Assessment of the WT1 Expression Level on Bone Marrow Samples Collected at Day +60 After Allogeneic StemNCT05755633
Role of Day +60 WT1 Assessment on Bone Marrow in Predicting Relapse and Mortality After Allogeneic Stem Cell Transplantation
An observational study of Assessment of the WT1 Expression Level on Bone Marrow Samples Collected at Day +60 After Allogeneic Stem, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The rationale of this study is to determine if an association exists between WT1 expression and relapse occurrence in patients with acute myeloid leukemia submitted to allogeneic stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Assessment of the WT1 Expression Level on Bone Marrow Samples Collected at Day +60 After Allogeneic Stem
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 22 Apr 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a retrospective study which will be held on 50 patients with acute myeloid leukemia allografted in the transplant Units of Policlinico Agostino Gemelli in Rome, between June 2018 and July 2020, for whom WT1 level was assessed on bone marrow at day 60 after transplant. The minimum follow up for surviving patients will be 60 days. Patients will be classified according to European Leukemia Net criteria
Who may be able to join
- Age ≥ 18 years Diagnosis of acute myeloid leukemia Patients received allogeneic stem cell transplantation Signed informed consent to storage and use biological samples for research scope Signed informed consent to privacy
Who cannot join
- Patients who had received a previous stem cell transplant Hematological disease other than acute myeloid leukemia Patient not studied for WT1 level at day +60 after transplant
Trial locations and contacts
1 site in 1 country.
About this study
The rationale of this study is to determine if an association exists between WT1 expression and relapse occurrence in patients with acute myeloid leukemia submitted to allogeneic stem cell transplantation. In particular, we want to studied WT1 expression level on bone marrow samples of day +60 in terms of predicting power on relapse incidence so as to determine a cut-off value for identify high risk patients.
Read the detailed description
This is a retrospective study which will be held on 50 patients with acute myeloid leukemia allografted in the transplant Units of Policlinico Agostino Gemelli in Rome, between June 2018 and July 2020, for whom WT1 level was assessed on bone marrow at day 60 after transplant. The minimum follow up for surviving patients will be 60 days. Patients will be classified according to European Leukemia Net criteria. For each patient a total of 24 ml of bone marrow was collected at day +60 post transplant, whereas the same quantity of bone marrow was collected from healthy donor during bone marrow harvest procedure.
What is being measured
The primary outcome is the main question the study is designed to answer.
we want to studied WT1 expression level on bone marrow samples of day +60 in terms of predicting power on relapse incidence so as to determine a cut-off value for identify high risk patients
Measured: day 60 after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start22 Apr 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assessment of the WT1 Expression Level on Bone Marrow Samples Collected at Day +60 After Allogeneic StemStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHIUSOLO PATRIZIA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755633
- Sponsor's protocol ID
- 4065
- Status last verified
- Feb 2023
- First submitted
- 23 Feb 2023
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Day +60 WT1 Assessment on Bone Marrow in Predicting Relapse and Mortality After Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT05755633
- Acronym / sponsor ID
- 4065
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 6 Mar 2023 (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.
The rationale of this study is to determine if an association exists between WT1 expression and relapse occurrence in patients with acute myeloid leukemia submitted to allogeneic stem cell transplantation. In particular, we want to studied WT1 expression level on bone marrow samples of day +60 in terms of predicting power on relapse incidence so as to determine a cut-off value for identify high risk patients.
Detailed description
This is a retrospective study which will be held on 50 patients with acute myeloid leukemia allografted in the transplant Units of Policlinico Agostino Gemelli in Rome, between June 2018 and July 2020, for whom WT1 level was assessed on bone marrow at day 60 after transplant. The minimum follow up for surviving patients will be 60 days. Patients will be classified according to European Leukemia Net criteria. For each patient a total of 24 ml of bone marrow was collected at day +60 post transplant, whereas the same quantity of bone marrow was collected from healthy donor during bone marrow harvest procedure.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a retrospective study which will be held on 50 patients with acute myeloid leukemia allografted in the transplant Units of Policlinico Agostino Gemelli in Rome, between June 2018 and July 2020, for whom WT1 level was assessed on bone marrow at day 60 after transplant. The minimum follow up for surviving patients will be 60 days. Patients will be classified according to European Leukemia Net criteria
Key inclusion criteria (1 listed)
- Age ≥ 18 years Diagnosis of acute myeloid leukemia Patients received allogeneic stem cell transplantation Signed informed consent to storage and use biological samples for research scope Signed informed consent to privacy
Key exclusion criteria (1 listed)
- Patients who had received a previous stem cell transplant Hematological disease other than acute myeloid leukemia Patient not studied for WT1 level at day +60 after transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
we want to studied WT1 expression level on bone marrow samples of day +60 in terms of predicting power on relapse incidence so as to determine a cut-off value for identify high risk patients
Time frame: day 60 after transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Assessment of the WT1 Expression Level on Bone Marrow Samples Collected at Day +60 After Allogeneic Stem, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
we want to studied WT1 expression level on bone marrow samples of day +60 in terms of predicting power on relapse incidence so as to determine a cut-off value for identify high risk patients (time frame: day 60 after transplant). 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 6 Mar 2023.