Exhaustive Genetic and Immunological Characterization of Colon, Kidney and Liver Tumors (ExhauCRF)

May 16, 2017 updated by: Pierre Laurent-Puig, European Georges Pompidou Hospital

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).

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bondy, France, 93140
        • AP-HP Jean Verdier Hospital
        • Contact:
        • Principal Investigator:
          • Jessica Zucman-Rossi, MD, PhD
      • Paris, France, 75014
      • Paris, France, 75015
        • AP-HP European Georges Pompidou Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pierre Laurent-Puig, MD, PhD
        • Sub-Investigator:
          • Stéphane Oudard, MD, PhD
        • Sub-Investigator:
          • Julien Taïeb, MD, PhD
        • Sub-Investigator:
          • Eric Tartour, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with colorectal, kidney or liver cancers.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients receiving neoadjuvant therapy are not eligible

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sequencing of the exome and tumor RNA
Time Frame: Day of surgery
Molecular classification of tumors
Day of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HLA (human leukocyte antigen) typing
Time Frame: Day of surgery
Prediction of neoantigens implicated in the intratumoral immune response
Day of surgery
Immunophenotyping of intratumoral lymphocytes
Time Frame: Day of surgery
Immunologic characteristic of tumors
Day of surgery
Densities of lymphocytes T CD8 (cluster of differentiation 8)
Time Frame: Day of surgery
Immunologic characteristic of tumors
Day of surgery
Densities of macrophages M2 (CD68, CD163)
Time Frame: Day of surgery
Immunologic characteristic of tumors
Day of surgery
Densities of fibroblasts (SMA)
Time Frame: Day of surgery
Immunologic characteristic of tumors
Day of surgery
Quantification of lymphoid structures in immune infiltrate : DC-Lamp (Dendritic cell-lysosomal associated membrane protein)/CD3
Time Frame: Day of surgery
Immunologic characteristic of tumors
Day of surgery
Quantification of lymphoid structures in immune infiltrate : CD20/CD3
Time Frame: Day of surgery
Immunologic characteristic of tumors
Day of surgery
Expression profile of immune and stromal metagenes
Time Frame: Day of surgery
Immunologic characteristic of tumors
Day of surgery
Quantification of lymphocytes T CD4 (activated/inhibited)
Time Frame: Inclusion and 4 weeks after surgery
Immunologic characteristic of circulating cells
Inclusion and 4 weeks after surgery
Quantification of lymphocytes T CD8 (activated/inhibited)
Time Frame: Inclusion and 4 weeks after surgery
Immunologic characteristic of circulating cells
Inclusion and 4 weeks after surgery
Treg profile
Time Frame: Inclusion and 4 weeks after surgery
Immunologic characteristic of circulating cells
Inclusion and 4 weeks after surgery
MHC (major histocompatibility complex) peptide binding : Elispot
Time Frame: Inclusion and 4 weeks after surgery
Immunologic characteristic of circulating cells
Inclusion and 4 weeks after surgery
Cytokine assay : Luminex
Time Frame: Inclusion and 4 weeks after surgery
Immunologic characteristic of circulating cells
Inclusion and 4 weeks after surgery
Angiogenesis markers assay
Time Frame: Inclusion and 4 weeks after surgery
Immunologic characteristic of circulating cells
Inclusion and 4 weeks after surgery
Complement components assay
Time Frame: Inclusion and 4 weeks after surgery
Immunologic characteristic of circulating cells
Inclusion and 4 weeks after surgery
Transcriptomic profile of urinary RNAs
Time Frame: Inclusion
Expression profile of immune gene in urine
Inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Georges Pompidou Hospital

Collaborators

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2017

Primary Completion (ANTICIPATED)

April 1, 2019

Study Completion (ANTICIPATED)

April 1, 2019

Study Registration Dates

First Submitted

May 9, 2017

First Submitted That Met QC Criteria

May 9, 2017

First Posted (ACTUAL)

May 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2017

Last Update Submitted That Met QC Criteria

May 16, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARPEM_ExhauCRF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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