Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways

NCT ID: NCT04349293

Last Updated: 2020-04-16

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

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-08

Study Completion Date

2021-09-30

Brief Summary

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Multicentric interventional prospective study with collection of biological samples as part of a routine care research

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Patients with cancer

Group Type EXPERIMENTAL

Tissue sampling

Intervention Type PROCEDURE

Collection of a sample of tumor tissue and a sample of adjacent or counter lateral healthy tissue (if possible) from the surgical room

Blood sampling

Intervention Type PROCEDURE

Collection of a 30mL peripheral blood sample in heparin at several times: during surgical and medical treatment (before surgery, before the start of mAbs and after mAbs)

Interventions

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Tissue sampling

Collection of a sample of tumor tissue and a sample of adjacent or counter lateral healthy tissue (if possible) from the surgical room

Intervention Type PROCEDURE

Blood sampling

Collection of a 30mL peripheral blood sample in heparin at several times: during surgical and medical treatment (before surgery, before the start of mAbs and after mAbs)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Age greater than or equal to 18 years.
2. Male and female sex.
3. Any patient with cancer (see list in the body of the protocol) requiring treatment by surgical resection and / or who will start treatment with mAb or BiTE.
4. Patient information and signed informed consent.
5. Subjects affiliated (or beneficiary) to a social security scheme

Patients treated for immune complications by immunosuppressants may be included (corticosteroids, etc.).

Exclusion Criteria

1. History of severe systemic autoimmune disease.
2. Pregnant or breastfeeding patient
3. Impossibility or refusal to sign informed consent
4. Patient under guardianship or curatorship, or deprived of liberty by a judicial or administrative decision
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Gustave Roussy

Villejuif, Val De Marne, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Laurence ZITVOGEL, MD, PhD

Role: CONTACT

0142114211 ext. +33

Agathe DUBUISSON, PhD

Role: CONTACT

0142114211 ext. +33

Facility Contacts

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Agathe DUBUISSON, PhD

Role: primary

0142114211 ext. +33

Other Identifiers

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2015/2331

Identifier Type: OTHER

Identifier Source: secondary_id

2016-A00732-49

Identifier Type: -

Identifier Source: org_study_id

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