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FErtility, PrEgnancy, contRaceptIon After Breast Cancer in France (FEERIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884413
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : March 27, 2019
Sponsor:
Collaborator:
seintinelles network
Information provided by (Responsible Party):
Institut Curie

Brief Summary:
FErtility, PrEgnancy, contRaceptIon after breast Cancer in France

Condition or disease Intervention/treatment
Breast Cancer Female Other: questionnaires

Detailed Description:

Breast cancer is the most common cancer among women. With the increase of the survival rates, a growing attention is paid to the side effects of the treatments, particularly chemotherapy-induced infertility.

The FEERIC study will give insights into spontaneous fertility outcomes following breast cancer in comparison with a control cohort and will provide data to help patients counselling towards spontaneous fertility rates following breast cancer. It will also provide data on contraceptive prevalence and unintended pregnancy rates in French breast cancer survivors. Reasons for unmet need for family planning will be deciphered, in order to point out pitfalls (lack of patient's information or orientation/ignorance of contraception methods available/topic insufficiently or not discussed with the physician/ lack of family planning offer etc…); and target the appropriate actions to lead (oncologist and oncology nurses education/ dedicated consultations in breast cancer centers/etc…).

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Study Type : Observational
Estimated Enrollment : 1004 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: FErtility, PrEgnancy, contRaceptIon After Breast Cancer in France: the FEERIC Study
Actual Study Start Date : March 8, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Breast cancer survivors
Study of spontaneous fertility outcomes following breast cancer history
Other: questionnaires
Longitudinal observational study. Collection of health data using self-administered questionnaires online.

Control group
Study of spontaneous fertility outcomes in healthy volonteers population
Other: questionnaires
Longitudinal observational study. Collection of health data using self-administered questionnaires online.




Primary Outcome Measures :
  1. Spontaneous pregnancies between cases and controls [ Time Frame: 3 years ]
    Odds ratio between the spontaneous pregnancies between cases and controls, for women with a desire to become pregnant and trying to get pregnant.


Secondary Outcome Measures :
  1. Time to spontaneous pregnancy [ Time Frame: 3 years ]
    Time to spontaneous pregnancy after breast cancer diagnosis, for women with a desire to become pregnant and trying to get pregnant.

  2. Contraceptive prevalence [ Time Frame: 3 years ]
    Contraceptive use, defined as the percentage of women reporting use of a contraceptive method.

  3. Rate of women considered with risk of unintended pregnancy [ Time Frame: 3 years ]
    An unwanted pregnancy is defined as unwanted at the time of conception. Women are classified as at risk of unwanted pregnancy if they report having had unprotected sex without a desire to become pregnant in the previous four months.

  4. Percentage of live births obtained by medically assisted procreation procedures [ Time Frame: 3 years ]
    Percentages live births obtained by ARTs procédures, that include in vitro fertilization (IVF) and embryo transfer (ET), intracytoplasmic sperm injection (ICSI) and ovarian stimulation with exogenous gonadotropins.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women with previous diagnosis of breast cancer and time from diagnosis comprised between one and five years
Criteria

Inclusion Criteria:

  • females aged from 18 to 43 at inclusion
  • previous diagnosis of breast cancer and time from diagnosis comprised between one and five years or women free from breast cancer or other malignancy (healthy volunteers) .

Exclusion Criteria:

  • hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy
  • healthy volonteer with history of malignant disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884413


Contacts
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Contact: Laura SABLONE 06.07.44.74.36 ext 33 1 laura.sablone@seintinelles.com

Locations
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France
Seintinelles.Com Recruiting
Paris, France
Contact: Laura SABLONE    06.07.44.74.36 ext 33 1    laura.sablone@seintinelles.com   
Principal Investigator: Fabien REYAL, MD         
Principal Investigator: Charles CHAPRON, Pr         
Principal Investigator: Marc ESPIE, MD         
Principal Investigator: Isabelle RAY-COQUARD, Pr         
Principal Investigator: Audrey MAILLIEZ, MD         
Principal Investigator: Claire SENECHAL, MD         
Sponsors and Collaborators
Institut Curie
seintinelles network
Investigators
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Principal Investigator: Anne-Sophie HAMY-PETIT, MD Institut Curie
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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT03884413    
Other Study ID Numbers: IC 2016-07
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Curie:
breast cancer survivors,
spontaneous fertility rates,
pregnancy,
birth rate,
chemotherapy-induced infertility
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases