at the Oscar Lambret Center or the Henri Becquerel Center between 1/1/2005 and 31/12/2007
- Having undergone surgery for excision of the primary tumor and / or a metastasis
- resected specimen available
Key exclusion criteria (3 listed)
- History of other cancers
- Breast or colic tumors with other histological profiles
- Patient treated for breast or colonic recurrence
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
correlation between the expression levels of the genes involved in the regulation of endothelial activation and the degree of tumor-infiltrating lymphocytes
Time frame: 24 months
The expression of the genes (egfl7, SetD5, other genes and microRNAs) will be evaluated quantitatively by RT-PCR. The amount of RNA obtained corresponds to a relative amount of RNA relative to the amount of RNA measured in a sample used as a reference. A semi-quantitative evaluation will also be carried out by in situ hybridization techniques and immunohistochemistry of endothelial expression of endothelial activation regulation markers: 0+ no labeled vessels, 1+ <30% of labeled vessels, 2+ between 30 and 60% of marked vessels, 3+> 60% of marked vessels The lymphocyte infiltration will be evaluated by measuring the ratio between the surface infiltrated by mononuclear cells and the tumor surface (for intratumoral TILS) or stromal (for total stromal TILS). The analysis will be done on H \& E slides and the data will be expressed as a percentage.
10 secondary outcomes
reproducibility of lymphocyte infiltration assessment on H & E slides
Time frame: 24 months
study of the subgroups of the cohort with a predominant lymphocytes infiltration cancer
Time frame: 24 months
Cell density description
Time frame: 24 months
Prognostic value assessment
Time frame: 24 months
Expression levels of genes involved in the regulation of endothelial activation
Time frame: 24 months
treatment response data
Time frame: 24 months
lymphocytic infiltrate data
Time frame: 24 months
the existence of a BRCA1 and or BRCA 2 mutation (which are tumour suppressor genes)
Time frame: 24 months
association between lymphocytic infiltrate data and the RER phenotype (the replication error phenotype)
Time frame: 24 months
The RER phenotype (the replication error phenotype)
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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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.
Géraldine Lauridant, MD principal investigator
Centre oscar Lambret de Lille
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 Breast Cancer and Colon Cancer, run by Centre Oscar Lambret at 2 sites 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 16 Sep 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between the expression levels of the genes involved in the regulation of endothelial activation and the degree of tumor-infiltrating lymphocytes (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 16 Sep 2026.