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Prospective Collection of Tumor Biopsy and Plasma Samples From Cancer Patients Treated With Molecular Targeted Therapies or Immunotherapy

NCT ID: NCT03835520

Last Updated: 2023-12-11

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-11

Study Completion Date

2028-05-01

Brief Summary

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The purpose of this study is to collect blood samples, as well as tumor tissue for genetic analysis. The collection of samples will allow the creation of a plasma bank. Targeted individuals are cancer patients of all types, treated with immunotherapy or targeted therapy.

Immunotherapy or targeted agents will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions.

With the aim to identify predictive markers of response to treatment or possible resistance mechanism, the plasma samples and the tumor samples will be used for genetic analysis, for example but not limited to, whole exome sequencing. This may lead to the discovery of some germinal mutations implicated in other diseases than cancer.

Detailed Description

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Conditions

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Cancer

Keywords

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Immunotherapy Molecular Targeted Therapies Tumor Biopsy Plasma Samples

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The trial will include patients with any type of cancer treated with one of the following regimens after signing of the patient's informed consent:

* I: Molecular targeted agent
* II: Immunotherapy
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Masking and allocation tbc

Study Groups

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MOLECULAR TARGETED THERAPIES

Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions.

Group Type EXPERIMENTAL

Molecular Target

Intervention Type DRUG

Targeted agents will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions.

IMMUNOTHERAPY

Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium.

Group Type EXPERIMENTAL

Immunotherapeutic Agent

Intervention Type DRUG

Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium.

Interventions

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Immunotherapeutic Agent

Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium.

Intervention Type DRUG

Molecular Target

Targeted agents will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with cancer treated with one of the following regimens: Molecular targeted agents or Immunotherapy
* Paraffin-embedded tumor tissue available for immunohistochemistry and/or DNA extraction.
* Patient able to give written informed consent.

Exclusion Criteria

* Patients with cancer treated with other regimen
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2018/11JUI/248

Identifier Type: REGISTRY

Identifier Source: secondary_id

B403201836842

Identifier Type: OTHER

Identifier Source: secondary_id

UCL-ONCO 2018-02

Identifier Type: -

Identifier Source: org_study_id