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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04679285
Other study ID # 2020_12
Secondary ID 2020-A01513-36
Status Recruiting
Phase
First received
Last updated
Start date April 26, 2021
Est. completion date December 2021

Study information

Verified date April 2021
Source University Hospital, Lille
Contact Laurène Fenwarth, MD
Phone 0320445962
Email laurene.fenwarth@chru-lille.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cryopreservation of ovarian cortex represents an option for fertility preservation in patients diagnosed with acute myeloid leukemia and requiring allogeneic stem cell transplantation. This pilot study aims to evaluate the minimal residual disease on ovarian fragments harvested before allogeneic stem cell transplantation at the time of complete remission.


Recruitment information / eligibility

Status Recruiting
Enrollment 8
Est. completion date December 2021
Est. primary completion date November 2021
Accepts healthy volunteers No
Gender Female
Age group 2 Years to 25 Years
Eligibility Inclusion Criteria: - Patient diagnosed with AML - At least one molecular marker identified at AML diagnosis - Patients who undergo ovarian tissue cryopreservation for fertility preservation in complete remission, before hematopoietic stem cell transplantation. Exclusion Criteria: - Other diagnostic - No marker available at AML diagnosis - No bone marrow/ovarian fragment available at the time of complete remission

Study Design


Locations

Country Name City State
France CHU lille Lille

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Lille Canceropôle Nord Ouest, Saint-Louis Hospital, Paris, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patients without detectable MRD in ovarian tissue Up to 6 months
Secondary Percentage of patients with MRD detected in ovarian tissue and bone marrow. Up to 1 month
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