NCT04679285

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

April 26, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2022

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

1.4 years

First QC Date

December 16, 2020

Last Update Submit

December 17, 2025

Conditions

Acute Myeloid Leukemia

Keywords

Acute myeloid leukemiaFertility preservationOvarian cryopreservationMinimal residual disease

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients without detectable MRD in ovarian tissue

    Up to 6 months

Secondary Outcomes (1)

  • Percentage of patients with MRD detected in ovarian tissue and bone marrow.

    Up to 1 month

Eligibility Criteria

Age2 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 2 to 40 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.

You may qualify if:

  • 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.

You may not qualify if:

  • Other diagnostic
  • No marker available at AML diagnosis
  • No bone marrow/ovarian fragment available at the time of complete remission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU lille

Lille, 59037, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bone marrow, blood, ovarian fragments

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteNeoplasm, Residual

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Laurène Fenwarth, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2020

First Posted

December 22, 2020

Study Start

April 26, 2021

Primary Completion

September 4, 2022

Study Completion

September 4, 2022

Last Updated

December 23, 2025

Record last verified: 2025-12

Locations

FR(1)