Clinical trial NCT02878434: Fertility Preservation in Young Women With Cancer
Official title: Fertility Preservation in Young Women With Cancer: an International Registration Study From the International Network on Cancer, Infertility and Pregnancy (INCIP)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Fertility
Keywords: Cancer
Fertility
Pregnancy
Chemotherapy
Radiotherapy
Long term
Follow up
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
Collaborators: name: NKI-AvL
name: Medical University of Vienna
name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Oslo University Hospital
name: Haukeland University Hospital
name: N.N. Blokchin NMRCO
First posted: 2016-08-25
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 0
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All women diagnosed with cancer for whom a fertility preserving cancer treatment is applied will be considered for inclusion.

Brief summary: The researchers aim to record the incidence, treatment and long term follow up of fertility preserving cancer treatment. Both the oncological and fertility outcome are recorded.

Study population: All patients with a cancer for whom a fertility preserving cancer treatment is applied. The results of the study population are compared to young women undergoing standard cancer treatment.

Detailed description: Cancer is the second leading cause of death during the reproductive years. The long term survival improves for most cancers, reaching 80% for pediatric cancer and more than 70% for cancers in adults between 20 and 49 years of age. Early detection and improvements in cancer treatment contribute to these figures. As a result, quality of life of which preservation of fertility is one aspect, becomes more important. Fertility may however be influenced by surgery and by the gonadotoxic effects of chemo and/or radiotherapy. Therefore, fertility sparing treatments are offered to young patients in order to maintain the wish to conceive after cancer treatment. This however is associated with deviation of standard treatment and many different strategies are applied among different centers. In addition, there is a lack of studies investigating the oncological safety of these fertility sparing treatment protocols. The results of this study will enable us to better inform clinicians and patients on the efficacy of fertility sparing cancer treatment.

Objective:

To record the incidence, treatment and long term follow up of fertility preserving cancer treatment. Both the oncological and fertility outcome are recorded.

Study design: International multicentre prospective observational trial

Study population: All patients with a cancer for whom a fertility preserving cancer treatment is applied. The results of the study population are compared to young women undergoing standard cancer treatment.

Main study parameters/endpoints:

Registration of cancer diagnosis, treatment and outcome. Both the oncologic and fertility outcome is registered.

All patients receive fertility sparing cancer treatment on their specific request.

Eligibility criteria: Inclusion Criteria:

* Young women who want to preserve their fertility during cancer treatment. Patients need to give their signed and written informed consent to participate in the study.

Exclusion Criteria:

* Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent

Primary outcomes:
measure: Fertility Outcome
timeFrame: 10 years
Secondary outcomes:
measure: Oncological Outcome
timeFrame: 5 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Gasthuisberg, Katholieke Universiteit Leuven
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Study officials:
affiliation: UZ Gasthuisberg & KU Leuven, Belgium
name: Frédéric Amant, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: