NCT05793463

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 15, 2018

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

6.1 years

First QC Date

March 20, 2023

Last Update Submit

March 20, 2023

Conditions

Acute Lymphoblastic Leukemia

Keywords

Acute Lymphoblastic LeukemiaFertility preservationAnti-Mullerian hormone

Outcome Measures

Primary Outcomes (2)

  • Evaluation of blood AMH levels before ALL treatment

    AMH levels will be evaluated in peripheral blood

    Within one months from ALL diagnosis

  • Evaluation of blood AMH levels after ALL treatment

    AMH levels will be evaluated in peripheral blood

    24 months after ALL diagnosis

Eligibility Criteria

Age1 Month - 18 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Female less than 18 years of age with ALL

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Burlo Garofolo

Trieste, 34137, Italy

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Nagua Giurici, MD

    IRCCS materno infantile Burlo Garofolo

    STUDY DIRECTOR

Central Study Contacts

Nagua Giurici, MD

CONTACT

+390403785342nagua.giurici@burlo.trieste.it

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2023

First Posted

March 31, 2023

Study Start

February 15, 2018

Primary Completion

March 15, 2024

Study Completion

March 15, 2024

Last Updated

March 31, 2023

Record last verified: 2023-03

Locations

IT(1)