Fertility IssuesFERTITOPNCT05048771
Fertility and Temporality in Pediatric Oncology
An observational study of Fertility Issues and Childhood Cancer, run by Central Hospital, Nancy, France at 5 sites in France.
Trial summary
Background: When a cancer is diagnosed in a child, the urgency is to take therapeutic actions. Children and their families face the reality of cancer and the reality of the treatments that, in addition to be overwhelming, might cause infertility. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Fertility Issues, Childhood Cancer, Psychology, Social
- What is being tested?
- Questionnaire
- How many people
- 300 participants
- Where
- 5 sitesFrance
- Study dates
- Sep 2021to Mar 2024
- 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 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents and young adults treated for childhood cancer in one of the five hospital of the Great Est region or France having a follow-up by a pediatric oncologist.
Who may be able to join
- age between 15 -25
- having been diagnosed with cancer during childhood or adolescence,
- having finished the treatments and being in remission for at least 2 years
Who cannot join
- Recurrence of cancer at the time of the study
- Lack of cognitive autonomy to be able to agree to participate in the study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
University Hospital of Besançon
Besançon
Christophe Roux, +33381218698, christophe.roux@univ-fcomte.fr
University Hospital of Dijon
Dijon
Patricia Fauque, +33380295031, patricia.fauque@chu-dijon.fr
University Hospital of Nancy, France
Nancy, 54000
Ludovic Mansuy, MD, +33617750930, lu.mansuy@chru-nancy.fr
University hospital of Reims
Reims
Beatrice Delepine, 0326788584, bdelepine@chu-reims.fr
University hospital of Strasbourg
Strasbourg
Marius Teletin, +33369553423, Marius.teletin@chrustrasbourg.fr
About this study
Background: When a cancer is diagnosed in a child, the urgency is to take therapeutic actions. Children and their families face the reality of cancer and the reality of the treatments that, in addition to be overwhelming, might cause infertility. Immediately after the diagnosis, a fertility preservation consultation is proposed to discuss fertility preservation options. In practice, it is often difficult to organize.
Several years after the end of treatments, a second information consultation is proposed to inform about fertility, evaluate the fertility status and propose a second line of Fertility Preservation when possible. The literature reflects a lack of knowledge regarding the degree of fertility-related distress among pediatric cancer patients as well as insufficient tools at the disposal of medical doctors and nurses to discuss about reproduction with children and young adolescents.
Read more
Project objective: Understand how young cancer patients and their parents felt about sterility risk at the diagnostic time and now as cured adolescents.
Patients \& Methods:
300 patients (15-25 years) from 5 different centers (20 patients per year and per center for 3 years) will be included in this study at the information consultation. They will be surveyed through self-administered questionnaires and semidirected interviews that will 1) retrieve perceptions and emotional being of children during the fertility preservation consultation; 2) assess the decision-making process of parents and family since the fertility preservation consultation through the patient's speech; 3) interview the patients about personal history and experience of cancer and consequences of potential fertility impairment and 4) survey the current experience and projections in the future and evaluate their reaction to the proposition of a second line of Fertility Preservation.
Expected results: what points should the doctor / psychologist discuss with pediatric cancer survivors in response to their fertility stress? and how to do it? for better initial and follow-up care to improve their quality of life after cancer.
- Conditions
- Fertility Issues, Childhood Cancer, Psychology, Social
- Being tested
- Questionnaire
- Medical subject headings
- Infertility, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Also called Interview
Patients will be surveyed through self-administered questionnaires and semidirected interviews with a psychologist
| Study group | Role | What they receive |
|---|---|---|
| FERTITOP | 300 patients (15-25 years) from 5 different hospitals (University Hospitals of Nancy, Strasbourg, Reims, Besançon, Dijon (France)) who have finished all cancer treatments for at least 2 years. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the impact of infertility on psychological health
Patients will report the outcomes of the infertility risks on the questionnaire provided in this study.
Positive and negative impacts will be questioned.
Measured: december 2023
Secondary outcomes (1)
Develop a decision aid tool for clinicians designed to increase referral for fertility preservation
Using the factors that facilitate or hinder referral to fertility preservation to create a tool for clinicians designed to increase the referral for fertility preservation of children and adolescents with cancer
Measured: december 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study startSep 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility IssuesStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France
- Responsible party
- Principal investigator, Isabelle KOSCINSKI, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048771
- Sponsor's protocol ID
- 2019PI269
- Acronym
- FERTITOP
- Status last verified
- Sep 2021
- First submitted
- 25 Aug 2021
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility and Temporality in Pediatric Oncology
- ClinicalTrials.gov ID
- NCT05048771
- Acronym / sponsor ID
- FERTITOP / 2019PI269
- Conditions
- Fertility Issues, Childhood Cancer, Psychology, Social
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- National Cancer Institute, France
- Study start
- Sep 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 17 Sep 2021 (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.
Background: When a cancer is diagnosed in a child, the urgency is to take therapeutic actions. Children and their families face the reality of cancer and the reality of the treatments that, in addition to be overwhelming, might cause infertility. Immediately after the diagnosis, a fertility preservation consultation is proposed to discuss fertility preservation options. In practice, it is often difficult to organize.
Several years after the end of treatments, a second information consultation is proposed to inform about fertility, evaluate the fertility status and propose a second line of Fertility Preservation when possible. The literature reflects a lack of knowledge regarding the degree of fertility-related distress among pediatric cancer patients as well as insufficient tools at the disposal of medical doctors and nurses to discuss about reproduction with children and young adolescents.
Project objective: Understand how young cancer patients and their parents felt about sterility risk at the diagnostic time and now as cured adolescents.
Patients \& Methods:
300 patients (15-25 years) from 5 different centers (20 patients per year and per center for 3 years) will be included in this study at the information consultation. They will be surveyed through self-administered questionnaires and semidirected interviews that will 1) retrieve perceptions and emotional being of children during the fertility preservation consultation; 2) assess the decision-making process of parents and family since the fertility preservation consultation through the patient's speech; 3) interview the patients about personal history and experience of cancer and consequences of potential fertility impairment and 4) survey the current experience and projections in the future and evaluate their reaction to the proposition of a second line of Fertility Preservation.
Expected results: what points should the doctor / psychologist discuss with pediatric cancer survivors in response to their fertility stress? and how to do it? for better initial and follow-up care to improve their quality of life after cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FERTITOP | – | Other: Questionnaire300 patients (15-25 years) from 5 different hospitals (University Hospitals of Nancy, Strasbourg, Reims, Besançon, Dijon (France)) who have finished all cancer treatments for at least 2 years. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents and young adults treated for childhood cancer in one of the five hospital of the Great Est region or France having a follow-up by a pediatric oncologist.
Key inclusion criteria (3 listed)
- age between 15 -25
- having been diagnosed with cancer during childhood or adolescence,
- having finished the treatments and being in remission for at least 2 years
Key exclusion criteria (2 listed)
- Recurrence of cancer at the time of the study
- Lack of cognitive autonomy to be able to agree to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: InterviewPatients will be surveyed through self-administered questionnaires and semidirected interviews with a psychologist | Other | FERTITOP |
Primary outcome
Evaluate the impact of infertility on psychological health
Time frame: december 2023
Patients will report the outcomes of the infertility risks on the questionnaire provided in this study. Positive and negative impacts will be questioned.
1 secondary outcome
Develop a decision aid tool for clinicians designed to increase referral for fertility preservation
Time frame: december 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility Issues and Childhood Cancer, run by Central Hospital, Nancy, France at 5 sites 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the impact of infertility on psychological health (time frame: december 2023). 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 17 Sep 2021.