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NCT05793463 Clinical Trial

Anti-mullerian Hormone in Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05793463
Other study ID # RC 03/17
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 15, 2018
Est. completion date March 15, 2024

Study information
Verified date March 2023
Source IRCCS Burlo Garofolo
Contact Nagua Giurici, MD
Phone +390403785342
Email nagua.giurici@burlo.trieste.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date March 15, 2024
Est. primary completion date March 15, 2024
Accepts healthy volunteers No
Gender Female
Age group 1 Month to 18 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy IRCCS Burlo Garofolo Trieste

Sponsors (1)
Lead Sponsor Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of blood AMH levels before ALL treatment AMH levels will be evaluated in peripheral blood Within one months from ALL diagnosis
Primary Evaluation of blood AMH levels after ALL treatment AMH levels will be evaluated in peripheral blood 24 months after ALL diagnosis
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