NCT04767607

Brief Summary

The purpose of this study is to predict the ovarian reserve, especially premature ovarian insufficient (POI), in young breast cancer patients during chemotherapy treatment using ultrasensitive anti-Müllerian hormone (AMH) detection method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

2.1 years

First QC Date

January 26, 2021

Last Update Submit

March 5, 2024

Conditions

Breast Cancer

Keywords

Breast CancerChemotherapyovarian reserve

Outcome Measures

Primary Outcomes (1)

  • To evaluate the trend of anti-Müllerian hormone (AMH) level at chemotherapy process and post-chemotherapy in breast cancer patients.

    Serum anti-Müllerian hormone (AMH) concentration can be measured on any day during the menstrual cycle. Serum AMH will be measured at each chemotherapy administration and 1 year post-chemotherapy.

    1 year.

Secondary Outcomes (1)

  • To evaluate the trend of Follicle-Stimulating Hormone (FSH) level at chemotherapy process and post-chemotherapy in breast cancer patients.

    1 year.

Other Outcomes (1)

  • Number of participants with chemotherapy-induced amenorrhoea/oligomenorrhea and recovery rate of menses during chemotherapy process and 1 year post-chemotherapy treatment.

    1 year.

Study Arms (2)

Breast cancer plus chemotherapy

Patients of the group will receive chemotherapy treatment.

Breast cancer without chemotherapy

Patients of the group will not receive chemotherapy treatment.

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

200 premenopausal breast cancer female patients of age 18-50 treated in the International Peace Maternity and Child Health Hospital

You may qualify if:

  • Female 18-50 years.
  • Suffering from breast cancer.
  • Treated with adjuvant or neoadjuvant chemotherapy.
  • Having regular menstrual cycle before chemotherapy.

You may not qualify if:

  • Bilateral oophorectomy or ovarian irradiation before enrollment.
  • Prior chemotherapy.
  • Oral contraceptives before enrollment.
  • Pregnancy or lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The International Peace Maternity and Child Health Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (3)

  • Dezellus A, Barriere P, Campone M, Lemanski C, Vanlemmens L, Mignot L, Delozier T, Levy C, Bendavid C, Debled M, Bachelot T, Jouannaud C, Loustalot C, Mouret-Reynier MA, Gallais-Umbert A, Masson D, Freour T. Prospective evaluation of serum anti-Mullerian hormone dynamics in 250 women of reproductive age treated with chemotherapy for breast cancer. Eur J Cancer. 2017 Jul;79:72-80. doi: 10.1016/j.ejca.2017.03.035. Epub 2017 Apr 29.

    PMID: 28463758BACKGROUND

  • Freour T, Barriere P, Masson D. Anti-mullerian hormone levels and evolution in women of reproductive age with breast cancer treated with chemotherapy. Eur J Cancer. 2017 Mar;74:1-8. doi: 10.1016/j.ejca.2016.12.008. Epub 2017 Jan 28.

    PMID: 28135602BACKGROUND

  • Lie Fong S, Lugtenburg PJ, Schipper I, Themmen AP, de Jong FH, Sonneveld P, Laven JS. Anti-mullerian hormone as a marker of ovarian function in women after chemotherapy and radiotherapy for haematological malignancies. Hum Reprod. 2008 Mar;23(3):674-8. doi: 10.1093/humrep/dem392. Epub 2008 Jan 23.

    PMID: 18216040BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serm

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Dongmei Lai, M.D.

    The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 26, 2021

First Posted

February 23, 2021

Study Start

June 1, 2020

Primary Completion

July 1, 2022

Study Completion

July 1, 2023

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

The public can require the data and protocol from clinicaltrials.gov posted by investigator.

Shared Documents
STUDY PROTOCOL
Time Frame
2 years
Access Criteria
Public
More information

Locations

CN(1)