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A Study on the Uterus, Ovarian and Reproductive Functions According to Conditioning Regimen and Pubertal Status at the Time of Stem Cell Transplantation in a Leukemia Pediatric Population (FERTILEA)

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ClinicalTrials.gov Identifier: NCT03583294
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

The French L.E.A. (Leucémie Enfant et Adolescent) program was implemented to prospectively evaluate the long-term health status, quality of life and socio-economic status of childhood acute leukemia (CAL) survivors enrolled in French treatment programs from 1980 to present, in 15 cancer centers. Eligible patients for the study are adult women (≥18 years) from L.E.A. cohort. Project has been approved by the Scientific Advisory Board and the Steering Committee of LEA Cohort. MRI uterus anatomy, follicular ovarian reserve and reproductive function will be assess in 212 adult women who received a hematopoietic stem cell transplantation (HSCT) for CAL. The investigator's objective is to correlate uterus and ovarian function to the conditioning regimen received before HSCT (total body irradiation (TBI) or busulfan - based conditioning) and the pubertal status at the HSCT (before or after puberty).Inclusion period is planned for 2 years. Four patient groups will be compared:

  • Group 1: HSCT before nine years and after conditioning regimen with TBI (12 Gy)
  • Group 2: HSCT before nine years and after a busulfan-based conditioning regimen
  • Group 3: HSCT after nine years and after conditioning regimen with TBI (12 Gy)
  • Group 4: HSCT after nine years and after a busulfan-based conditioning regimen

Information will be collected during specific medical visit in one of the investigatory centers. Pelvic MRI and hormonal blood tests will be performed and a medical consultation with a physician specialized in reproductive medicine and oncofertility will be proposed to eligible patients. Data assessed for each women are the following:

  • Disease type, age and pubertal status at HSCT, age at evaluation, therapy lines before and after HSCT, conditioning regimen, relapse after HSCT if applicable. Cumulative doses of cyclophosphamide, melphalan, busulfan and radiation will be collected from the LEA database.
  • Gynecological characteristics: spontaneous or induced puberty, spontaneous menstrual cycles or Hormone Substitutive treatment (HRT) or amenorrhea without HRT; gestity parity (if pregnancy: spontaneous, after Assisted Reproductive Technologies?), history of ovarian cryopreservation, was information given (and at what age?) about risk of premature ovarian failure and about the gyneco-obstetrical impact of conditioning regimen for HSCT?
  • Ovarian follicular reserve: FSH, LH, estradiol, Anti-Müllerian Hormon (AMH) at the day 2-3 of the cycle or whenever if amenorrhea. Ovarian volume and antral Follicle Count will be performed with pelvic sonography.
  • Uterine anatomy by MRI, at the end of follicular phase or after estrogen therapy, in order to measure proliferative endometrium. Anatomical parameters will be compare to normal measurements of uterus: uterine volume, myometrial, endometrial and junctionnal zone thickness, cervical length, apparent diffusion coefficient values.
  • Reproductive function: spontaneous pregnancy rate or after ART (IVF, oocyte donation), term and mode of delivery, health of the child.

Condition or disease Intervention/treatment Phase
Leukemia Other: MRI pelvic Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Study on the Uterus, Ovarian and Reproductive Functions According to Conditioning Regimen and Pubertal Status at the Time of Stem Cell Transplantation in a Leukemia Pediatric Population
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arm Intervention/treatment
Experimental: irradiation regimen before 9
Female who received a hematopoietic stem cell transplantation (HSCT) for AML/CML before 9 years old after conditioning regimen with total body irradation MRI pelvic will be performed
Other: MRI pelvic
Pelvic MRI

Experimental: busulfan regimen before 9
Female who received a hematopoietic stem cell transplantation (HSCT) for AML/CML before 9 years old after a busulfan-based conditioning regimen MRI pelvic will be performed
Other: MRI pelvic
Pelvic MRI

Experimental: irradiation regimen after 9
Female who received a hematopoietic stem cell transplantation (HSCT) for AML/CML after 9 years old after conditioning regimen with total body irradation MRI pelvic will be performed
Other: MRI pelvic
Pelvic MRI

Experimental: busulfan regimen after 9
Female who received a hematopoietic stem cell transplantation (HSCT) for AML/CML after 9 years old after a busulfan-based conditioning regimen MRI pelvic will be performed
Other: MRI pelvic
Pelvic MRI




Primary Outcome Measures :
  1. Uterin Anatomy [ Time Frame: 1 day ]

    Pelvic echography: Quantitative estimation of the residual ovarian reserve with the count of antral follicles and the thickness of the endometrium and ovarian volume

    Pelvic IRM: the maximum size of functional endometrium in the proliferative phase




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female treated for acute/chronic myeloide leukemia during chidwood and survived from this desease

Exclusion Criteria:

  • Female with uneligible MRI exam conditions

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): NCT03583294


Contacts
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Contact: Blandine COURBIERE, MD/PhD +33 491383675 blandine.courbiere@ap-hm.fr

Locations
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France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: Blandine Courbiere, MD/PhD       blandine.courdbiere@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: EMILIE GARRIDO PRADALIE Assistance Publique Hôpitaux de Marseille
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03583294    
Other Study ID Numbers: 2017-32
2017-32 ( Other Identifier: AP-HM )
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Neoplasms by Histologic Type
Neoplasms