- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03795246
Follow-up of Sequential Chemotherapy and Stimulation for Fertility Preservation in Young Patients With Breast Cancer (KSF2)
February 2, 2022 updated by: Centre Oscar Lambret
Long-term Follow-up of Sequential Chemotherapy and Stimulation for Fertility Preservation in Young Patients Treated for a Breast Cancer
Interventional research with low risks and constraints, prospective and monocentric on the assessment of long-term fertility in patients who underwent an adjuvant sequential chemotherapy with or without a controled ovarian hyperstimulation.
This study follows a previous one called NCT 01614704.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The patients will have a follow-up once a year during ten years beginning at the end of their chemotherapy.
They will have a consultation in oncology consisting of:
- a clinical exam,
- a collection and follow-up of oncological data
- a collection of ongoing cancer treatments
and a consultation in gynecology consisting of:
- a pelvic ultrasound scan (for AFC: Antral Follicle Count)
- a biological test (FSH, LH, E2, AMH)
- a collection of gynecological data, contraception and reproductive medicine
Study Type
Interventional
Enrollment (Anticipated)
132
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lille, France
- Centre Oscar Lambret
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Patients included in the study CT 01614704
- Informed and written consent
- Affiliated to the National Social Security System
Exclusion Criteria:
- Impossibility to submit at the study procedures due to geographic, social or mental reasons
- Patient deprived of their liberty or under guardianship or tutorship.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study Process
Consultation, Biological Test, Pelvic Ultrasound
|
Consultation in oncology: collection of oncological data and ongoing cancer treatments, clinical exam Consultation in gynecology: collection of gynecological data, contraception and reproductive medicine
Blood test:
Antral Follicles Count
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of fertility in terms of cumulative incidence of long-term pregnancy
Time Frame: 10 years after chemotherapy
|
for patients who underwent adjuvant sequential chemotherapy of anthracycline and taxane separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation
|
10 years after chemotherapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of fertility in terms of cumulative incidence of births
Time Frame: 10 years after chemotherapy
|
separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation
|
10 years after chemotherapy
|
Assessment of fertility - number of pegnancies spontaneous versus assisted
Time Frame: 10 years after chemotherapy
|
describing the pregnancy type - number of pegnancies spontaneous versus assisted, with ot without the use of frozen gametes)
|
10 years after chemotherapy
|
Assessment of fertility - pregnancy outcome : miscarriage or single or multiple birth separately
Time Frame: 10 years after chemotherapy
|
describing the pregnancy outcome : miscarriage or single or multiple birth separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation
|
10 years after chemotherapy
|
Assessment of the number of patient willing to re-exploit their frozen gametes
Time Frame: 10 years after chemotherapy
|
for patients who have had Controlled Ovarian Hyperstimulation
|
10 years after chemotherapy
|
Assessment of the gonadotoxicity of the adjuvant sequential chemotherapy based on anthracyclines and taxanes - AMH rate
Time Frame: 10 years after chemotherapy
|
in terms of AMH rate depending on whether or not they have had Controlled Ovarian Hyperstimulation
|
10 years after chemotherapy
|
Assessment of the gonadotoxicity of the adjuvant sequential chemotherapy based on anthracyclines and taxanes - Antral Follicle Count
Time Frame: 10 years after chemotherapy
|
in terms of Antral Follicle Count depending on whether or not they have had Controlled Ovarian Hyperstimulation
|
10 years after chemotherapy
|
Study the long-term carcinologic safety of Controlled Ovarian Hyperstimulation without Letrozole or Tamoxifen co-treatment in terms of survival without relapse
Time Frame: After chemotherapy ad until disease progression or death regardless of the cause, up to 10 years after chemotherapy
|
Survival without relapse defined by the time frame between the date of surgery and the date of the first recurrence
|
After chemotherapy ad until disease progression or death regardless of the cause, up to 10 years after chemotherapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Audrey MAILLIEZ, MD, Centre Oscar Lambret
- Study Director: Christine DECANTER, MD, Centre Hopsitalier Regional Universitaire de Lille - Hôpital Jeanne de Flandre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 23, 2018
Primary Completion (Anticipated)
January 1, 2028
Study Completion (Anticipated)
January 1, 2028
Study Registration Dates
First Submitted
December 31, 2018
First Submitted That Met QC Criteria
January 4, 2019
First Posted (Actual)
January 7, 2019
Study Record Updates
Last Update Posted (Actual)
February 3, 2022
Last Update Submitted That Met QC Criteria
February 2, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KSF2-1707
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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