Breast Cancer FemaleARTEMISNCT03470935
Non-interventional Study Evaluating Gynecological Impact of Diagnosis and Treatment of Breast Cancer in Patients Younger
An observational study of Breast Cancer Female, run by Hôpital Privé des Côtes d'Armor (HPCA) at 1 site in France.
Trial summary
Brest cancer is the most common cancer in women in France with 52.000 new cases diagnosed in 2010 including nearly 6.000 women younger than 40. The improvement of the fertility conservation of cancer patients is one of the goals put forward by the french Cancer Plan (Objective 8.1). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Breast Cancer Female
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2017to 30 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: patients aged between 18 and 40 years at the time of diagnosis of non-metastatic breast cancer and having completed their radiotherapy and/or chemotherapy treatment(s) for at least 3 months
Who may be able to join
- Patient with non-metastatic breast cancer ;
- Age of patient between 18 and 40 years at histological diagnosis ;
- Patient treated with neoadjuvant or adjuvant chemotherapy with or without radiotherapy or endocrine therapy ;
- Patient who have completed their chemotherapy and/or radiotherapy treatment for at least 3 months at the time of questionnaire dispatch ;
- Patient informed of the study (patient must have received the informed consent document and doesn't opposed to it) and who answered to the specific questionnaire of the study ;
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-interventional Study Evaluating the Gynecological Impact of Diagnosis and Treatment of Breast Cancer in Patients Younger Than 40 Years (ARTEMIS)
Brest cancer is the most common cancer in women in France with 52.000 new cases diagnosed in 2010 including nearly 6.000 women younger than 40.
The improvement of the fertility conservation of cancer patients is one of the goals put forward by the french Cancer Plan (Objective 8.1).
Read more
The issue of fertility after a breast cancer is a frequently raised subjects by the concerned couples today. The improvement in prognosis due to therapeutic advances combined with the increasing age of the first pregnancy and in the recomposed couples bring number of young women between 35 and 40 years followed for breast cancer today to raise these questions with their oncologists.
Young women have a greater risk to develop agressive tumors requiring a mulitimodal treatment whose general and gonadic side effects can be important and permanently impact the reproductive capacity. At the time of diagnosis, almost 50% of these young patients report that they want to consider a later pregnancy but no data are available on the evolution of this wish over time although it is known that anti-cancer treatments have a serious impact on future possibilities of pregnancy(s).
The sequential chemotherapy regimen prescribed in adjuvant or neo-adjuvant situation includes intercaling agents (antracyclines) and an alkylating agent (cyclophosphamide) partially responsible for subsequent fertility disorders. In addition, a chemotherapy-induced amenorrhea (CAI) occurs in 50 to 80% of women according to the studies, the latter is sometines definitive and sequellar of treatment. However, few data describe the time of recovery of menstrual cycles in women with CAI and subsequent impact of fertility.
The aim of this study is to evaluate the impact of cancer diagnosis and treatment on the wishes of fertility before and after the management of cancer of the patients in question, on the recovery of menstrual cycles and the quality of sexual life of these patients.
The investigators hope to improve the pre-therapeutic evaluation of women wishing to implement measures to preserve fertility, to assist women wishing to consider this type of project after cytotoxic treatments and accompany women suffering from a change in self-image that has an impact on their quality of life. These results could help to sensitize the doctors to the difficulties encountered by young women and to improve and/or to strengthen the global and adapted care of these patients.
Read the detailed description
Selection criteria :
- Patient with non-metastatic breast cancer ;
- Age of patient between 18 and 40 years at histological diagnosis ;
- Patient treated with neoadjuvant or adjuvant chemotherapy with or without radiotherapy or endocrine therapy ;
- Patient who have completed their chemotherapy and/or radiotherapy treatment for at least 3 months at the time of questionnaire dispatch ;
- Patient informed of the study (patient must have received the informed consent document and doesn't opposed to it) and who answered to the specific questionnaire of the study ;
Main objective :
=> Describe the impact of diagnosis and the breast cancer care on fertility in patients younger than 40 years.
Secondary objectives :
- Describe the patient population (age, type of histological grade, treatments).
- Describe the recovery of menstrual cycle after chemotherapy (occurrence of menstrual cycles and regularity).
- Describe fertility after treatment.
- Describe the sexual impact (adverse events related to diagnosis and therapeutic care) through an optional part of questionnaire.
- Describe the impact of breast cancer diagnosis on the couple's life.
- Describe the impact on body image (body image satisfaction, breast reconstruction).
- Conditions
- Breast Cancer Female
- Keywords
- breast cancer, young women
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the impact of diagnosis and the breast cancer care on fertility in patients younger than 40 years
measurement of menstrual cycles
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start15 Sep 2017
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Privé des Côtes d'Armor (HPCA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jérôme Martin-Babau, Hôpital Privé des Côtes d'Armor (HPCA)
- Investigators
- Jérôme Martin-Babau, Principal investigator, Hôpital Privé des Côtes d'Armor (HPCA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470935
- Sponsor's protocol ID
- ARTEMIS
- Acronym
- ARTEMIS
- Status last verified
- Jan 2019
- First submitted
- 23 Oct 2017
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Study Evaluating the Gynecological Impact of Diagnosis and Treatment of Breast Cancer in Patients Younger Than 40 Years (ARTEMIS)
- ClinicalTrials.gov ID
- NCT03470935
- Acronym / sponsor ID
- ARTEMIS / ARTEMIS
- Conditions
- Breast Cancer Female
- Keywords
- breast cancer, young women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hôpital Privé des Côtes d'Armor (HPCA)University, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 20 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brest cancer is the most common cancer in women in France with 52.000 new cases diagnosed in 2010 including nearly 6.000 women younger than 40.
The improvement of the fertility conservation of cancer patients is one of the goals put forward by the french Cancer Plan (Objective 8.1).
The issue of fertility after a breast cancer is a frequently raised subjects by the concerned couples today. The improvement in prognosis due to therapeutic advances combined with the increasing age of the first pregnancy and in the recomposed couples bring number of young women between 35 and 40 years followed for breast cancer today to raise these questions with their oncologists.
Young women have a greater risk to develop agressive tumors requiring a mulitimodal treatment whose general and gonadic side effects can be important and permanently impact the reproductive capacity. At the time of diagnosis, almost 50% of these young patients report that they want to consider a later pregnancy but no data are available on the evolution of this wish over time although it is known that anti-cancer treatments have a serious impact on future possibilities of pregnancy(s).
The sequential chemotherapy regimen prescribed in adjuvant or neo-adjuvant situation includes intercaling agents (antracyclines) and an alkylating agent (cyclophosphamide) partially responsible for subsequent fertility disorders. In addition, a chemotherapy-induced amenorrhea (CAI) occurs in 50 to 80% of women according to the studies, the latter is sometines definitive and sequellar of treatment. However, few data describe the time of recovery of menstrual cycles in women with CAI and subsequent impact of fertility.
The aim of this study is to evaluate the impact of cancer diagnosis and treatment on the wishes of fertility before and after the management of cancer of the patients in question, on the recovery of menstrual cycles and the quality of sexual life of these patients.
The investigators hope to improve the pre-therapeutic evaluation of women wishing to implement measures to preserve fertility, to assist women wishing to consider this type of project after cytotoxic treatments and accompany women suffering from a change in self-image that has an impact on their quality of life. These results could help to sensitize the doctors to the difficulties encountered by young women and to improve and/or to strengthen the global and adapted care of these patients.
Detailed description
Selection criteria :
- Patient with non-metastatic breast cancer ;
- Age of patient between 18 and 40 years at histological diagnosis ;
- Patient treated with neoadjuvant or adjuvant chemotherapy with or without radiotherapy or endocrine therapy ;
- Patient who have completed their chemotherapy and/or radiotherapy treatment for at least 3 months at the time of questionnaire dispatch ;
- Patient informed of the study (patient must have received the informed consent document and doesn't opposed to it) and who answered to the specific questionnaire of the study ;
Main objective :
=> Describe the impact of diagnosis and the breast cancer care on fertility in patients younger than 40 years.
Secondary objectives :
- Describe the patient population (age, type of histological grade, treatments).
- Describe the recovery of menstrual cycle after chemotherapy (occurrence of menstrual cycles and regularity).
- Describe fertility after treatment.
- Describe the sexual impact (adverse events related to diagnosis and therapeutic care) through an optional part of questionnaire.
- Describe the impact of breast cancer diagnosis on the couple's life.
- Describe the impact on body image (body image satisfaction, breast reconstruction).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients aged between 18 and 40 years at the time of diagnosis of non-metastatic breast cancer and having completed their radiotherapy and/or chemotherapy treatment(s) for at least 3 months
Key inclusion criteria (5 listed)
- Patient with non-metastatic breast cancer ;
- Age of patient between 18 and 40 years at histological diagnosis ;
- Patient treated with neoadjuvant or adjuvant chemotherapy with or without radiotherapy or endocrine therapy ;
- Patient who have completed their chemotherapy and/or radiotherapy treatment for at least 3 months at the time of questionnaire dispatch ;
- Patient informed of the study (patient must have received the informed consent document and doesn't opposed to it) and who answered to the specific questionnaire of the study ;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Describe the impact of diagnosis and the breast cancer care on fertility in patients younger than 40 years
Time frame: through study completion, an average of 1 year
measurement of menstrual cycles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jérôme Martin-Babau principal investigator
Hôpital Privé des Côtes d'Armor (HPCA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female, run by Hôpital Privé des Côtes d'Armor (HPCA) at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the impact of diagnosis and the breast cancer care on fertility in patients younger than 40 years (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.