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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A03112-51 | Other Identifier | ANSM |
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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.
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:
and a consultation in gynecology consisting of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Process | Experimental | Consultation, Biological Test, Pelvic Ultrasound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Consultation | Procedure | Consultation in oncology: collection of oncological data and ongoing cancer treatments, clinical exam Consultation in gynecology: collection of gynecological data, contraception and reproductive medicine |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of fertility in terms of cumulative incidence of long-term pregnancy | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of fertility in terms of cumulative incidence of births | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Audrey MAILLIEZ, MD | Centre Oscar Lambret | Study Director |
| Christine DECANTER, MD | Centre Hopsitalier Regional Universitaire de Lille - Hôpital Jeanne de Flandre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Oscar Lambret | Lille | France |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| Biological Test | Biological | Blood test:
|
|
| Pelvic Ultrasound | Procedure | Antral Follicles Count |
|
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 | 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 | 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 | 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 | 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 | 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 |
| D017437 |
| Skin and Connective Tissue Diseases |