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Clinical Trials/NCT05793463
NCT05793463
Recruiting
Not Applicable

Anti-mullerian Hormone in Pediatric Patients Treated for Acute Lymphoblastic Leukemia

IRCCS Burlo Garofolo1 site in 1 country10 target enrollmentFebruary 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Lymphoblastic Leukemia
Sponsor
IRCCS Burlo Garofolo
Enrollment
10
Locations
1
Primary Endpoint
Evaluation of blood AMH levels after ALL treatment
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Acute lymphoblastic leukemia (ALL) is the most common childhood malignancy, with current survival rates exceeding 90%. As cure rates improve, increasing attention is focused on survivor quality of life, including fertility. It is generally accepted that cancer treatments in childhood may interfere with gonadal function, reducing the pool of primordial follicles and consequently causing premature menopause in women. Anti-Mullerian hormone (AMH) levels is a valuable quantitative indicator of ovarian reserve, being directly related to the number of antral follicles. The evaluation of this hormone makes it possible to identify women at risk of early menopause and to propose them interventions for monitoring and preservation of oocytes, allowing girls to be able to have children once they reach adulthood. The objective of this study is to determine ovarian reserve in girls with ALL before and after treatment by means of the evaluation of the AMH assay.

Registry
clinicaltrials.gov
Start Date
February 15, 2018
End Date
March 15, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
IRCCS Burlo Garofolo
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Female less than 18 years of age
  • Diagnosis of acute lymphoblastic leukemia
  • enrollment within the first month after diagnosis

Exclusion Criteria

  • Previous treatments with cytostatics drugs
  • ALL as a second malignancy
  • Syndromic patient or primary hypogonadism

Outcomes

Primary Outcomes

Evaluation of blood AMH levels after ALL treatment

Time Frame: 24 months after ALL diagnosis

AMH levels will be evaluated in peripheral blood

Evaluation of blood AMH levels before ALL treatment

Time Frame: Within one months from ALL diagnosis

AMH levels will be evaluated in peripheral blood

Study Sites (1)

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