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Fertility Preservation in Young Women With Cancer

NCT ID: NCT02878434

Last Updated: 2020-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-23

Study Completion Date

2032-07-31

Brief Summary

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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

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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.

Conditions

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Cancer Fertility

Keywords

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Cancer Fertility Pregnancy Chemotherapy Radiotherapy Long term Follow up

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

No interventions assigned to this group

control group

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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NKI-AvL

UNKNOWN

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role collaborator

N.N. Blokchin NMRCO

UNKNOWN

Sponsor Role collaborator

University Hospital, Gasthuisberg

OTHER

Sponsor Role lead

Responsible Party

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Frederic Amant

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frédéric Amant, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Gasthuisberg & KU Leuven, Belgium

Locations

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UZ Gasthuisberg, Katholieke Universiteit Leuven

Leuven, , Belgium

Site Status RECRUITING

The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, , Netherlands

Site Status RECRUITING

Countries

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Belgium Netherlands

Central Contacts

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Katrien Van Tornout

Role: CONTACT

Phone: +3216342876

Email: [email protected]

Facility Contacts

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Katrien Van Tornout

Role: primary

Christianne Lok, MD, PhD

Role: primary

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form: adult

View Document

Document Type: Informed Consent Form: child -18y

View Document

Document Type: Informed Consent Form: parent for child -18y

View Document

Related Links

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http://www.cancerinpregnancy.org

This site provides background information on the problem of cancer in pregnancy and cancer and fertility

Other Identifiers

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INCIP Fer

Identifier Type: -

Identifier Source: org_study_id