Exhaustive Genetic and Immunological Characterization of Colon, Kidney and Liver Tumors
ExhauCRF
1 other identifier
observational
150
1 country
3
Brief 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. 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2017
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 9, 2017
CompletedFirst Posted
Study publicly available on registry
May 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedMay 17, 2017
May 1, 2017
1.9 years
May 9, 2017
May 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sequencing of the exome and tumor RNA
Molecular classification of tumors
Day of surgery
Secondary Outcomes (16)
HLA (human leukocyte antigen) typing
Day of surgery
Immunophenotyping of intratumoral lymphocytes
Day of surgery
Densities of lymphocytes T CD8 (cluster of differentiation 8)
Day of surgery
Densities of macrophages M2 (CD68, CD163)
Day of surgery
Densities of fibroblasts (SMA)
Day of surgery
- +11 more secondary outcomes
Study Arms (3)
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
Eligibility Criteria
Patients with colorectal, kidney or liver cancers.
You may qualify if:
- 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
You may not qualify if:
- Patients receiving neoadjuvant therapy are not eligible
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
AP-HP Jean Verdier Hospital
Bondy, 93140, France
AP-HP Cochin Hospital
Paris, 75014, France
AP-HP European Georges Pompidou Hospital
Paris, 75015, France
Biospecimen
blood samples, urine collection, tumor sample and tumor microenvironment sample
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
May 9, 2017
First Posted
May 11, 2017
Study Start
May 1, 2017
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
May 17, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share
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.