Colorectal AdenocarcinomaExhauCRFNCT03149523
Exhaustive Genetic and Immunological Characterization of Colon, Kidney and Liver Tumors
An observational study of Colorectal Adenocarcinoma and Hepatic Carcinoma, run by European Georges Pompidou Hospital at 3 sites in France.
Trial summary
Over the last 10 years, technological advances in molecular biology enabled a more accurate genomic characterization of tumors. For each tumor location, this led to the identification of subgroups with similar molecular characteristics. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Adenocarcinoma, Hepatic Carcinoma, Kidney Adenocarcinoma
- How many people
- 150 participants
- Where
- 3 sitesFrance
- Study dates
- May 2017to Apr 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with colorectal, kidney or liver cancers.
Who may be able to join
- for colorectal cancer group : patient with stage III colon carcinoma
- for kidney cancer group : patient with primary clear cell carcinoma more than 4 cm
- for liver cancer group : patient with advanced hepatocellular carcinoma : biopsy or resected BCLC (Barcelona Clinic Liver Cancer) stage B or C
- patients who have consented to the study
Who cannot join
- Patients receiving neoadjuvant therapy are not eligible
Trial locations and contacts
3 sites in 1 country.
Eric Tartour, MD, PhD contact
France3 sites
AP-HP Jean Verdier Hospital
Bondy, 93140
Jean-Charles Nault, MD, jean-charles.nault@aphp.fr
Jessica Zucman-Rossi, MD, PhD
AP-HP Cochin Hospital
Paris, 75014
Michael Peyromaure, MD, PhD, michael.peyromaure@aphp.fr
Jérôme Alexandre, MD, PhD, jerome.alexandre@aphp.fr
AP-HP European Georges Pompidou Hospital
Paris, 75015
Pierre Laurent-Puig, MD, PhD, pierre.laurent-puig@parisdescartes.fr
Eric Tartour, MD, PhD, eric.tartour@aphp.fr
About this study
Official title: Exhaustive Genetic and Immunological Characterization of Colon, Kidney and Liver Tumors to Define Potential Targets of Targeted and/or Immunomodulatory Therapies
Over the last 10 years, technological advances in molecular biology enabled a more accurate genomic characterization of tumors. For each tumor location, this led to the identification of subgroups with similar molecular characteristics. This identification allowed the development of targeted therapies and thus to improve the patient prognosis. This molecular characterization has also revealed the tumor heterogeneity. It may be the cause of treatment resistance and therefore of relapses. Additionally, tumor cells are in constant dialogue with their microenvironment composed of different immune or non immune cells. This microenvironment is now targeted in cancer treatment.
To date, there are few studies that combine a deep genomic characterization of both tumor and tumor microenvironment of the patient. Combining the two types of studies on the same tumor should help to define new therapeutic targets and should allow a combination of targeted and immunomodulatory therapies. To this end, our project is to conduct an exhaustive integrated exploratory analysis at genomic, transcriptomic and immunological levels of 3 tumor types (in colon, kidney and liver cancer).
Read the detailed description
The design consists in recruiting 50 patients per tumor location (colon, kidney, liver). For colorectal and kidney cancers, a prospective enrollment will be done for patients who have consented to the study. A retrospective enrollment will be done for patients with liver cancer only and who have consented to a national biological resource center form with genetic study approval.
The tumor samples will be taken during surgery. Blood and tumors samples will be taken as part of the treatment.
In case of a accidental germline discovery a management by a genetic consulting will be proposed.
- Keywords
- exhaustive genetic and immunological analyses, targeted therapies, colon cancer, kidney cancer, liver cancer, immunological tumor microenvironment, tumor microenvironment heterogeneity
- Medical subject headings
- Carcinoma, Hepatocellular, Carcinoma, Renal Cell, Colonic Neoplasms, Kidney Neoplasms, Liver 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 |
|---|---|---|
| Colorectal cancer | Patient with stage III colon carcinoma | |
| Kidney cancer | Patient with clear cell kidney carcinoma more than 4 cm surgically removed | |
| Liver cancer | Patient with advanced hepatocellular carcinoma : biopsy or resected BCLC (Barcelona Clinic Liver Cancer) stage B or C for diagnostic and/or therapeutic purposes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sequencing of the exome and tumor RNA
Molecular classification of tumors
Measured: Day of surgery
Secondary outcomes (16)
HLA (human leukocyte antigen) typing
Prediction of neoantigens implicated in the intratumoral immune response
Measured: Day of surgery
Immunophenotyping of intratumoral lymphocytes
Immunologic characteristic of tumors
Measured: Day of surgery
Densities of lymphocytes T CD8 (cluster of differentiation 8)
Immunologic characteristic of tumors
Measured: Day of surgery
Densities of macrophages M2 (CD68, CD163)
Immunologic characteristic of tumors
Measured: Day of surgery
Densities of fibroblasts (SMA)
Immunologic characteristic of tumors
Measured: Day of surgery
Quantification of lymphoid structures in immune infiltrate : DC-Lamp (Dendritic cell-lysosomal associated membrane protein)/CD3
Immunologic characteristic of tumors
Measured: Day of surgery
Quantification of lymphoid structures in immune infiltrate : CD20/CD3
Immunologic characteristic of tumors
Measured: Day of surgery
Expression profile of immune and stromal metagenes
Immunologic characteristic of tumors
Measured: Day of surgery
Quantification of lymphocytes T CD4 (activated/inhibited)
Immunologic characteristic of circulating cells
Measured: Inclusion and 4 weeks after surgery
Quantification of lymphocytes T CD8 (activated/inhibited)
Immunologic characteristic of circulating cells
Measured: Inclusion and 4 weeks after surgery
Treg profile
Immunologic characteristic of circulating cells
Measured: Inclusion and 4 weeks after surgery
MHC (major histocompatibility complex) peptide binding : Elispot
Immunologic characteristic of circulating cells
Measured: Inclusion and 4 weeks after surgery
Cytokine assay : Luminex
Immunologic characteristic of circulating cells
Measured: Inclusion and 4 weeks after surgery
Angiogenesis markers assay
Immunologic characteristic of circulating cells
Measured: Inclusion and 4 weeks after surgery
Complement components assay
Immunologic characteristic of circulating cells
Measured: Inclusion and 4 weeks after surgery
Transcriptomic profile of urinary RNAs
Expression profile of immune gene in urine
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study startMay 2017 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenocarcinomaStudies 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
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Georges Pompidou Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Responsible party
- Principal investigator, Pierre Laurent-Puig, European Georges Pompidou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149523
- Sponsor's protocol ID
- CARPEM_ExhauCRF
- Acronym
- ExhauCRF
- Status last verified
- May 2017
- First submitted
- 9 May 2017
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD (individual participant data) will not be shared. To protect confidentiality and integrity of patient information, only investigators of the study will have a regulated access to data with authorizations.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaustive Genetic and Immunological Characterization of Colon, Kidney and Liver Tumors to Define Potential Targets of Targeted and/or Immunomodulatory Therapies
- ClinicalTrials.gov ID
- NCT03149523
- Acronym / sponsor ID
- ExhauCRF / CARPEM_ExhauCRF
- Keywords
- exhaustive genetic and immunological analyses, targeted therapies, colon cancer, kidney cancer, liver cancer, immunological tumor microenvironment, tumor microenvironment heterogeneity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- European Georges Pompidou HospitalUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Study start
- May 2017 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 11 May 2017 (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.
Over the last 10 years, technological advances in molecular biology enabled a more accurate genomic characterization of tumors. For each tumor location, this led to the identification of subgroups with similar molecular characteristics. This identification allowed the development of targeted therapies and thus to improve the patient prognosis. This molecular characterization has also revealed the tumor heterogeneity. It may be the cause of treatment resistance and therefore of relapses. Additionally, tumor cells are in constant dialogue with their microenvironment composed of different immune or non immune cells. This microenvironment is now targeted in cancer treatment.
To date, there are few studies that combine a deep genomic characterization of both tumor and tumor microenvironment of the patient. Combining the two types of studies on the same tumor should help to define new therapeutic targets and should allow a combination of targeted and immunomodulatory therapies. To this end, our project is to conduct an exhaustive integrated exploratory analysis at genomic, transcriptomic and immunological levels of 3 tumor types (in colon, kidney and liver cancer).
Detailed description
The design consists in recruiting 50 patients per tumor location (colon, kidney, liver). For colorectal and kidney cancers, a prospective enrollment will be done for patients who have consented to the study. A retrospective enrollment will be done for patients with liver cancer only and who have consented to a national biological resource center form with genetic study approval.
The tumor samples will be taken during surgery. Blood and tumors samples will be taken as part of the treatment.
In case of a accidental germline discovery a management by a genetic consulting will be proposed.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Colorectal cancer | – | –Patient with stage III colon carcinoma |
| Kidney cancer | – | –Patient with clear cell kidney carcinoma more than 4 cm surgically removed |
| Liver cancer | – | –Patient with advanced hepatocellular carcinoma : biopsy or resected BCLC (Barcelona Clinic Liver Cancer) stage B or C for diagnostic and/or therapeutic purposes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colorectal, kidney or liver cancers.
Key inclusion criteria (4 listed)
- for colorectal cancer group : patient with stage III colon carcinoma
- for kidney cancer group : patient with primary clear cell carcinoma more than 4 cm
- for liver cancer group : patient with advanced hepatocellular carcinoma : biopsy or resected BCLC (Barcelona Clinic Liver Cancer) stage B or C
- patients who have consented to the study
Key exclusion criteria (1 listed)
- Patients receiving neoadjuvant therapy are not eligible
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
Sequencing of the exome and tumor RNA
Time frame: Day of surgery
Molecular classification of tumors
16 secondary outcomes
HLA (human leukocyte antigen) typing
Time frame: Day of surgery
Immunophenotyping of intratumoral lymphocytes
Time frame: Day of surgery
Densities of lymphocytes T CD8 (cluster of differentiation 8)
Time frame: Day of surgery
Densities of macrophages M2 (CD68, CD163)
Time frame: Day of surgery
Densities of fibroblasts (SMA)
Time frame: Day of surgery
Quantification of lymphoid structures in immune infiltrate : DC-Lamp (Dendritic cell-lysosomal associated membrane protein)/CD3
Time frame: Day of surgery
Quantification of lymphoid structures in immune infiltrate : CD20/CD3
Time frame: Day of surgery
Expression profile of immune and stromal metagenes
Time frame: Day of surgery
Quantification of lymphocytes T CD4 (activated/inhibited)
Time frame: Inclusion and 4 weeks after surgery
Quantification of lymphocytes T CD8 (activated/inhibited)
Time frame: Inclusion and 4 weeks after surgery
Treg profile
Time frame: Inclusion and 4 weeks after surgery
MHC (major histocompatibility complex) peptide binding : Elispot
Time frame: Inclusion and 4 weeks after surgery
Cytokine assay : Luminex
Time frame: Inclusion and 4 weeks after surgery
Angiogenesis markers assay
Time frame: Inclusion and 4 weeks after surgery
Complement components assay
Time frame: Inclusion and 4 weeks after surgery
Transcriptomic profile of urinary RNAs
Time frame: Inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Individual participant dataSharing planned: No. The IPD (individual participant data) will not be shared. To protect confidentiality and integrity of patient information, only investigators of the study will have a regulated access to data with authorizations.
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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.
Eric Tartour, MD, PhD contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Adenocarcinoma and Hepatic Carcinoma, run by European Georges Pompidou Hospital at 3 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 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 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre Laurent-Puig, MD, PhD (00331 42 86 20 81, pierre.laurent-puig@parisdescartes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sequencing of the exome and tumor RNA (time frame: Day of surgery). 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 17 May 2017.