Molecular Characterizazion and Biological Samples Centralisation of Patients Affected by Oncoematolofic Pathology

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-05

Study Completion Date

2028-07-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Currently, the molecular characterization of onco-hematological, onco-immunological and hematological diseases, at onset or in relapse, of patients with suspected diagnosis afferent to the CROP centers, is done through centralization of biological samples at reference laboratories outside the Tuscany Region.

In order to preserve the wealth of clinical and biological data and use it for the benefit of present and future patients treated at the CROP centers, it is useful to evaluate the feasibility of centralization and molecular typing of mutations present in tumor tissue at the IRCCS AOU Meyer Oncohematology Laboratories and subsequently the analysis of clinical data from patients with diseases not under study to lay the foundations of a translational database that can then be associated with a biobank in the future.

This will enable a targeted contribution to pediatric oncohematology research, investing in possible targeted therapies with those patient subgroups that benefit from personalized disease assessment in mind. The goal of the project is to improve the regional infrastructure dedicated to organized data collection and management of biological samples in adequate time resulting in better and more comprehensive data collection.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The ONCOCAMP Study

NCT06270602

Oncology

RECRUITING

Collecting and Storing Samples of Blood and Tumor Tissue From Patients With Osteosarcoma

NCT00899275

Osteosarcoma

COMPLETED

S9910, Collecting and Storing Blood and Bone Marrow Samples From Patients With Hematologic Cancer

NCT00919425

Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms

COMPLETED

Collection of Retrospective (Archival) Samples and Prospective Collection of Surplus Tissue and Blood Samples

NCT02239575

Cancer

WITHDRAWN

Collection of Blood, Bone Marrow, Tumor, or Tissue Samples From Patients With Cancer to Study Drug Resistance

NCT00026663

Renal Cell Carcinoma Lung Carcinoma Cervical Carcinoma

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oncologic Disease Hematologic Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with suspected diagnostic onco-hematologic/immunologic disease

All patients with suspected diagnostic onco-hematologic, onco-immunologic, and hematologic disease at onset or relapse.

Patients undergo several procedures to complete the diagnostic process and eventually the staging of the disease

Group Type OTHER

Analysis of biological samples

Intervention Type OTHER

The collected biological sample will be isolated and the specific nucleic acid (DNA/RNA/cfDNA) extracted for molecular analysis for understanding the reproducibility of the analysis and thus the feasibility of centralization:

* hot spot on DNa (ddPCR/Sanger)
* fusion genes on RNA (target resequencing)
* Known mutation analysis by liquid biopsy (cfDNA) for somatic mutations with a mutation frequency of less than 10%
* Tumor type-associated gene sequence analysis by Sanger sequencing and NGS

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Analysis of biological samples

The collected biological sample will be isolated and the specific nucleic acid (DNA/RNA/cfDNA) extracted for molecular analysis for understanding the reproducibility of the analysis and thus the feasibility of centralization:

* hot spot on DNa (ddPCR/Sanger)
* fusion genes on RNA (target resequencing)
* Known mutation analysis by liquid biopsy (cfDNA) for somatic mutations with a mutation frequency of less than 10%
* Tumor type-associated gene sequence analysis by Sanger sequencing and NGS

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnostic suspicion of oncologic, hematologic or onco-immunologic disease
* Suspected recurrence of oncological, onco-hematological, hematological or onco -immunological disease
* Availability of biological material
* Signature of informed consent
* Age between 0 and 30 years

Exclusion Criteria

* Failure to sign the consent
* Insufficiency of biological material for analysis
* Patients with HIV, HCV and HBV seropositivity (HBSAg) due to biohazard and bias related to patients' immunological status that could influence gene expression and tumor behavior.

Minimum Eligible Age

0 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No