Colon CancerNCT02788669
LRP1 and Colon Cancer
An observational study of Colon Cancer and Adenocarcinoma, run by CHU de Reims at 1 site in France.
Trial summary
Colorectal cancer (CRC) is a major public health problem in France and worldwide. CRC is the third most common cancer in incidence and mortality in France. The vast majority of these cancers are adenocarcinomas that arise sporadically and develop from precursor lesions: adenoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Adenocarcinoma
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to May 2017
- 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: Adult patients with sporadic colonic adenocarcinoma treated by surgery at the Academic Hospital of Reims without any neoadjuvant therapy.
Who may be able to join
- patients operated for colon adenocarcinoma infiltrating stage II at least
- operated at Chu Reims between 01/01/2006 and 31/12/2012
- who have given their consent for this study
- did not receive treatment neoadjuvant.
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Reims
Reims, France, 51092
Camille Boulagnon
About this study
Official title: Prognostic Impact of Immunohistochemical and Molecular Expression of the Endocytosis Receptor LRP1 in Colonic Adenocarcinomas
Colorectal cancer (CRC) is a major public health problem in France and worldwide. CRC is the third most common cancer in incidence and mortality in France. The vast majority of these cancers are adenocarcinomas that arise sporadically and develop from precursor lesions: adenoma. All CCR with the same disease stage do not have the same prognosis. Various parameters have been identified as factors influencing the prognosis and allows adjustment of the treatment. The poor histoprognostic factors are vessels and nerves invasion by the tumor or the mucinous adenocarcinoma subtype. At the molecular level, the presence of microsatellite instability (MSI) improves the prognosis, while the presence of a BRAF mutation is an independent poor prognostic factor.
LRP-1 is a multifunctional endocytic receptor that belongs to the family of LDL receptors. It is involved in the clearance of matrix proteases. A loss of expression or a decrease of the LRP-1 activity is correlated with an increase of aggressiveness of cancer cells. This effect was demonstrated in vitro in vesicular thyroid carcinomas after LRP-1 blocking. The decrease in the immunohistochemical expression and LRP-1 genomic in hepatocellular carcinomas and lung adenocarcinomas was correlated with a decrease in the overall survival. In CRC, only one immunohistochemical expression study of LRP-1 in colonic adenocarcinoma has been published to date. This study shows that tumor cells express LRP-1, but in nearly half the cases, weaker than in normal colonic cells. The clinical and prognostic impact of LRP-1 expression in colon cancer and its association with a particular molecular or morphological profile has not been studied to date.
In this work, the investigators will study the immunohistochemical and genic expression of LRP-1 in a series of colorectal cancers.
Read the detailed description
Colorectal cancer (CRC) is a major public health problem in France and worldwide. CRC is the third most common cancer in incidence and mortality in France. The vast majority of these cancers are adenocarcinomas that arise sporadically and develop from precursor lesions: adenoma. All CRC with the same disease stage do not have the same prognosis. Various parameters have been identified as factors influencing the prognosis and allows adjustment of the treatment. The poor histoprognostic factors are the presence of tumor vessels and nerves invasion or the mucinous adenocarcinoma subtype. At the molecular level, the presence of microsatellite instability (MSI) improves the prognosis, while the presence of a BRAF mutation is an independent poor prognostic factor.
Low density lipoprotein related Protein Receptor 1 (LRP-1) is a multifunctional endocytic receptor that belongs to the family of LDL receptors. He is involved in the clearance of enzymes responsible for the degradation of the extracellular matrix: the matrix proteases. This role of matrix proteolysis modulator associated with a function of cell migration regulator give to this protein an anticancer role. The antitumor property of LRP-1 has been demonstrated in thyroid cancers in vitro. In these studies, loss of LRP-1 expression or a decrease in the LRP-1 activity was correlated with an increase of cancer cells migration and invasion. However, the opposite effect was observed in prostate cancer cell lines.
The clinical impact of the level of LRP-1 expression on overall survival of cancer patients has been assessed in two studies: one on patients suffering from hepatocellular carcinoma and one on patients suffering from primitive lung adenocarcinomas. In both studies, the decrease of immunohistochemical and gene expression of LRP-1 correlated with overall survival decrease. In CRC, only one immunohistochemical expression study of LRP-1 has been published to date. This study shows that adenocarcinomatous cells express LRP-1, but in nearly half the cases, weaker than in normal colonic cells. The clinical and prognostic impact of LRP-1 expression in colon cancer and its association with a particular molecular or morphological profile has not been studied to date.
In this work, the investigators will study the immunohistochemical and genic expression of LRP-1 in a well-characterized series of CRC.
The main objective of this study is to study by genic and immunohistochemical approaches the role of LRP-1 in the aggressiveness of colon adenocarcinomas.
The secondary objective of this study is to search for associations between LRP-1 expression level and morphological or molecular profiles of colonic adenocarcinomas
This study will be the first to explore the expression of LRP-1 in well characterized colon cancers of different morphological and molecular profiles. This study will help to increase knowledge of the prognostic role of LRP-1 in colon cancer and its possible association with clinical, morphological or molecular parameters.
There will be a retrospective cohort study, single center.
The investigators will first design the list of all eligible patients by using a request in the software DIAMIC of th pathology department with component code "colon", damage code "adenocarcinoma " and period "between 2006 and 2012". Patients suffering from Lynch syndrome or other familial cancer syndrome will be excluded of the study. Informed consent will be send to all the selected patients.
Once the patients list will be completed:
- The patients' medical records will be reviewed for: sociodemographic and clinical data colonic tumor location, presence of synchronous metastases, treatment type and duration, patient follow up to the date of 01/06/2014 point (metastases occurrence, disease recurrence, patient death, ...).
- A central review of all pathological slides will be performed for these criteria: adenocarcinoma subtype according to WHO 2010 classification, differentiation, association with polyps and their types, pTNM stage, invasion front and budding, stroma type, presence and amount of tumor necrosis).
- Immunohistochemical analysis on formalin fixed and paraffin embedded tissue will be performed:
- qualitative and semi-quantitative evaluation of LRP1 immunoexpression with anti-5A6 and 8G1 antibodies
- RER phenotype research (MLH1, MSH2, MSH6 and PMS2 immunohistochemistry) and BRAF V600E immunohistochemistry
- Molecular analyzes:
- analysis of LRP-1 gene expression on frozen tissue
- for selected cases: search for microsatellite instability, search for BRAF V600E, KRAS (exon 2, 3 and 4) and NRAS (exons 2, 3 and 4) mutation on formalin fixed and paraffin embedded tissue
Statistical analysis:
- Data description: mean and standard deviation for quantitative variables; number and percentage for categorical variables.
- Comparison of tumors having a high expression of LRP-1 and tumors not or little expressing LRP-1 by univariate analysis (Student's test and the Wilcoxon test, Chi2 or Fisher's exact) and multivariate (logistic regression).
- Search factors associated with patient outcomes, including the expression of LRP1, by univariate analysis (log-rank test) and multivariate (Cox model).
Colorectal cancer (CRC) is a major public health problem in France and worldwide. CRC is the third most common cancer in incidence and mortality in France. The vast majority of these cancers are adenocarcinomas that arise sporadically and develop from precursor lesions: adenoma. All CRC with the same disease stage do not have the same prognosis. Various parameters have been identified as factors influencing the prognosis and allows adjustment of the treatment. The poor histoprognostic factors are the presence of tumor vessels and nerves invasion or the mucinous adenocarcinoma subtype. At the molecular level, the presence of microsatellite instability (MSI) improves the prognosis, while the presence of a BRAF mutation is an independent poor prognostic factor.
Low density lipoprotein related Protein Receptor 1 (LRP-1) is a multifunctional endocytic receptor that belongs to the family of LDL receptors. He is involved in the clearance of enzymes responsible for the degradation of the extracellular matrix: the matrix proteases. This role of matrix proteolysis modulator associated with a function of cell migration regulator give to this protein an anticancer role. The antitumor property of LRP-1 has been demonstrated in thyroid cancers in vitro. In these studies, loss of LRP-1 expression or a decrease in the LRP-1 activity was correlated with an increase of cancer cells migration and invasion. However, the opposite effect was observed in prostate cancer cell lines.
The clinical impact of the level of LRP-1 expression on overall survival of cancer patients has been assessed in two studies: one on patients suffering from hepatocellular carcinoma and one on patients suffering from primitive lung adenocarcinomas. In both studies, the decrease of immunohistochemical and gene expression of LRP-1 correlated with overall survival decrease. In CRC, only one immunohistochemical expression study of LRP-1 has been published to date. This study shows that adenocarcinomatous cells express LRP-1, but in nearly half the cases, weaker than in normal colonic cells. The clinical and prognostic impact of LRP-1 expression in colon cancer and its association with a particular molecular or morphological profile has not been studied to date.
In this work, the investigators will study the immunohistochemical and genic expression of LRP-1 in a well-characterized series of CRC.
The main objective of this study is to study by genic and immunohistochemical approaches the role of LRP-1 in the aggressiveness of colon adenocarcinomas.
The secondary objective of this study is to search for associations between LRP-1 expression level and morphological or molecular profiles of colonic adenocarcinomas
This study will be the first to explore the expression of LRP-1 in well characterized colon cancers of different morphological and molecular profiles. This study will help to increase knowledge of the prognostic role of LRP-1 in colon cancer and its possible association with clinical, morphological or molecular parameters.
There will be a retrospective cohort study, single center.
The investigators will first design the list of all eligible patients by using a request in the software DIAMIC of th pathology department with component code "colon", damage code "adenocarcinoma " and period "between 2006 and 2012". Patients suffering from Lynch syndrome or other familial cancer syndrome will be excluded of the study. Informed consent will be send to all the selected patients.
Once the patients list will be completed:
- The patients' medical records will be reviewed for: sociodemographic and clinical data colonic tumor location, presence of synchronous metastases, treatment type and duration, patient follow up to the date of 01/06/2014 point (metastases occurrence, disease recurrence, patient death, ...).
- A central review of all pathological slides will be performed for these criteria: adenocarcinoma subtype according to WHO 2010 classification, differentiation, association with polyps and their types, pTNM stage, invasion front and budding, stroma type, presence and amount of tumor necrosis).
- Immunohistochemical analysis on formalin fixed and paraffin embedded tissue will be performed:
- qualitative and semi-quantitative evaluation of LRP1 immunoexpression with anti-5A6 and 8G1 antibodies
- RER phenotype research (MLH1, MSH2, MSH6 and PMS2 immunohistochemistry) and BRAF V600E immunohistochemistry
- Molecular analyzes:
- analysis of LRP-1 gene expression on frozen tissue
- for selected cases: search for microsatellite instability, search for BRAF V600E, KRAS (exon 2, 3 and 4) and NRAS (exons 2, 3 and 4) mutation on formalin fixed and paraffin embedded tissue
Statistical analysis:
- Data description: mean and standard deviation for quantitative variables; number and percentage for categorical variables.
- Comparison of tumors having a high expression of LRP-1 and tumors not or little expressing LRP-1 by univariate analysis (Student's test and the Wilcoxon test, Chi2 or Fisher's exact) and multivariate (logistic regression).
- Search factors associated with patient outcomes, including the expression of LRP1, by univariate analysis (log-rank test) and multivariate (Cox model).
- Conditions
- Colon Cancer, Adenocarcinoma
- Medical subject headings
- Colonic Neoplasms, Adenocarcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
LRP1 molecular expression
Measured: between 2006 and 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startNov 2015
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788669
- Sponsor's protocol ID
- PO15124
- Status last verified
- May 2016
- First submitted
- 20 May 2016
- Last updated
- 2 Jun 2016
- Results posted
- No
Publications
Galissier T, Schneider C, Nasri S, Kanagaratnam L, Fichel C, Coquelet C, Diebold MD, Kianmanesh R, Bellon G, Dedieu S, Marchal Bressenot A, Boulagnon-Rombi C. Biobanking of Fresh-Frozen Human Adenocarcinomatous and Normal Colon Tissues: Which Parameters Influence RNA Quality? PLoS One. 2016 Apr 28;11(4):e0154326. doi: 10.1371/journal.pone.0154326. eCollection 2016.
PubMed 27124490
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Impact of Immunohistochemical and Molecular Expression of the Endocytosis Receptor LRP1 in Colonic Adenocarcinomas
- ClinicalTrials.gov ID
- NCT02788669
- Acronym / sponsor ID
- PO15124
- Conditions
- Colon Cancer, Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 2 Jun 2016 (estimated)
- 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.
Colorectal cancer (CRC) is a major public health problem in France and worldwide. CRC is the third most common cancer in incidence and mortality in France. The vast majority of these cancers are adenocarcinomas that arise sporadically and develop from precursor lesions: adenoma. All CCR with the same disease stage do not have the same prognosis. Various parameters have been identified as factors influencing the prognosis and allows adjustment of the treatment. The poor histoprognostic factors are vessels and nerves invasion by the tumor or the mucinous adenocarcinoma subtype. At the molecular level, the presence of microsatellite instability (MSI) improves the prognosis, while the presence of a BRAF mutation is an independent poor prognostic factor.
LRP-1 is a multifunctional endocytic receptor that belongs to the family of LDL receptors. It is involved in the clearance of matrix proteases. A loss of expression or a decrease of the LRP-1 activity is correlated with an increase of aggressiveness of cancer cells. This effect was demonstrated in vitro in vesicular thyroid carcinomas after LRP-1 blocking. The decrease in the immunohistochemical expression and LRP-1 genomic in hepatocellular carcinomas and lung adenocarcinomas was correlated with a decrease in the overall survival. In CRC, only one immunohistochemical expression study of LRP-1 in colonic adenocarcinoma has been published to date. This study shows that tumor cells express LRP-1, but in nearly half the cases, weaker than in normal colonic cells. The clinical and prognostic impact of LRP-1 expression in colon cancer and its association with a particular molecular or morphological profile has not been studied to date.
In this work, the investigators will study the immunohistochemical and genic expression of LRP-1 in a series of colorectal cancers.
Detailed description
Colorectal cancer (CRC) is a major public health problem in France and worldwide. CRC is the third most common cancer in incidence and mortality in France. The vast majority of these cancers are adenocarcinomas that arise sporadically and develop from precursor lesions: adenoma. All CRC with the same disease stage do not have the same prognosis. Various parameters have been identified as factors influencing the prognosis and allows adjustment of the treatment. The poor histoprognostic factors are the presence of tumor vessels and nerves invasion or the mucinous adenocarcinoma subtype. At the molecular level, the presence of microsatellite instability (MSI) improves the prognosis, while the presence of a BRAF mutation is an independent poor prognostic factor.
Low density lipoprotein related Protein Receptor 1 (LRP-1) is a multifunctional endocytic receptor that belongs to the family of LDL receptors. He is involved in the clearance of enzymes responsible for the degradation of the extracellular matrix: the matrix proteases. This role of matrix proteolysis modulator associated with a function of cell migration regulator give to this protein an anticancer role. The antitumor property of LRP-1 has been demonstrated in thyroid cancers in vitro. In these studies, loss of LRP-1 expression or a decrease in the LRP-1 activity was correlated with an increase of cancer cells migration and invasion. However, the opposite effect was observed in prostate cancer cell lines.
The clinical impact of the level of LRP-1 expression on overall survival of cancer patients has been assessed in two studies: one on patients suffering from hepatocellular carcinoma and one on patients suffering from primitive lung adenocarcinomas. In both studies, the decrease of immunohistochemical and gene expression of LRP-1 correlated with overall survival decrease. In CRC, only one immunohistochemical expression study of LRP-1 has been published to date. This study shows that adenocarcinomatous cells express LRP-1, but in nearly half the cases, weaker than in normal colonic cells. The clinical and prognostic impact of LRP-1 expression in colon cancer and its association with a particular molecular or morphological profile has not been studied to date.
In this work, the investigators will study the immunohistochemical and genic expression of LRP-1 in a well-characterized series of CRC.
The main objective of this study is to study by genic and immunohistochemical approaches the role of LRP-1 in the aggressiveness of colon adenocarcinomas.
The secondary objective of this study is to search for associations between LRP-1 expression level and morphological or molecular profiles of colonic adenocarcinomas
This study will be the first to explore the expression of LRP-1 in well characterized colon cancers of different morphological and molecular profiles. This study will help to increase knowledge of the prognostic role of LRP-1 in colon cancer and its possible association with clinical, morphological or molecular parameters.
There will be a retrospective cohort study, single center.
The investigators will first design the list of all eligible patients by using a request in the software DIAMIC of th pathology department with component code "colon", damage code "adenocarcinoma " and period "between 2006 and 2012". Patients suffering from Lynch syndrome or other familial cancer syndrome will be excluded of the study. Informed consent will be send to all the selected patients.
Once the patients list will be completed:
- The patients' medical records will be reviewed for: sociodemographic and clinical data colonic tumor location, presence of synchronous metastases, treatment type and duration, patient follow up to the date of 01/06/2014 point (metastases occurrence, disease recurrence, patient death, ...).
- A central review of all pathological slides will be performed for these criteria: adenocarcinoma subtype according to WHO 2010 classification, differentiation, association with polyps and their types, pTNM stage, invasion front and budding, stroma type, presence and amount of tumor necrosis).
- Immunohistochemical analysis on formalin fixed and paraffin embedded tissue will be performed:
- qualitative and semi-quantitative evaluation of LRP1 immunoexpression with anti-5A6 and 8G1 antibodies
- RER phenotype research (MLH1, MSH2, MSH6 and PMS2 immunohistochemistry) and BRAF V600E immunohistochemistry
- Molecular analyzes:
- analysis of LRP-1 gene expression on frozen tissue
- for selected cases: search for microsatellite instability, search for BRAF V600E, KRAS (exon 2, 3 and 4) and NRAS (exons 2, 3 and 4) mutation on formalin fixed and paraffin embedded tissue
Statistical analysis:
- Data description: mean and standard deviation for quantitative variables; number and percentage for categorical variables.
- Comparison of tumors having a high expression of LRP-1 and tumors not or little expressing LRP-1 by univariate analysis (Student's test and the Wilcoxon test, Chi2 or Fisher's exact) and multivariate (logistic regression).
- Search factors associated with patient outcomes, including the expression of LRP1, by univariate analysis (log-rank test) and multivariate (Cox model).
Colorectal cancer (CRC) is a major public health problem in France and worldwide. CRC is the third most common cancer in incidence and mortality in France. The vast majority of these cancers are adenocarcinomas that arise sporadically and develop from precursor lesions: adenoma. All CRC with the same disease stage do not have the same prognosis. Various parameters have been identified as factors influencing the prognosis and allows adjustment of the treatment. The poor histoprognostic factors are the presence of tumor vessels and nerves invasion or the mucinous adenocarcinoma subtype. At the molecular level, the presence of microsatellite instability (MSI) improves the prognosis, while the presence of a BRAF mutation is an independent poor prognostic factor.
Low density lipoprotein related Protein Receptor 1 (LRP-1) is a multifunctional endocytic receptor that belongs to the family of LDL receptors. He is involved in the clearance of enzymes responsible for the degradation of the extracellular matrix: the matrix proteases. This role of matrix proteolysis modulator associated with a function of cell migration regulator give to this protein an anticancer role. The antitumor property of LRP-1 has been demonstrated in thyroid cancers in vitro. In these studies, loss of LRP-1 expression or a decrease in the LRP-1 activity was correlated with an increase of cancer cells migration and invasion. However, the opposite effect was observed in prostate cancer cell lines.
The clinical impact of the level of LRP-1 expression on overall survival of cancer patients has been assessed in two studies: one on patients suffering from hepatocellular carcinoma and one on patients suffering from primitive lung adenocarcinomas. In both studies, the decrease of immunohistochemical and gene expression of LRP-1 correlated with overall survival decrease. In CRC, only one immunohistochemical expression study of LRP-1 has been published to date. This study shows that adenocarcinomatous cells express LRP-1, but in nearly half the cases, weaker than in normal colonic cells. The clinical and prognostic impact of LRP-1 expression in colon cancer and its association with a particular molecular or morphological profile has not been studied to date.
In this work, the investigators will study the immunohistochemical and genic expression of LRP-1 in a well-characterized series of CRC.
The main objective of this study is to study by genic and immunohistochemical approaches the role of LRP-1 in the aggressiveness of colon adenocarcinomas.
The secondary objective of this study is to search for associations between LRP-1 expression level and morphological or molecular profiles of colonic adenocarcinomas
This study will be the first to explore the expression of LRP-1 in well characterized colon cancers of different morphological and molecular profiles. This study will help to increase knowledge of the prognostic role of LRP-1 in colon cancer and its possible association with clinical, morphological or molecular parameters.
There will be a retrospective cohort study, single center.
The investigators will first design the list of all eligible patients by using a request in the software DIAMIC of th pathology department with component code "colon", damage code "adenocarcinoma " and period "between 2006 and 2012". Patients suffering from Lynch syndrome or other familial cancer syndrome will be excluded of the study. Informed consent will be send to all the selected patients.
Once the patients list will be completed:
- The patients' medical records will be reviewed for: sociodemographic and clinical data colonic tumor location, presence of synchronous metastases, treatment type and duration, patient follow up to the date of 01/06/2014 point (metastases occurrence, disease recurrence, patient death, ...).
- A central review of all pathological slides will be performed for these criteria: adenocarcinoma subtype according to WHO 2010 classification, differentiation, association with polyps and their types, pTNM stage, invasion front and budding, stroma type, presence and amount of tumor necrosis).
- Immunohistochemical analysis on formalin fixed and paraffin embedded tissue will be performed:
- qualitative and semi-quantitative evaluation of LRP1 immunoexpression with anti-5A6 and 8G1 antibodies
- RER phenotype research (MLH1, MSH2, MSH6 and PMS2 immunohistochemistry) and BRAF V600E immunohistochemistry
- Molecular analyzes:
- analysis of LRP-1 gene expression on frozen tissue
- for selected cases: search for microsatellite instability, search for BRAF V600E, KRAS (exon 2, 3 and 4) and NRAS (exons 2, 3 and 4) mutation on formalin fixed and paraffin embedded tissue
Statistical analysis:
- Data description: mean and standard deviation for quantitative variables; number and percentage for categorical variables.
- Comparison of tumors having a high expression of LRP-1 and tumors not or little expressing LRP-1 by univariate analysis (Student's test and the Wilcoxon test, Chi2 or Fisher's exact) and multivariate (logistic regression).
- Search factors associated with patient outcomes, including the expression of LRP1, by univariate analysis (log-rank test) and multivariate (Cox model).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with sporadic colonic adenocarcinoma treated by surgery at the Academic Hospital of Reims without any neoadjuvant therapy.
Key inclusion criteria (4 listed)
- patients operated for colon adenocarcinoma infiltrating stage II at least
- operated at Chu Reims between 01/01/2006 and 31/12/2012
- who have given their consent for this study
- did not receive treatment neoadjuvant.
Key exclusion criteria (1 listed)
- NA
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
LRP1 molecular expression
Time frame: between 2006 and 2012
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2016.
- Background: PubMed 27124490Galissier T, Schneider C, Nasri S, Kanagaratnam L, Fichel C, Coquelet C, Diebold MD, Kianmanesh R, Bellon G, Dedieu S, Marchal Bressenot A, Boulagnon-Rombi C. Biobanking of Fresh-Frozen Human Adenocarcinomatous and Normal Colon Tissues: Which Parameters Influence RNA Quality? PLoS One. 2016 Apr 28;11(4):e0154326. doi: 10.1371/journal.pone.0154326. eCollection 2016.
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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.
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 Colon Cancer and Adenocarcinoma, run by CHU de Reims 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 4 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 2 Jun 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Camille Boulagnon (326784218 ext. 33, cboulagnon@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LRP1 molecular expression (time frame: between 2006 and 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02788669, which also lists 1 linked publication.
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 2 Jun 2016.