Generation of Lung Tumor Organoids From Patients Undergoing Diagnostic Bronchoscopy

NCT ID: NCT06239584

Last Updated: 2024-02-02

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

2022-10-19

Study Completion Date

2024-02-02

Brief Summary

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Interventional (low intervention level), non-pharmacological, prospective, feasibility pilot study of the preparation of organoids starting from lung tumor tissue collected during biopsies performed via diagnostic bronchoscopy according to standard clinical practice.

Detailed Description

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Interventional, non-pharmacological, prospective, feasibility pilot study of the preparation of organoids starting from lung tumor tissue collected during biopsies performed via diagnostic bronchoscopy according to standard clinical practice. This protocol is classified as "interventional" (low intervention level) since that, if possible, an additional quantity of lung tumor tissue will be collected compared to that normally obtained as standard clinical practice, during bronchoscopy, al in order to increase the probability of successful generation of organoids. Involves the prospective recruitment of patients undergoing diagnostic bronchoscopies for suspected lung cancer.

Conditions

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Generation of Lung Cancer Organoids

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients undergoing diagnostic bronchoscopies for suspected lung cancer

Preparation of organoids starting from lung tumor tissue collected during biopsies performed via diagnostic bronchoscopy according to standard clinical practice

Group Type OTHER

Biopsies performed via bronchoscopy

Intervention Type PROCEDURE

An additional amount of lung tumor tissue will be collected compared to that normally obtained as standard clinical practice, during bronchoscopy, al in order to increase the probability of successful generation of organoids

Interventions

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Biopsies performed via bronchoscopy

An additional amount of lung tumor tissue will be collected compared to that normally obtained as standard clinical practice, during bronchoscopy, al in order to increase the probability of successful generation of organoids

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients with suspected diagnosis of centrally located and accessible lung cancer endoscopically;
* patients for whom it is indicated to undergo in-depth diagnostic testing through bronchoscopy for the purpose of determining the histotype of the lung neoplasm, according to clinical practice standard;
* aged over 18;
* patients who express informed consent to the study.

Exclusion Criteria

* medical contraindication to taking biopsy samples;
* medical contraindication to carrying out endoscopic investigations;
* patients with suspected lung cancer not accessible endoscopically;
* patients with lung neoformation already subjected to diagnostic sampling;
* contraindications to taking an additional quantity of tissue.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role collaborator

Regina Elena Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giovanni Blandino, Doctor

Role: PRINCIPAL_INVESTIGATOR

IRCCS "Regina Elena" National Cancer Institute

Locations

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"Regina Elena" National Cancer Institute

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giovanni Blandino, Doctor

Role: CONTACT

06-5266.2911 ext. +39

Federico cappuzzo, Doctor

Role: CONTACT

06.5266.5698 ext. +39

Facility Contacts

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Giovanni Blandino, Doctor

Role: primary

06-5266.2911 ext. +39

Other Identifiers

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RS1766/22

Identifier Type: -

Identifier Source: org_study_id

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