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Evaluation of Vascular Toxicity of Immune Checkpoint Inhibitors in Patients Head and Neck or Lung Cancer

NCT ID: NCT05655663

Last Updated: 2022-12-19

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

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-20

Study Completion Date

2025-12-20

Brief Summary

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Since the introduction of immune checkpoint ihibitors (ICIs) in cancer treatment, numerous studies have investigated different patient profiles to identify those who benefit from this class of drugs. Currently, hundreds of studies are being conducted with the aim of increasing the benefit of these therapies by combining ICIs with other treatments: immunomodulators, cytotoxics, targeted therapies, including cancer vaccines, which are peptides or RNA injected to trigger or increase a specific immune response against the tumor. Other approaches exist, such as oncology-specific "basket" studies, to focus on a genetic mutation independently of tumor location and determine whether a drug could treat the same genetic mutation found in several different locations. To date, ICIs are part of standard management in the US for patients with several diseases: advanced melanoma, NSCLC, Merkel cell carcinoma, head and neck squamous cell carcinoma, urothelial and renal cell carcinoma, cancers characterized by microsatellite instability, refractory Hodgkin's lymphoma, hepatocellular carcinoma, gastric cancer. In addition, trials are underway to investigate the benefit of ICIs in other locations.

Thus, taking into account the growing importance of ICIs in the oncological therapeutic strategy and the large number of patients treated, a better understanding of the vascular impact of these drugs is necessary.

Detailed Description

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Conditions

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Head and Neck Cancer Lung Cancer

Keywords

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immune checkpoint inhibitor head and neck cancer lung cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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ICI

Patients under ICI treatment for their cancer will have vascular investigation and biological assessment

Group Type EXPERIMENTAL

Vascular investigation

Intervention Type OTHER

Measure of of carotid stiffness

Interventions

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Vascular investigation

Measure of of carotid stiffness

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent.
* Patient over 18 years of age
* Patient with lung or head and neck cancer who should be treated with ICI as a single agent according to the market indications, decision taken during a multidisciplinary consultation meeting
* WHO 0 or 1
* Patient affiliated to or benefiting from a social protection scheme.

Exclusion Criteria

* Indication for combined anti-PD-1 and chemotherapy (for patients with lung cancer)
* History of radiotherapy treatment
* History of chemotherapy or targeted therapy within the last 3 weeks
* Bilateral vascular carotid murmur
* Absence of sinus rhythm
* Presence of a pacemaker with permanent electrical stimulation
* Absence of peripheral carotid and/or femoral pulses on both sides
* Contraindication to the prescription of an ICI
* Patient deprived of liberty by an administrative or judicial decision or patient placed under court protection, guardianship or curatorship
* Pregnant or breastfeeding woman
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Henri Becquerel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nathalie Olympios, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Henri Becquerel

Locations

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Centre Henri Becquerel

Rouen, , France

Site Status RECRUITING

CHU Rouen

Rouen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Doriane Richard, PhD

Role: CONTACT

Phone: +33232082985

Email: [email protected]

Facility Contacts

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Nathalie Olympios, MD

Role: primary

Florian Guisier, MD, PhD

Role: primary

Other Identifiers

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CHB19.02

Identifier Type: -

Identifier Source: org_study_id