Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility

This study is currently recruiting participants.

Verified July 2012 by Centre Oscar Lambret

Sponsor:

Information provided by (Responsible Party):

Centre Oscar Lambret

ClinicalTrials.gov Identifier:

NCT01614704

First received: May 18, 2012

Last updated: July 4, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 18, 2012

Last Updated Date

July 4, 2012

Start Date ^ICMJE

October 2011

Estimated Primary Completion Date

October 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

change from baseline of Anti Mullerian Hormone (AMH) rate to different time points until 24 months [ Time Frame: baseline, Day 1 of Cycle 2, Day 1 of Cycle 4, Day 1 of Cycle 6, 3 months, 6 months, 9 months, 12 months, 24 months ] [ Designated as safety issue: No ]
variation of percentages of AMH rate compared to baseline - Observe sequential chemotherapy on ovarian follicular content
change from baseline of account of antral follicles (CFA) rate to different time points until 24 months [ Time Frame: baseline, Day 1 of Cycle 2, Day 1 of Cycle 4, Day 1 of Cycle 6, 3 months, 6 months, 9 months, 12 months, 24 months ] [ Designated as safety issue: No ]
variation of percentages of CFA rate compared to baseline - Observe sequential chemotherapy on ovarian follicular content

Original Primary Outcome Measures ^ICMJE

change from baseline of Anti Mullerian Hormone (AMH) rate and account of antral follicles (CFA) rate to differents time points until 24 months [ Time Frame: baseline, Day 1 of Cycle 2, Day 1 of Cycle 4, Day 1 of Cycle 6, 3 months, 6 months, 9 months, 12 months, 24 months ] [ Designated as safety issue: No ]

variation of percentages of AMH rate and CFA rate compared to baseline - Observe sequential chemotherapy on ovarian follicular content

Change History

Complete list of historical versions of study NCT01614704 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

amenorrhea chemotherapeutically induced (weeks) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
observe chemotherapy induced amenorrhea frequency and duration of amenorrhea
correlation between amenorrhea duration and oncologic outcome (overall and free disease survival) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
collection of amenorrhea duration (weeks)
correlation between ovarian stimulation safety and oncologic outcome (overall and free disease survival) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
toxicity assessment

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility

Official Title ^ICMJE

Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility

Brief Summary

Per year, 52 000 women have breast cancer.7% are less than 40, and 2% are between 25 and 35. Most of them will be treated with chemotherapy.

One of the side effects is impact on the fertility. On 06/08/04 law basis, each patient is allowed to preserve gametes or germinal tissues when medical care potentially affect fertility.

Functional evaluation of ovarian reserve could help comprehend new chemotherapy protocols, provide fertility information, and help individualize fertility preservation supports.

Principal objective is to ensure the absence of ovarian stimulation's side effects and assess chemotherapy effects on child carrying potential.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

young female, treated for non metastatic breast cancer

Condition ^ICMJE

Breast Cancer
Fertility

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Adjuvant treatment
Neo adjuvant treatment

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

October 2015

Estimated Primary Completion Date

October 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

18 ≤ age < 38
breast cancer histologically proved
under the control of an adjuvant chemotherapy or neo adjuvant chemotherapy
verbal agreement given

Exclusion Criteria:

age ≥ 38
metastatic breast cancer
non able to follow the design of the study (geographic, social or psychological reasons)

Gender

Female

Ages

18 Years to 37 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Yvette VENDEL

+33 (0) 3.20.29.59.18

y-vendel@o-lambret.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01614704

Other Study ID Numbers ^ICMJE

Cancer et fertilité - 1104

Has Data Monitoring Committee

Responsible Party

Centre Oscar Lambret

Study Sponsor ^ICMJE

Centre Oscar Lambret

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Audrey MAILLIEZ, MD

Oscar Lambret Center

Information Provided By

Centre Oscar Lambret

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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