Oncologic DiseaseNCT06304194
Molecular Characterizazion and Biological Samples Centralisation of Patients Affected by Oncoematolofic Pathology
A study testing Analysis of biological samples in people with Oncologic Disease and Hematologic Diseases, run by Meyer Children's Hospital IRCCS at 3 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 30 years
- Conditions the study is for
- Oncologic Disease, Hematologic Diseases
- What is being tested?
- Analysis of biological samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 3 sitesItaly
- Study dates
- 5 Jul 2023to 5 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Recruiting
Meyer Children's Hospital IRCCS
Florence
Marinella Veltroni, marinella.veltroni@meyer.it
- Recruiting
Azienda Ospedaliero-Universitaria Pisana
Pisa
Gabriella Casazza
- Recruiting
Azienda Ospedaliero-Universitaria Senese
Siena
Salvatore Grosso
About this study
Official title: Pilot Study to Assess the Feasibility of Centralizing Biological Samples at Onset and Relapse of Patients Referred to CROP Centers for Molecular Characterization of Oncohematologic Pathology
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.
- Conditions
- Oncologic Disease, Hematologic Diseases
- Being tested
- Analysis of biological samples
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of biological samplesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected diagnostic onco-hematologic/immunologic disease | Other | 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 Receives: Other: Analysis of biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average sample delivery time and % of accepted sample
average sample delivery time and % of samples accepted within 48 ±12 hours of collection out of total samples sent
Measured: After 5 year from the beginning of the study
Appropriateness sample labelling
% samples correctly labelled according to IATA criteria out of total samples accepted within 48 hours
Measured: After 5 year from the beginning of the study
Percentage of sample suitable for RNA extraction
% samples suitable for RNA extraction out of total samples intended for RNA analysis
Measured: After 5 year from the beginning of the study
Quantity and quality of extracted material.
% of samples valid for analysis in terms of quantity of extracted material (25 ng/ul for cfDNA, 25 ng per amplicon for genomic DNA, 100 ng tot for NGS) and quality, assessed as A260/280 ratio analysis (1.8-2 per DNA).
Measured: After 5 year from the beginning of the study
Research report production time
research report production time (from 2 weeks for known mutation analysis to 6 months for NGS).
Measured: After 5 year from the beginning of the study
Secondary outcomes (2)
Genetic variants
% variants validated with NGS and Sanger or in two independent experiments out of the total number of variants identified
Measured: After 5 year from the beginning of the study
Completed patient cards
% of completed patient cards out of total patient cards of registered patients
Measured: After 5 year from the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start5 Jul 2023
- Primary completion5 Jul 2027 (estimated)
- Study completion5 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncologic DiseaseStudies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marinella Veltroni, Meyer Children's Hospital IRCCS
- Investigators
- Marinella Veltroni, Principal investigator, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304194
- Sponsor's protocol ID
- BIOMARC_ONCO
- Status last verified
- Mar 2024
- First submitted
- 23 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess the Feasibility of Centralizing Biological Samples at Onset and Relapse of Patients Referred to CROP Centers for Molecular Characterization of Oncohematologic Pathology
- ClinicalTrials.gov ID
- NCT06304194
- Acronym / sponsor ID
- BIOMARC_ONCO
- Conditions
- Oncologic Disease, Hematologic Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 5 Jul 2027 (estimated)
- Study completion
- 5 Jul 2028 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected diagnostic onco-hematologic/immunologic disease | Other | Other: Analysis of biological samplesAll 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 |
Who may qualify
- Ages
- 0 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of biological samplesThe 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 | Other | Patients with suspected diagnostic onco-hematologic/immunologic disease |
Primary outcome
Average sample delivery time and % of accepted sample
Time frame: After 5 year from the beginning of the study
average sample delivery time and % of samples accepted within 48 ±12 hours of collection out of total samples sent
Appropriateness sample labelling
Time frame: After 5 year from the beginning of the study
% samples correctly labelled according to IATA criteria out of total samples accepted within 48 hours
Percentage of sample suitable for RNA extraction
Time frame: After 5 year from the beginning of the study
% samples suitable for RNA extraction out of total samples intended for RNA analysis
Quantity and quality of extracted material.
Time frame: After 5 year from the beginning of the study
% of samples valid for analysis in terms of quantity of extracted material (25 ng/ul for cfDNA, 25 ng per amplicon for genomic DNA, 100 ng tot for NGS) and quality, assessed as A260/280 ratio analysis (1.8-2 per DNA).
Research report production time
Time frame: After 5 year from the beginning of the study
research report production time (from 2 weeks for known mutation analysis to 6 months for NGS).
2 secondary outcomes
Genetic variants
Time frame: After 5 year from the beginning of the study
Completed patient cards
Time frame: After 5 year from the beginning of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marinella Veltroni principal investigator
Meyer Children's Hospital IRCCS
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analysis of biological samples in people with Oncologic Disease and Hematologic Diseases, run by Meyer Children's Hospital IRCCS at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marinella Veltroni (0555662606, marinella.veltroni@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average sample delivery time and % of accepted sample (time frame: After 5 year from the beginning of the study). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.