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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
  Purpose

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.


Condition
Breast Cancer
Fertility

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility

Resource links provided by NLM:


Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 200
Study Start Date: October 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adjuvant treatment
Neo adjuvant treatment

  Eligibility

Ages Eligible for Study:   18 Years to 37 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

young female, treated for non metastatic breast cancer

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01614704

Contacts
Contact: Yvette VENDEL +33 (0) 3.20.29.59.18 y-vendel@o-lambret.fr

Locations
France
Oscar Lambret Center Recruiting
Lille, Nord Pas de Calais, France, 59020
Contact: Yvette VENDEL    +33 (0) 3.20.29.59.18    y-vendel@o-lambret.fr   
Principal Investigator: Audrey MAILLIEZ, MD         
Sub-Investigator: Jacques BONNETERRE, MDPhD         
Sub-Investigator: Laurence VANLEMMENS, MD         
Sub-Investigator: Véronique SERVENT, MD         
Sub-Investigator: Anne LESOIN, MD         
Sub-Investigator: Géraldine LAURIDANT, MD         
Sub-Investigator: Philippe VENNIN, MD         
Marie Curie Center Recruiting
Arras, Pas de Calais, France, 62000
Contact: Jean-Briac PREVOST, MD       drprevost@radiopole-artois.com   
Principal Investigator: Jean-Briac PREVOST, MD         
Sub-Investigator: Hassan RHLIOUCH, MD         
Sub-Investigator: Anne-Sophie LEBLANC, MD         
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Study Chair: Audrey MAILLIEZ, MD Oscar Lambret Center
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01614704     History of Changes
Other Study ID Numbers: Cancer et fertilité - 1104
Study First Received: May 18, 2012
Last Updated: July 4, 2012
Health Authority: France: French Data Protection Authority

Keywords provided by Centre Oscar Lambret:
Breast cancer
Fertility

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014