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:
Centre Oscar Lambret
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
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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 Infertility Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 16, 2013