Exhaustive Genetic and Immunological Characterization of Colon, Kidney and Liver Tumors

NCT ID: NCT03149523

Last Updated: 2017-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-31

Study Completion Date

2019-04-30

Brief Summary

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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

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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.

Conditions

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Colorectal Adenocarcinoma Hepatic Carcinoma Kidney Adenocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Colorectal cancer

Patient with stage III colon carcinoma

No interventions assigned to this group

Kidney cancer

Patient with clear cell kidney carcinoma more than 4 cm surgically removed

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role collaborator

European Georges Pompidou Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pierre Laurent-Puig

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AP-HP Jean Verdier Hospital

Bondy, , France

Site Status

AP-HP Cochin Hospital

Paris, , France

Site Status

AP-HP European Georges Pompidou Hospital

Paris, , France

Site Status

Countries

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France

Central Contacts

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Pierre Laurent-Puig, MD, PhD

Role: CONTACT

00331 42 86 20 81

Eric Tartour, MD, PhD

Role: CONTACT

Facility Contacts

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Jean-Charles Nault, MD

Role: primary

Michael Peyromaure, MD, PhD

Role: primary

Jérôme Alexandre, MD, PhD

Role: backup

Pierre Laurent-Puig, MD, PhD

Role: primary

Eric Tartour, MD, PhD

Role: backup

Other Identifiers

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CARPEM_ExhauCRF

Identifier Type: -

Identifier Source: org_study_id

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