Minimal Residual Disease Evaluation on Cryopreserved Ovarian Fragments in Younger Patients Treated for Acute Myeloid Leukemia (FERTILAM)

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ClinicalTrials.gov Identifier: NCT04679285

Recruitment Status : Recruiting

First Posted : December 22, 2020

Last Update Posted : April 29, 2021

See Contacts and Locations

Sponsor:

Collaborators:

Canceropôle Nord Ouest

Saint-Louis Hospital, Paris, France

Information provided by (Responsible Party):

University Hospital, Lille

Study Description

Brief 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.

Condition or disease
Acute Myeloid Leukemia

Study Design

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Study Type :	Observational
Estimated Enrollment :	8 participants
Observational Model:	Cohort
Time Perspective:	Cross-Sectional
Official Title:	Pilot Study to Assess Minimal Residual Disease on Cryopreserved Ovarian Fragments in Younger Patients Treated for Acute Myeloid Leukemia
Actual Study Start Date :	April 26, 2021
Estimated Primary Completion Date :	November 2021
Estimated Study Completion Date :	December 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Familial acute myeloid leukemia with mutated CEBPA Cytogenetically normal acute myeloid leukemia Core binding factor acute myeloid leukemia

MedlinePlus related topics: Acute Myeloid Leukemia Leukemia

Genetic and Rare Diseases Information Center resources: Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

Percentage of patients without detectable MRD in ovarian tissue [ Time Frame: Up to 6 months ]

Secondary Outcome Measures :

Percentage of patients with MRD detected in ovarian tissue and bone marrow. [ Time Frame: Up to 1 month ]

Biospecimen Retention: Samples With DNA

Bone marrow, blood, ovarian fragments

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	2 Years to 25 Years (Child, Adult)
Sexes Eligible for Study:	Female
Gender Based Eligibility:	Yes
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients aged 2 to 25 year-old, who present at least one molecular marker at acute myeloid leukemia diagnosis and who undergo ovarian cryopreservation for fertility preservation at the time of complete remission, before hematopoietic stem cell transplantation.

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04679285

Contacts

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Contact: Laurène Fenwarth, MD	0320445962 ext +33	laurene.fenwarth@chru-lille.fr

Locations

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France
CHU lille	Recruiting
Lille, France, 59037
Contact 0320445962

Sponsors and Collaborators

University Hospital, Lille

Canceropôle Nord Ouest

Saint-Louis Hospital, Paris, France

Investigators

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Principal Investigator:	Laurène Fenwarth, MD	University Hospital, Lille

More Information

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Responsible Party:	University Hospital, Lille
ClinicalTrials.gov Identifier:	NCT04679285
Other Study ID Numbers:	2020_12 2020-A01513-36 ( Other Identifier: ID-RCB number,ANSM )
First Posted:	December 22, 2020 Key Record Dates
Last Update Posted:	April 29, 2021
Last Verified:	April 2021

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by University Hospital, Lille:


Acute myeloid leukemia Fertility preservation Ovarian cryopreservation Minimal residual disease

Additional relevant MeSH terms:

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Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasm, Residual	Neoplasms by Histologic Type Neoplasms Neoplastic Processes Pathologic Processes

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