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Anti-mullerian Hormone in Acute Lymphoblastic Leukemia

NCT ID: NCT05793463

Last Updated: 2023-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-15

Study Completion Date

2024-03-15

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Lymphoblastic Leukemia

Keywords

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Acute Lymphoblastic Leukemia Fertility preservation Anti-Mullerian hormone

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Burlo Garofolo

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nagua Giurici, MD

Role: STUDY_DIRECTOR

IRCCS materno infantile Burlo Garofolo

Locations

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IRCCS Burlo Garofolo

Trieste, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Nagua Giurici, MD

Role: CONTACT

Phone: +390403785342

Email: [email protected]

Facility Contacts

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Nagua Giurici, MD

Role: primary

Other Identifiers

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RC 03/17

Identifier Type: -

Identifier Source: org_study_id